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Travere Therapeutics to Present New FILSPARI® (sparsentan) Data at the 62nd ERA Congress
Data from SPARTACUS and PROTECT OLE to show significant proteinuria reduction when replacing RASi with FILSPARI and when FILSPARI is used in combination with SGLT2i New mechanistic data to show FILSPARI protects against IgA deposition in the kidney SAN DIEGO, June 03, 2025--(BUSINESS WIRE)--Travere Therapeutics, Inc., (Nasdaq: TVTX) today announced that the Company will present seven abstracts at the upcoming European Renal Association (ERA) Congress in Vienna, Austria, June 4-7. Presentations will include new data on the use of FILSPARI in IgA nephropathy (IgAN) from the Phase 2 SPARTACUS Study which demonstrated that FILSPARI provided clinically meaningful benefits in adults with IgAN who replaced their renin-angiotensin system inhibitor (RASi) with FILSPARI while receiving stable sodium-glucose cotransporter-2 inhibitor (SGLT2i) therapy. A presentation on results from the open label extension (OLE) of the Phase 3 PROTECT Study will show that patients previously treated with maximum labeled irbesartan experienced significant proteinuria reduction after switching to FILSPARI in the study. In a preclinical model of IgAN, FILSPARI protected from mesangial deposition of IgA, suggesting a potential role of endothelin-1 and angiotensin II as modulators of disease activity in IgAN. Data from the gddY mouse model of IgAN will offer new insight into the pathogenesis of IgAN as a tissue-specific autoimmune disease. In focal segmental glomerulosclerosis (FSGS), the Company will share a data analysis from the Phase 3 DUPLEX Study showing that partial and complete proteinuria remission were achieved earlier and more frequently with FILSPARI than irbesartan. The Company will also present preclinical data in an animal model of immune-mediated FSGS showing that optimized dual endothelin and angiotensin blockade with FILSPARI helps protect the integrity of the glomerular filtration barrier, reducing glomerular permeability and lowering albuminuria. "The breadth of data we're presenting underscores our confidence in the role FILSPARI can serve as foundational therapy for rare kidney diseases," said Jula Inrig, M.D., chief medical officer of Travere Therapeutics. "These findings provide further evidence that FILSPARI can decrease the risk of IgAN disease progression. We are deeply committed to advancing research and delivering innovative therapies that can make a meaningful difference for people living with IgAN and FSGS." European Renal Association Congress Presentations Sparsentan Added to Stable Sodium-Glucose Cotransporter-2 Inhibitors (SGLT2is) in Adults with IgA Nephropathy (IgAN) in the Phase 2 SPARTACUS Trial Abstract: No. 1916Session: Glomerular & Tubulointerstitial DiseasesDate: June 6, 2025, 9:00-9:05 CESTLocation: Focused Oral Room 3 Effects of Sparsentan After Maximized Angiotensin Receptor Blocker (ARB) Treatment in Patients with IgA Nephropathy (IgAN) in the PROTECT Trial Abstract: No. 1920Session: Glomerular & Tubulointerstitial DiseasesDate: June 6, 2025, 9:05-9:10 CESTLocation: Focused Oral Room 3 Patients with Focal Segmental Glomerulosclerosis (FSGS) Achieved Low Proteinuria Targets Earlier and More Often with Sparsentan (SPAR) vs. Irbesartan (IRB) in DUPLEX Abstract: No. 2444Session: Glomerular & Tubulointerstitial DiseasesDate: June 6, 2025, 16:40-16:45 CESTLocation: Focused Oral Room 2 Kidney Outcomes and Effects of Proteinuria in Alport Syndrome: a Longitudinal Analysis of Using Data from the National Registry of Rare Kidney Diseases (RaDaR) Abstract: No. 2883Session: FC 12: Membranous Nephropathy and Other Rare DiseasesDate: June 5, 2025, 18:12-18:24 CESTLocation: Hall K Population Modeling Depicts the Mutational Burden of NPHS2 (Podocin) Nephropathy and Reveals an Undiagnosed Adult-Onset Genetic Cohort Abstract: No. 1346Session: Glomerular & Tubulointerstitial DiseasesDate: June 5, 2025, 15:00-15:06 CESTLocation: XWall I Mozart Eine Kleine Nachtmusik Sparsentan Reversibly Decreases Mesangial IgA Deposition in gddY Mice; A Possible Role for Mesangial-Cell-Surface Autoantigen Expression Abstract: No. 733Session: Glomerular & Tubulointerstitial DiseasesDate: June 5, 2025, 8:33-8:39 CESTLocation: Focused Oral Room 2 Sparsentan Reduces Glomerular Dysfunction and Proteinuria in a Rat Model of Serum-Factor-Induced Nephrotic Syndrome Abstract: No. 272Session: Glomerular & Tubulointerstitial DiseasesDate: June 5, 2025, 9:48-9:51 CESTLocation: Hall K About IgA Nephropathy IgA nephropathy (IgAN), also called Berger's disease, is a rare progressive kidney disease characterized by the buildup of immunoglobulin A (IgA), a protein that helps the body fight infections, in the kidneys. The deposits of IgA cause a breakdown of the normal filtering mechanisms in the kidney, leading to blood in the urine (hematuria), protein in the urine (proteinuria) and a progressive loss of kidney function. Other symptoms of IgAN may include swelling (edema) and high blood pressure. IgAN is the most common type of primary glomerulonephritis worldwide and a leading cause of kidney failure due to glomerular disease. IgAN is estimated to affect up to 150,000 people in the U.S. and is one of the most common glomerular diseases in Europe and Japan. About Focal Segmental Glomerulosclerosis Focal segmental glomerulosclerosis (FSGS) is a rare proteinuric kidney disorder in both children and adults that is estimated to affect more than 40,000 patients in the U.S. with similar prevalence in Europe. The disorder is defined by progressive scarring of the kidney and often leads to kidney failure. FSGS is characterized by proteinuria, where protein leaks into the urine due to a breakdown of the normal filtration mechanism in the kidney. Once in the urine, protein is considered to be toxic to other parts of the kidney, especially the tubules, and is believed to contribute to further disease progression. Other common symptoms include swelling in parts of the body, known as edema, as well as low blood albumin levels, abnormal