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Yahoo
12-05-2025
- Business
- Yahoo
Atea Pharmaceuticals Reports First Quarter 2025 Financial Results and Provides Business Update
Enrollment Ongoing in Phase 3 C-BEYOND Trial for Treatment of HCV Full Phase 2 Results for Regimen of Bemnifosbuvir and Ruzasvir for HCV and Results from Three Additional Phase 1 Studies Supporting Potential Best-in-Class Profile Presented at European Association for the Study of the Liver (EASL) Congress 2025 Virtual Investor Event with Key Opinion Leader Insights on HCV to be Held May 14, 2025, at 10:00 AM ET BOSTON, May 12, 2025 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (Atea or Company), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today reported financial results for the first quarter ended March 31, 2025 and provided a business update. The Company's combination regimen of bemnifosbuvir (BEM), a nucleotide analog polymerase inhibitor, and ruzasvir (RZR), an NS5A inhibitor, is in Phase 3 development for the treatment of hepatitis C virus (HCV). 'Atea has made very significant progress thus far in 2025, initiating and continuing to enroll patients in C-BEYOND, our Phase 3 clinical trial evaluating the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV in the US and Canada,' said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea. 'We are also focused on initiating our second Phase 3 trial, C-FORWARD, which will be conducted at clinical sites outside of North America. We expect enrollment of patients in C-FORWARD to begin mid-year.' "We are very encouraged by the positive results of the Phase 2 clinical study and additional data presented at EASL 2025 supporting the efficacy, safety and potential best-in-class profile of our regimen of bemnifosbuvir and ruzasvir, including short treatment duration, low risk for drug-drug interactions, and convenience with no food effect,' continued Dr. Sommadossi. 'We believe our regimen, if approved, has the potential to increase the number of treated and cured HCV patients and to disrupt the global HCV market of approximately $3 billion in net sales." HCV KOL Investor Event to be Held May 14, 2025 at 10:00 AM ET Atea will host a virtual key opinion leader (KOL) investor event with a panel of HCV experts and prescribers on Wednesday, May 14, 2025, at 10:00 AM ET. To register, click here. This KOL event will replace Atea's first quarter 2025 earnings conference call, and Quarterly calls will resume with the second quarter 2025 financial results. This investor event will include an expert panel of several leaders in hepatology, gastroenterology, infectious diseases, and HCV treatments in the US, Canada and Europe. These experts and prescribers will discuss the current challenges experienced by people living with HCV, the full results of Atea's global Phase 2 study evaluating the regimen of BEM/RZR for the treatment of HCV, and what a new optimized HCV therapy could provide for prescribers and patients. Company management will discuss the HCV commercial market opportunity and the ongoing global Phase 3 clinical development. Summary of Results Presented at EASL Poster Title: Efficacy and Safety of Bemnifosbuvir and Ruzasvir after 8 Weeks of Treatment in Patients with Chronic Hepatitis C Virus (HCV) Infection (TOP-251)Conclusion: The Phase 2 study results demonstrated that an 8-week combination regimen of BEM (550 mg) and RZR (180 mg) achieved SVR12 in 98% of treatment-adherent patients and 95% of patients regardless of treatment adherence. The regimen was safe and well-tolerated with low rates of virologic failure and no study-drug-related serious adverse events or treatment discontinuations. Treatment emergent adverse events (TEAEs) were reported in 43% (118/275) of patients. Most TEAEs were mild to moderate in intensity, with headache (9%) and nausea (8%) being the most reported. These results reinforce the potential of the combination regimen of BEM and RZR as a best-in-class treatment for Title: Pharmacokinetics of Bemnifosbuvir in Participants with Hepatic Impairment (WED-278)Conclusion: A Phase 1 pharmacokinetic study evaluating a single 550 mg dose of BEM in participants with varying degrees of hepatic impairment showed increased drug exposure in individuals with moderate to severe liver dysfunction. However, these changes did not meaningfully affect levels of AT-273, the plasma marker for the active intracellular antiviral metabolite of BEM. No safety concerns were identified. These results support the use of BEM without dose adjustment in patients with hepatic impairment. Poster Title: No DDI Between Bemnifosbuvir/Ruzasvir and Bictegravir/Emtricitabine/Tenofovir Alafenamide (WED-279)Conclusion: Findings from a Phase 1 drug-drug