lipid profiles and hypertension. Sparsentan is not approved for use in FSGS. There is currently no approved pharmacologic indicated for the treatment of FSGS. About Travere Therapeutics At Travere Therapeutics, we are in rare for life. We are a biopharmaceutical company that comes together every day to help patients, families and caregivers of all backgrounds as they navigate life with a rare disease. On this path, we know the need for treatment options is urgent – that is why our global team works with the rare disease community to identify, develop and deliver life-changing therapies. In pursuit of this mission, we continuously seek to understand the diverse perspectives of rare patients and to courageously forge new paths to make a difference in their lives and provide hope – today and tomorrow. For more information, visit FILSPARI® (sparsentan) U.S. Indication FILSPARI (sparsentan) is indicated to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression. IMPORTANT SAFETY INFORMATION BOXED WARNING: HEPATOTOXICITY AND EMBRYO-FETAL TOXICITY Because of the risks of hepatotoxicity and birth defects, FILSPARI is available only through a restricted program called the FILSPARI REMS. Under the FILSPARI REMS, prescribers, patients and pharmacies must enroll in the program. Hepatotoxicity Some Endothelin Receptor Antagonists (ERAs) have caused elevations of aminotransferases, hepatotoxicity, and liver failure. In clinical studies, elevations in aminotransferases (ALT or AST) of at least 3-times the Upper Limit of Normal (ULN) have been observed in up to 3.5% of FILSPARI-treated patients, including cases confirmed with rechallenge. Measure transaminases and bilirubin before initiating treatment and monthly for the first 12 months, and then every 3 months during treatment. Interrupt treatment and closely monitor patients who develop aminotransferase elevations more than 3x ULN. FILSPARI should generally be avoided in patients with elevated aminotransferases (>3x ULN) at baseline because monitoring for hepatotoxicity may be more difficult and these patients may be at increased risk for serious hepatotoxicity. Embryo-Fetal Toxicity FILSPARI can cause major birth defects if used by pregnant patients based on animal data. Therefore, pregnancy testing is required before the initiation of treatment, during treatment and one month after discontinuation of treatment with FILSPARI. Patients who can become pregnant must use effective contraception before the initiation of treatment, during treatment, and for one month after discontinuation of treatment with FILSPARI. Contraindications FILSPARI is contraindicated in patients who are pregnant. Do not coadminister FILSPARI with angiotensin receptor blockers (ARBs), ERAs, or aliskiren. Warnings and Precautions Hepatotoxicity: Elevations in ALT or AST of at least 3-fold ULN have been observed in up to 3.5% of FILSPARI-treated patients, including cases confirmed with rechallenge. While no concurrent elevations in bilirubin >2-times ULN or cases of liver failure were observed in FILSPARI-treated patients, some ERAs have caused elevations of aminotransferases, hepatotoxicity, and liver failure. To reduce the risk of potential serious hepatotoxicity, measure serum aminotransferase levels and total bilirubin prior to initiation of treatment and monthly for the first 12 months, then every 3 months during treatment. Advise patients with symptoms suggesting hepatotoxicity (nausea, vomiting, right upper quadrant pain, fatigue, anorexia, jaundice, dark urine, fever, or itching) to immediately stop treatment with FILSPARI and seek medical attention. If aminotransferase levels are abnormal at any time during treatment, interrupt FILSPARI and monitor as recommended. Consider re-initiation of FILSPARI only when hepatic enzyme levels and bilirubin return to pretreatment values and only in patients who have not experienced clinical symptoms of hepatotoxicity. Avoid initiation of FILSPARI in patients with elevated aminotransferases (>3x ULN) prior to drug initiation because monitoring hepatotoxicity in these patients may be more difficult and these patients may be at increased risk for serious hepatotoxicity. Embryo-Fetal Toxicity: FILSPARI can cause fetal harm when administered to a pregnant patient and is contraindicated during pregnancy. Advise patients who can become pregnant of the potential risk to a fetus. Obtain a pregnancy test prior to initiation of treatment with FILSPARI, monthly during treatment, and one month after discontinuation of treatment. Advise patients who can become pregnant to use effective contraception prior to initiation of treatment, during treatment, and for one month after discontinuation of treatment with FILSPARI. FILSPARI REMS: Due to the risk of hepatotoxicity and embryo-fetal toxicity, FILSPARI is available only through a restricted program called the FILSPARI REMS. Prescribers, patients, and pharmacies must be enrolled in the REMS program and comply with all requirements ( Hypotension: Hypotension has been observed in patients treated with ARBs and ERAs. There was a greater incidence of hypotension-associated adverse events, some serious, including dizziness, in patients treated with FILSPARI compared to irbesartan. In patients at risk for hypotension, consider eliminating or adjusting other antihypertensive medications and maintaining appropriate volume status. If hypotension develops, despite elimination or reduction of other antihypertensive medications, consider a dose reduction or dose interruption of FILSPARI. A transient hypotensive response is not a contraindication to further dosing of FILSPARI, which can be given once blood pressure has stabilized. Acute Kidney Injury: Monitor kidney function periodically. Drugs that inhibit the renin-angiotensin system (RAS) can cause kidney injury. Patients whose kidney function may depend in part on the activity of the RAS (e.g., patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing acute kidney injury on FILSPARI. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in kidney function while on FILSPARI. Hyperkalemia: Monitor serum potassium periodically and treat appropriately. Patients with advanced kidney disease, taking concomitant potassium-increasing drugs (e.g., potassium supplements, potassium-sparing diuretics), or using potassium-containing salt substitutes are at increased risk for developing hyperkalemia. Dosage reduction or discontinuation of FILSPARI may be required. Fluid Retention: Fluid retention may occur with ERAs, and has been observed in clinical studies with FILSPARI. FILSPARI has not been evaluated in patients with heart failure. If clinically significant fluid retention develops, evaluate the patient to determine the cause and the potential need to initiate or modify the dose of diuretic treatment then consider modifying the dose of FILSPARI. Most common adverse reactions The most common adverse reactions (≥5%) are hyperkalemia, hypotension (including orthostatic hypotension), peripheral edema, dizziness, anemia, and acute kidney injury. Drug interactions Renin-Angiotensin System (RAS) Inhibitors and ERAs: Do not coadminister FILSPARI with ARBs, ERAs, or aliskiren due to increased risks of hypotension, syncope, hyperkalemia, and changes in renal function (including acute renal failure). Strong and Moderate CYP3A Inhibitors: Avoid concomitant use of FILSPARI with strong CYP3A inhibitors. If a strong CYP3A inhibitor cannot be avoided, interrupt FILSPARI treatment. When resuming treatment with FILSPARI, consider dose titration. Monitor blood pressure, serum potassium, edema, and kidney function regularly when used concomitantly with moderate CYP3A inhibitors. Concomitant use with a strong CYP3A inhibitor increases sparsentan exposure which may increase the risk of FILSPARI adverse reactions. Strong CYP3A Inducers: Avoid concomitant use with a strong CYP3A inducer. Concomitant use with a strong CYP3A inducer decreases sparsentan exposure which may reduce FILSPARI efficacy. Antacids and Acid Reducing Agents: Administer FILSPARI 2 hours before or after administration of antacids. Avoid concomitant use of acid reducing agents (histamine H2 receptor antagonist and PPI proton pump inhibitor) with FILSPARI. Sparsentan exhibits pH-dependent solubility. Antacids or acid reducing agents may decrease sparsentan exposure which may reduce FILSPARI efficacy. Non-Steroidal Anti-Inflammatory Agents (NSAIDs), Including Selective Cyclooxygenase-2 (COX-2) Inhibitors: Monitor for signs of worsening renal function with concomitant use with NSAIDs (including selective COX-2 inhibitors). In patients with volume depletion (including those on diuretic therapy) or with impaired kidney function, concomitant use of NSAIDs (including selective COX-2 inhibitors) with drugs that antagonize the angiotensin II receptor may result in deterioration of kidney function, including possible kidney failure. CYP2B6, 2C9, and 2C19 Substrates: Monitor for efficacy of concurrently administered CYP2B6, 2C9, and 2C19 substrates and consider dosage adjustment in accordance with the Prescribing Information. Sparsentan decreases exposure of these substrates, which may reduce efficacy related to these substrates. P-gp and BCRP Substrates: Avoid concomitant use of sensitive substrates of P-gp and BCRP with FILSPARI. Sparsentan may increase exposure of these transporter substrates, which may increase the risk of adverse reactions related to these substrates. Agents Increasing Serum Potassium: Monitor serum potassium frequently in patients treated with FILSPARI and other agents that increase serum potassium. Concomitant use of FILSPARI with potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, or other drugs that raise serum potassium levels may result in hyperkalemia. Please see the full Prescribing Information, including BOXED WARNING, for additional Important Safety Information. Forward Looking Statements This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, these statements are often identified by the words "on-track," "positioned," "look forward to," "will," "would," "may," "might," "believes," "anticipates," "plans," "expects," "intends," "potential," or similar expressions. In addition, expressions of strategies, intentions or plans are also forward-looking statements. Such forward-looking statements include, but are not limited to, references to: statements relating to the clinical studies and models described herein, and data to be presented; statements regarding the potential role of FILSPARI as foundational therapy for rare kidney diseases; statements regarding the impact of FILSPARI on IgAN disease progression; statements regarding the goal of advancing research and delivering innovative therapies that can make a meaningful difference for people living with IgAN and FSGS; and statements related to the estimated sizes of patient populations. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties related to the Company's sNDA for FILSPARI in FSGS, including the timing and outcome thereof. There is no guarantee that the FDA will grant approval of FILSPARI for FSGS on the anticipated timeline, or at all. The Company also faces risks and uncertainties related to its business and finances in general, the success of its commercial products, risks and uncertainties associated with its preclinical and clinical stage pipeline, risks and uncertainties associated with the regulatory review and approval process, risks and uncertainties associated with enrollment of clinical trials for rare diseases, and risks that ongoing or planned clinical trials may not succeed or may be delayed for safety, regulatory or other reasons. Specifically, the Company faces risks associated with the ongoing commercial launch of FILSPARI in IgAN, the timing and potential outcome of its and its partners' clinical studies, market acceptance of its commercial products including efficacy, safety, price, reimbursement, and benefit over competing therapies, risks related to the challenges of manufacturing scale-up, risks associated with the successful development and execution of commercial strategies for such products, including FILSPARI, and risks and uncertainties related to the new administration, including but not limited to risks and uncertainties related to tariffs and the funding, staffing and prioritization of resources at government agencies including the FDA. The Company also faces the risk that it will be unable to raise additional funding that may be required to complete development of any or all of its product candidates, including as a result of macroeconomic conditions; risks relating to the Company's dependence on contractors for clinical drug supply and commercial manufacturing; uncertainties relating to patent protection and exclusivity periods and intellectual property rights of third parties; risks associated with regulatory interactions; and risks and uncertainties relating to competitive products, including current and potential future generic competition with certain of the Company's products, and technological changes that may limit demand for the Company's products. The Company also faces additional risks associated with global and macroeconomic conditions, including health epidemics and pandemics, including risks related to potential disruptions to clinical trials, commercialization activity, supply chain, and manufacturing operations. You are cautioned not to place undue reliance on these forward-looking statements as there are important factors that could cause actual results to differ materially from those in forward-looking statements, many of which are beyond our control. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Investors are referred to the full discussion of risks and uncertainties, including under the heading "Risk Factors", as included in the Company's most recent Form 10-K, Form 10-Q and other filings with the Securities and Exchange Commission. 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14 hours ago
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Vera Therapeutics Announces Refinancing of Existing Oxford Debt Facility, Providing up to $500 Million of Term Loans
BRISBANE, Calif., June 03, 2025 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. ('Vera'), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today announced that it has entered into a new credit facility providing for up to $500 million of term loans with its current partner Oxford Finance LLC ('Oxford'). The new credit facility will replace Vera's existing $50 million credit facility. The initial funding of the new credit facility will be in a principal amount of $75 million and is expected to occur on June 4, 2025. Highlights of the new credit facility include: Lowered Interest Rate: Reduced borrowing cost by 320 basis points based on current interest rates. The facility will mature five years from the closing date. Interest will be paid monthly at a rate per annum equal to 1-month SOFR plus 4.95%, subject to a SOFR floor of 3.75%. Increased Capital Availability: Added $450 million of discretionary incremental capacity available in five tranches. At its discretion, Vera may draw up to $50 million from January 1, 2026 through December 31, 2026, not subject to additional performance milestones. Vera has the option to draw $75 million upon accelerated approval of atacicept in immunoglobulin A nephropathy (IgAN), two $50 million tranches post accelerated approval and subject to commercial milestones, and up to $200 million at the mutual discretion of Vera and Oxford. Improved Structure & Financial Flexibility: Extended the interest only period by up to 42 months and maturity by up to 41 months. As a result of this refinancing, Vera will no longer be required to make principal payments in 2026. The new facility also reduced prepayment and final-payment fees and, combined with the reduced interest rate, results in a cost-effective refinancing that significantly lowers Vera's cost of capital. 'We have crossed a significant Vera milestone with the primary endpoint results from the pivotal atacicept ORIGIN 3 trial; and given the data we presented earlier, we expect this to enable a BLA submission to the FDA in the fourth quarter of this year, which may allow for approval and commercial launch in 2026. If approved, we believe that atacicept has the potential to advance the standard of care in IgA nephropathy,' said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. 'The Vera team is well-positioned to build on the success of the lead atacicept development program in IgAN, with the expansion into additional potential indications in other autoimmune kidney diseases and beyond.' The refinancing significantly reduces interest expense and improves financial flexibility and access to capital as compared to the existing credit facility, with the new credit facility having more borrower-favorable terms overall than those under the existing credit facility. The refinancing enhances Vera's ability to generate cash and manage its capital structure efficiently while providing additional working capital flexibility to support commercial launch and strategic initiatives. 'Our partnership with Oxford over the past three years has been key to supporting Vera's growth and we are happy to continue this incredibly productive relationship,' said Sean Grant, Chief Financial Officer of Vera. 'We are also very pleased to be able to execute this non-dilutive transaction in today's market environment with Oxford. Through a competitive process, we secured favorable terms with our current lender, eliminated exit fees from the existing credit facility, and closed the refinancing in a very efficient manner.'A Form 8-K outlining the full terms of the new credit facility will be filed with the Securities and Exchange Commission. Armentum Partners acted as exclusive financial advisor to Vera. Latham and Watkins LLP served as legal advisor to Vera, and Manatt, Phelps and Phillip, LLP served as legal advisor to Oxford. About VeraVera Therapeutics, Inc. is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera's mission is to advance treatments that target the source of immunological diseases in order to change the standard of care for patients. Vera's lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both B-cell Activating Factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgAN and lupus nephritis. In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful. Vera also holds an exclusive license agreement with Stanford University for a novel, next generation fusion protein targeting BAFF and APRIL, known as VT-109, with wide therapeutic potential across the spectrum of B cell mediated diseases. Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK virus (BKV), a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. Vera retains all global developmental and commercial rights to atacicept and MAU868. For more information, please visit Forward-looking StatementsStatements contained in this press release regarding matters, events or results that may occur in the future are 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, Vera's expectations regarding the credit facility and its impact on Vera's business and financial position, Vera's plans to submit a BLA to the FDA and receive FDA approval for atacicept in IgAN and launch it commercially, and, in each case, the timing thereof, atacicept's potential as a treatment for indications beyond IgAN, atacicept's potential to advance the standard of care in IgAN, if approved, and other statements that are not historical fact. Because such statements are subject to risk and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as 'believe,' 'expect,' 'may,' 'plan,' 'potential,' 'will' and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Vera's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks related to the regulatory approval process, results of earlier clinical trials may not be obtained in later clinical trials, preliminary results may not be predictive of topline results, risks and uncertainties associated with Vera's business in general, the impact of macroeconomic and geopolitical events, and the other risks described in Vera's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. Vera undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. For more information, please contact: Investor Contact:Joyce AllaireLifeSci Advisors212-915-2569jallaire@ Media Contact:Debra CharlesworthVera Therapeutics415-854-8051corporatecommunications@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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Vera drug scores in closely watched study in rare kidney disease
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. An experimental medicine from Vera Therapeutics succeeded in a late-stage trial in a rare kidney disease, positioning the company to discuss an approval application with U.S. regulators in the near future. According to Vera, the drug, called atacicept, met its main goal in a Phase 3 trial in IgA nephropathy, a chronic condition that can lead to kidney failure. After 36 weeks of treatment, atacicept was associated with a 42% reduction versus a placebo — and a 46% decline from the study's start — in the amount of protein in participants' urine, an important marker of kidney health. Without providing specifics, Vera said atacicept's other efficacy results were 'consistent with or better than' what was observed in mid-stage testing and had a safety profile 'comparable to placebo.' The company will share the data with the Food and Drug Administration in the coming weeks and intends to file an accelerated approval request in the fourth quarter. Vera is one of the leaders in a push to develop new treatments for IgA nephropathy, or IgAN, a progressive disease that damages the kidneys. Some estimates hold 130,000 to 150,000 people in the U.S. have IgAN. While several medicines are approved, they don't totally stop patients' kidney function from deteriorating. That need, and a better understanding of the disease's biology, has led to an uptick in dealmaking involving IgAN. Drugs recently launched by Travere Therapeutics and Calliditas Therapeutics have performed well, too. Vera's atacicept is part of a newer wave of therapies aimed at immune-mediated drivers of the disease. Like several others in development, it targets a pair of cytokines called BAFF and April that stimulate production of the 'autoantibodies' that mistakenly target the body's own tissue. In Phase 2 testing, the drug stabilized a key marker of disease progression so well that some analysts viewed the findings as the bar for other competitors to meet. The findings also heightened anticipation for Vera's Phase 3 study. According to Marshall Fordyce, Vera's founder and CEO, the drug's effects on urine protein in the trial significantly 'exceed the bar' for what U.S. regulators have accepted in granting an accelerated approval to several other medications. The figure Vera reported also represents the 'deepest reduction' in a late-stage stage study in IgAN patients to date, he wrote in an email. Investors appear to agree, as Vera's shares climbed by nearly 60%, to over $30 apiece, in early trading on Monday. Vera has competition ahead, as Otsuka Pharmaceutical could win approval of a similar type of medicine by late November. The company will present detailed Phase 3 study results at a medical meeting on Friday and, though cross-trial comparisons come with caveats, analysts and investors will be paying close attention to how the two treatments stack up. Vera, for its part, believes the market for IgAN treatments is 'ripe for disruption,' according to Fordyce. There are currently 'low levels of approved product saturation,' Fordyce wrote, and newer drugs like atacicept 'may represent a differentiated approach.' The company is also studying the drug in people whose are at 'moderate' or 'low' risk of disease progression, which, if successful, could boost its sales potential. The Phase 3 trial, meanwhile, will continue on while Vera accumulates data on atacicept's impact on kidney function. Those findings are expected in 2027. Vera's results have implications for drugmakers like Biogen and Vertex Pharmaceuticals, which have both cut deals for companies developing IgAN drugs. Vertex has said it could file for approval of a drug that also targets BAFF and April early next year, if data are supportive.