interaction study in healthy participants demonstrated that co-administration of BEM/RZR with the standard human immunodeficiency virus (HIV) regimen bictegravir/emtricitabine/tenofovir alafenamide (B/FTC/TAF) resulted in no clinically significant pharmacokinetic changes. The co-administered HCV/HIV combinations were generally safe and well tolerated. These results support the future inclusion of HCV/HIV co-infected patients receiving these HIV therapies in the Phase 3 clinical development program for BEM/RZR. It is estimated that in the US as many as 6 to 30% of HCV patients are co-infected with HIV.1 Poster Title: Pharmacokinetics of Bemnifosbuvir in Participants with Renal Impairment (WED-280)Conclusion: A Phase 1 renal impairment study showed that a single 550 mg dose of BEM was safe and well-tolerated across participants with normal kidney function, moderate-to-severe renal impairment, and those with end-stage renal disease on hemodialysis. While the circulating inactive nucleoside metabolites of BEM increased as expected in renally impaired individuals, exposure of BEM remained consistent. These findings suggest that BEM may be used without dose adjustment in patients with renal dysfunction, including those undergoing dialysis. About the Bemnifosbuvir / Ruzasvir HCV Phase 3 Program Atea's HCV Phase 3 program includes two open-label Phase 3 trials, C-BEYOND in the US and Canada, and C-FORWARD, a global trial outside of North America. Each Phase 3 trial will enroll approximately 880 treatment-naïve patients, including those with and without compensated cirrhosis. The trials will compare the fixed-dose combination (FDC) regimen of BEM/RZR to the FDC regimen of sofosbuvir and velpatasvir. The regimen of BEM/RZR will be administered orally once-daily for eight weeks (in patients without cirrhosis) or 12 weeks (in patients with compensated cirrhosis) while the regimen of sofosbuvir and velpatasvir will be administered orally once-daily for 12 weeks to all patients, with or without compensated cirrhosis. The primary endpoint for each trial is HCV RNA < lower limit of quantitation (LLOQ) at 24 weeks from the start of treatment and encompasses sustained virologic response 12 weeks post-treatment (SVR12) in each arm. Measurement at 24 weeks from the start of treatment is to ensure the primary endpoint occurs at the same relative timepoint from the start of treatment in all patients. Patient enrollment in the C-BEYOND trial is ongoing and enrollment in the C-FORWARD trial is expected to begin in mid-2025. The initiation of the Phase 3 program follows a successful engagement with the US Food and Drug Administration (FDA) at an End-of-Phase 2 meeting in January 2025, shortly after the Company announced the topline results from the Phase 2 study evaluating the potential best-in-class regimen of BEM/RZR, including data demonstrating that the regimen met its primary endpoints of efficacy (SVR12) and safety. Business and Organizational Updates In December 2024, Atea engaged Evercore, a global independent investment bank, to identify potential opportunities to enhance shareholder value. The process includes a review of a broad range of strategic alternatives, including strategic partnerships, acquisition, merger, or other business combination, sale of assets or other strategic transactions. The process is ongoing, and the Company continues to evaluate all options to maximize shareholder value. In the first quarter 2025, to enhance efficiency in the management of infrastructure expenditures, Atea reduced its workforce by approximately 25%. This workforce reduction is expected to result in cost savings of approximately $15 million through 2027. In February 2025, Arthur S. Kirsch was appointed to the Company's Board of Directors. Mr. Kirsch has extensive knowledge of the healthcare and life sciences industries gained from decades of investment banking and capital markets experience as well as extensive public board and strategic experience. In April 2025, Atea further refreshed its Board of Directors with the appointment of Howard H. Berman, PhD. The appointment of Dr. Berman, who is currently serving as an observer, will become effective upon the completion of Atea's 2025 Annual Meeting of Stockholders. Dr. Berman has over 20 years of entrepreneurial and life science industry experience working at the interplay of science and business. In April 2025, Atea announced that its Board had authorized the repurchase of up to $25 million of the Company's common stock. This authorization reflects the Company's commitment to return capital to shareholders, while maintaining the capacity to complete its global Phase 3 HCV program and position Atea for long-term success. First Quarter 2025 Financial Results