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Vera Therapeutics Announces Atacicept Achieved 46% Proteinuria Reduction in ORIGIN Phase 3 Trial in Adults with IgA Nephropathy
Atacicept ORIGIN Phase 3 trial met the primary endpoint of reduction in proteinuria (UPCR) at week 36; participants receiving atacicept achieved a 46% reduction from baseline and 42% reduction compared to placebo at week 36 (p<0.0001) Other prespecified endpoints achieved similar or better results compared to the ORIGIN Phase 2b clinical trial — per FDA guidance, Vera is not sharing eGFR results at this time while the ORIGIN 3 placebo-controlled trial continues The safety profile of atacicept was favorable, and comparable to placebo Vera plans to meet with FDA in the coming weeks to discuss these results and the regulatory pathway; Vera currently plans to submit a Biologics License Application (BLA) for accelerated approval to the FDA in 4Q 2025; ORIGIN 3 trial continues with two-year results expected in 2027 Vera will host a conference call and webcast at 8:00 am ET on Monday, June 2 BRISBANE, Calif., June 02, 2025 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA) today announced that the primary endpoint was met in the ORIGIN Phase 3 trial of atacicept for the treatment of immunoglobulin A nephropathy (IgAN) in adults. Participants treated with atacicept achieved a 46% reduction from baseline in proteinuria as measured by 24-hour urine protein-to-creatinine ratio (UPCR), with a statistically significant and clinically meaningful 42% reduction in UPCR compared to placebo (p<0.0001) at week 36. For other prespecified endpoints, atacicept treatment also demonstrated results that were consistent with or better than those previously observed in the ORIGIN Phase 2b trial.1 The safety profile of atacicept in this analysis was favorable, and comparable to placebo. Vera plans to share these results with the FDA in the coming weeks, and full results will be submitted to the American Society of Nephrology Kidney Week. 'ORIGIN 3 is the first Phase 3 clinical trial in IgAN to demonstrate this magnitude of UPCR reduction compared to placebo at week 36. These results convincingly demonstrate the impact of atacicept to reduce proteinuria,' said Richard Lafayette, M.D., F.A.C.P., Professor of Medicine, Nephrology and Director of the Glomerular Disease Center at Stanford University Medical Center, and a primary investigator for both ORIGIN 2b and ORIGIN 3. 'If approved, we believe that atacicept has the potential to advance the standard of care in IgAN as the first dual BAFF/APRIL inhibitor. We currently plan to submit a BLA for atacicept in IgAN to the FDA in the fourth quarter of this year, which may allow for US approval and commercial launch in 2026. We are grateful to the study participants, their families and caregivers, the study investigators and staff, our research partners, and the Vera team for their ongoing commitment and dedication to this important research,' said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. 'Vera aspires to evolve the practice of kidney medicine with the hope that, one day, patients may no longer face a future of dialysis or transplantation. Vera is poised for potential commercial launch of atacicept in 2026 and to pursue development in additional indications in other autoimmune kidney diseases and beyond.' 'Patients with IgA nephropathy, as well as their families and care partners, suffer from clinical uncertainty and the horrible outcome of kidney failure. In addition to clinical signs and symptoms, IgAN has a devastating impact on quality of life and mental wellbeing. I'm thrilled with the progress that is being made in developing new treatments for patients,' said Bonnie Schneider, Director and Cofounder of the IgA Nephropathy Foundation. ORIGIN 3 is an ongoing global, multicenter, randomized, double-blind, placebo-controlled Phase 3 trial of 431 adults with IgA nephropathy. Participants were randomized 1:1 to atacicept 150 mg, self-administered at home via once weekly subcutaneous injection, or placebo. The primary efficacy endpoint was the change in 24-hour UPCR compared to placebo at the 36-week interim analysis. The trial continues in a placebo-controlled blinded manner to evaluate the change in kidney function over two years as measured by eGFR and is expected to complete in 2027. For more information about the ORIGIN 3 clinical trial (NCT04716231), please visit The Company will host an investor call and webcast to discuss the data update at 8:00 AM ET on Monday, June 2. Investors Dial-in: 1-877-425-9470 Int'l Investors Dial-in: 1-201-389-0878 Conference ID: 13754147 Webcast: The live webcast will be available on the Company's Investor Calendar, with the recording and presentation available immediately following the event. References1. Barratt J, et al. JASN 2024 About Atacicept Atacicept is an investigational recombinant fusion protein that contains the soluble transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor that binds to the cytokines B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL). These cytokines are members of the tumor necrosis factor family that promote B-cell survival and autoantibody production associated with certain autoimmune diseases, including IgAN, other autoimmune kidney diseases and lupus nephritis. The ORIGIN Phase 2b clinical trial of atacicept in IgAN met its primary and key secondary endpoints, with statistically significant and clinically meaningful proteinuria reductions and stabilization of eGFR versus placebo through 36 weeks. The safety profile during the randomized period was comparable between atacicept and placebo. Through 96 weeks, atacicept demonstrated further improvements in Gd-IgA1, hematuria, and proteinuria, as well as stabilization of eGFR reflecting a profile consistent with that of the general population without IgAN. Atacicept has received FDA Breakthrough Therapy Designation for the treatment of IgAN, which reflects the FDA's determination that, based on an assessment of data from the ORIGIN Phase 2b clinical trial, atacicept may demonstrate