Cash, Cash Equivalents and Marketable Securities: $425.4 million at March 31, 2025, compared to $454.7 million at December 31, 2024. Research and Development Expenses: Research and development expenses decreased by $28.0 million from $57.6 million for the three months ended March 31, 2024, to $29.6 million for the three months ended March 31, 2025. The net decrease was primarily driven by lower external spend as Atea's COVID-19 Phase 3 SUNRISE-3 clinical trial was completed in 2024. The decrease was offset by an increase in external spend principally related to startup activities for the Company's HCV Phase 3 clinical development. Additionally, a decrease in internal research and development expenses was primarily related to lower stock-based compensation expense in the three-month period ended March 31, 2025. General and Administrative Expenses: General and administrative expenses decreased by $2.8 million from $12.2 million for the three months ended March 31, 2024, to $9.5 million for the three months ended March 31, 2025. The net decrease was primarily related to lower stock-based compensation expense, partially offset by increased professional Income and Other, Net: Interest income and other, net, decreased by $1.9 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024, primarily due to lower investment balances. Income Taxes: Income tax expense was $0.2 million for the three months ended March 31, 2025, and March 31, 2024. Condensed Consolidated Statement of Operations and Comprehensive Loss(in thousands, except share and per share amounts)(unaudited) Three Months EndedMarch 31, 2025 2024 Operating expenses Research and development $ 29,584 $ 57,575 General and administrative 9,457 12,231 Total operating expenses 39,041 69,806 Loss from operations (39,041 ) (69,806 ) Interest income and other, net 4,972 6,868 Loss before income taxes (34,069 ) (62,938 ) Income tax expense (203 ) (231 ) Net loss $ (34,272 ) $ (63,169 ) Other comprehensive loss Unrealized loss on available-for-sale investments (115 ) (388 ) Comprehensive loss $ (34,387 ) $ (63,557 ) Net loss per share - basic and diluted $ (0.40 ) $ (0.75 ) Weighted-average number of common shares - basic and diluted 85,159,254 83,916,193 Selected Condensed Consolidated Balance Sheet Data(in thousands)(unaudited) March 31, 2025 December 31, 2024 Cash, cash equivalents and marketable securities $ 425,436 $ 454,721 Working capital(1) 411,961 443,752 Total assets 439,964 464,668 Total liabilities 28,880 25,801 Total stockholder's equity 411,084 438,867 (1 ) Atea defines working capital as current assets less current liabilities. See the Company's condensed consolidated financial statements in its Quarterly Report on Form 10-Q for the three months ended March 31, 2025, for further detail regarding its current assets and liabilities. About HCV HCV is a blood-borne, positive-sense, single-stranded (ss) RNA virus that primarily infects liver cells. HCV is a leading cause of chronic liver disease and liver transplants, spreading via blood transfusion, hemodialysis and needle sticks, with approximately 240,000 deaths occurring each year. Despite the availability of direct-acting antivirals, HCV continues to be a significant global healthcare issue. An estimated 50 million people worldwide are chronically infected with HCV and there are approximately one million new infections each year. In the US, between 2.4 and 4 million people are estimated to have HCV with annual new infections outpacing treatment rates. HCV infections in the US predominate in patients in the age group between 20-49 years old, and it is estimated that less than 10% of HCV-infected patients in the US have cirrhosis. Chronic HCV infection is the leading cause of liver cancer in the US, Europe and Japan. About Atea Pharmaceuticals Atea is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral antiviral therapies to address the unmet medical needs of patients with serious viral infections. Leveraging Atea's deep understanding of antiviral drug development, nucleos(t)ide chemistry, biology, biochemistry and virology, Atea has built a proprietary nucleos(t)ide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of serious viral diseases. Atea plans to continue to build its pipeline of antiviral product candidates by augmenting its nucleos(t)ide platform with other classes of antivirals that may be used in combination with its nucleos(t)ide product candidates. Atea's lead program and current focus is on the development of the combination of bemnifosbuvir, a nucleotide analog polymerase inhibitor, and ruzasvir, an NS5A inhibitor, to treat HCV. For more information, please visit Forward-Looking Statements This press release includes 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include