substantial improvement on a clinically significant endpoint over available therapies for patients with IgAN. Vera believes atacicept is positioned for best-in-class potential, targeting B cells to reduce autoantibodies and having been administered to more than 1,500 patients in clinical trials across different indications. About VeraVera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera's mission is to advance treatments that target the source of immunological diseases in order to change the standard of care for patients. Vera's lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both BAFF and APRIL, which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgAN and lupus nephritis. In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful. Vera also holds an exclusive license agreement with Stanford University for a novel, next generation fusion protein targeting BAFF and APRIL, known as VT-109, with wide therapeutic potential across the spectrum of B cell mediated diseases. Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK virus (BKV), a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. Vera retains all global developmental and commercial rights to atacicept and MAU868. For more information, please visit Forward-looking StatementsStatements contained in this press release regarding matters, events or results that may occur in the future are 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, atacicept's potential to be a best-in-class therapy for patients with IgAN, atacicept's potential as a treatment for indications beyond IgAN, Vera's expectations concerning other predefined endpoints in the Phase 3 ORIGIN trial, as well as the two-year data therefrom, Vera's plans to meet with, and submit a BLA for atacicept to, the FDA, and to potentially receive FDA approval for atacicept in IgAN and launch it commercially, and, in each case, the timing thereof, the potential for atacicept to bring value for patients and to the change the standard of care in IgAN, if approved, and other statements that are not historical fact. Because such statements are subject to risk and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as 'anticipate,' 'believe,' 'expect,' 'plan,' 'potential' and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Vera's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks related to the regulatory approval process, results of earlier clinical trials may not be obtained in later clinical trials, preliminary or interim results may not be predictive of final study results, risks and uncertainties associated with Vera's business in general, the impact of macroeconomic and geopolitical events, and the other risks described in Vera's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. Vera undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. For more information, please contact: Investor Contact:Joyce AllaireLifeSci Advisors212-915-2569jallaire@ Media Contact:Debra CharlesworthVera Therapeutics415-854-8051corporatecommunications@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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Vera Therapeutics Announces Atacicept Achieved 46% Proteinuria Reduction in ORIGIN Phase 3 Trial in Adults with IgA Nephropathy
Atacicept ORIGIN Phase 3 trial met the primary endpoint of reduction in proteinuria (UPCR) at week 36; participants receiving atacicept achieved a 46% reduction from baseline and 42% reduction compared to placebo at week 36 (p<0.0001) Other prespecified endpoints achieved similar or better results compared to the ORIGIN Phase 2b clinical trial — per FDA guidance, Vera is not sharing eGFR results at this time while the ORIGIN 3 placebo-controlled trial continues The safety profile of atacicept was favorable, and comparable to placebo Vera plans to meet with FDA in the coming weeks to discuss these results and the regulatory pathway; Vera currently plans to submit a Biologics License Application (BLA) for accelerated approval to the FDA in 4Q 2025; ORIGIN 3 trial continues with two-year results expected in 2027 Vera will host a conference call and webcast at 8:00 am ET on Monday, June 2 BRISBANE, Calif., June 02, 2025 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA) today announced that the primary endpoint was met in the ORIGIN Phase 3 trial of atacicept for the treatment of immunoglobulin A nephropathy (IgAN) in adults. Participants treated with atacicept achieved a 46% reduction from baseline in proteinuria as measured by 24-hour urine protein-to-creatinine ratio (UPCR), with a statistically significant and clinically meaningful 42% reduction in UPCR compared to placebo (p<0.0001) at week 36. For other prespecified endpoints, atacicept treatment also demonstrated results that were consistent with or better than those previously observed in the ORIGIN Phase 2b trial.1 The safety profile of atacicept in this analysis was favorable, and comparable to placebo. Vera plans to share these results with the FDA in the coming weeks, and full results will be submitted to the American Society of Nephrology Kidney Week. 'ORIGIN 3 is the first Phase 3 clinical trial in IgAN to demonstrate this magnitude of UPCR reduction compared to placebo at week 36. These results convincingly demonstrate the impact of atacicept to reduce proteinuria,' said Richard Lafayette, M.D., F.A.C.P., Professor of Medicine, Nephrology and Director of the Glomerular Disease Center at Stanford University Medical Center, and a primary investigator for both ORIGIN 2b and ORIGIN 3. 'If approved, we believe that atacicept has the potential to advance the standard of care in IgAN as the first dual BAFF/APRIL inhibitor. We currently plan to submit a BLA for atacicept in IgAN to the FDA in the fourth quarter of this year, which may allow for US approval and commercial launch in 2026. We are grateful to the study participants, their families and caregivers, the study investigators and staff, our research partners, and the Vera team for their ongoing commitment and dedication to this important research,' said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. 'Vera aspires to evolve the practice of kidney medicine with the hope that, one day, patients may no longer face a future of dialysis or transplantation. Vera is poised for potential commercial launch of atacicept in 2026 and to pursue development in additional indications in other autoimmune kidney diseases and beyond.' 'Patients with IgA nephropathy, as well as their families and care partners, suffer from clinical uncertainty and the horrible outcome of kidney failure. In addition to clinical signs and symptoms, IgAN has a devastating impact on quality of life and mental wellbeing. I'm thrilled with the progress that is being made in developing new treatments for patients,' said Bonnie Schneider, Director and Cofounder of the IgA Nephropathy Foundation. ORIGIN 3 is an ongoing global, multicenter, randomized, double-blind, placebo-controlled Phase 3 trial of 431 adults with IgA nephropathy. Participants were randomized 1:1 to atacicept 150 mg, self-administered at home via once weekly subcutaneous injection, or placebo. The primary efficacy endpoint was the change in 24-hour UPCR compared to placebo at the 36-week interim analysis. The trial continues in a placebo-controlled blinded manner to evaluate the change in kidney function over two years as measured by eGFR and is expected to complete in 2027. For more information about the ORIGIN 3 clinical trial (NCT04716231), please visit The Company will host an investor call and webcast to discuss the data update at 8:00 AM ET on Monday, June 2. Investors Dial-in: 1-877-425-9470 Int'l Investors Dial-in: 1-201-389-0878 Conference ID: 13754147 Webcast: The live webcast will be available on the Company's Investor Calendar, with the recording and presentation available immediately following the event. References1. Barratt J, et al. JASN 2024 About Atacicept Atacicept is an investigational recombinant fusion protein that contains the soluble transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor that binds to the cytokines B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL). These cytokines are members of the tumor necrosis factor family that promote B-cell survival and autoantibody production associated with certain autoimmune diseases, including IgAN, other autoimmune kidney diseases and lupus nephritis. The ORIGIN Phase 2b clinical trial of atacicept in IgAN met its primary and key secondary endpoints, with statistically significant and clinically meaningful proteinuria reductions and stabilization of eGFR versus placebo through 36 weeks. The safety profile during the randomized period was comparable between atacicept and placebo. Through 96 weeks, atacicept demonstrated further improvements in Gd-IgA1, hematuria, and proteinuria, as well as stabilization of eGFR reflecting a profile consistent with that of the general population without IgAN. Atacicept has received FDA Breakthrough Therapy Designation for the treatment of IgAN, which reflects the FDA's determination that, based on an assessment of data from the ORIGIN Phase 2b clinical trial, atacicept may demonstrate substantial improvement on a clinically significant endpoint over available therapies for patients with IgAN. Vera believes atacicept is positioned for best-in-class potential, targeting B cells to reduce autoantibodies and having been administered to more than 1,500 patients in clinical trials across different indications. About VeraVera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera's mission is to advance treatments that target the source of immunological diseases in order to change the standard of care for patients. Vera's lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both BAFF and APRIL, which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgAN and lupus nephritis. In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful. Vera also holds an exclusive license agreement with Stanford University for a novel, next generation fusion protein targeting BAFF and APRIL, known as VT-109, with wide therapeutic potential across the spectrum of B cell mediated diseases. Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK virus (BKV), a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. Vera retains all global developmental and commercial rights to atacicept and MAU868. For more information, please visit Forward-looking StatementsStatements contained in this press release regarding matters, events or results that may occur in the future are 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, atacicept's potential to be a best-in-class therapy for patients with IgAN, atacicept's potential as a treatment for indications beyond IgAN, Vera's expectations concerning other predefined endpoints in the Phase 3 ORIGIN trial, as well as the two-year data therefrom, Vera's plans to meet with, and submit a BLA for atacicept to, the FDA, and to potentially receive FDA approval for atacicept in IgAN and launch it commercially, and, in each case, the timing thereof, the potential for atacicept to bring value for patients and to the change the standard of care in IgAN, if approved, and other statements that are not historical fact. Because such statements are subject to risk and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as 'anticipate,' 'believe,' 'expect,' 'plan,' 'potential' and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Vera's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks related to the regulatory approval process, results of earlier clinical trials may not be obtained in later clinical trials, preliminary or interim results may not be predictive of final study results, risks and uncertainties associated with Vera's business in general, the impact of macroeconomic and geopolitical events, and the other risks described in Vera's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. Vera undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. For more information, please contact: Investor Contact:Joyce AllaireLifeSci Advisors212-915-2569jallaire@ Media Contact:Debra CharlesworthVera Therapeutics415-854-8051corporatecommunications@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