but are not limited to statements regarding the potential best-in-class profile of the regimen of BEM and RZR for the treatment of HCV, the potential opportunity created by the regimen to increase the number of patients treated and cured, the opportunity to disrupt the global HCV market, the expected time of commencement of enrollment in the C-FORWARD Phase 3 clinical trial, future results of operations and financial position, business strategy, anticipated milestone events and timelines for clinical trials, benefits of cost savings initiatives, repurchases under the Company's share repurchase program, the timing and outcome of the Company's strategic alternatives review, the timing and agenda of the Company's KOL event and the Company's plans to resume Quarterly earnings calls in the second quarter of 2025. When used herein, words including 'expected,' 'should,' 'anticipated,' 'believe.' 'will,' 'plans', and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Atea's current expectations and various assumptions. Atea believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Atea may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, uncertainties inherent in the drug discovery and development process and the regulatory submission or approval process, unexpected or unfavorable safety or efficacy data or results observed during clinical trials or in data readouts; delays in or disruptions to clinical trials or our business; our reliance on third parties over which we may not always have full control, our ability to manufacture sufficient commercial product, competition from approved treatments for HCV, the timeline for the completion of the strategic alternatives review process is unknown and there can be no assurance that the process will result in any particular outcome; dependence on the success of Atea's most advanced product candidates, in particular the combination of BEM and RZR for the treatment of HCV; as well as the other important factors discussed under the caption 'Risk Factors' in Atea's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025 as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC's website at These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While Atea may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing Atea's views as of any date subsequent to the date of this press release. Contacts Jonae BarnesSVP, Investor Relations and Corporate Joyce AllaireLifeSci Advisorsjallaire@ 1
Business Insider
11-05-2025
- Business
- Business Insider
Akero Therapeutics announces new analyses of Phase 2b HARMONY trial
Akero Therapeutics (AKRO) announced results from new analyses of the 96-week Phase 2b HARMONY trial of efruxifermin, EFX, in patients with pre-cirrhotic metabolic dysfunction-associated steatohepatitis, MASH, in an oral presentation and a poster presentation at the European Association for the Study of the Liver, EASL, Congress 2025 taking place May 7-10, in Amsterdam, the Netherlands. The presentations corroborate the antifibrotic activity previously reported by conventional pathology for EFX in patients with pre-cirrhotic MASH. Specifically, among patients treated with EFX, digital pathology analysis by HistoIndex's AI-based qFibrosis showed concordance at the individual level with two non-invasive tests of liver fibrosis-ELF test score and liver stiffness measurement-with more than half of patients treated with 50mg EFX classified as responders by all three endpoints compared to fewer than 5% of placebo patients. Protect Your Portfolio Against Market Uncertainty
Business Wire
09-05-2025
- Business
- Business Wire
Vir Biotechnology Announces Preliminary 24-Week Post-End of Treatment Data for Tobevibart and Elebsiran Combinations in Chronic Hepatitis B From the MARCH Study
SAN FRANCISCO--(BUSINESS WIRE)--Vir Biotechnology, Inc. (Nasdaq: VIR) today announced 24-week post-end of treatment data from Part B of the ongoing MARCH Phase 2 clinical study evaluating tobevibart and elebsiran without or with pegylated interferon alpha (PEG-IFNα) in participants with chronic hepatitis B (CHB). The study-defined primary endpoint, proportion of participants with undetectable hepatitis B surface antigen (HBsAg) at 24 weeks post-end of treatment, was achieved by 17% (3/18) and 21% (3/14) of participants with baseline HBsAg<1,000 IU/mL receiving tobevibart and elebsiran without or with PEG-IFNα, respectively. The detailed data were presented today at the European Association for the Study of the Liver (EASL) congress in Amsterdam (The Netherlands). CHB is a long-lasting, inflammatory liver disease caused by the hepatitis B virus (HBV). 1 The World Health Organization estimates that 254 million people live with CHB, and an estimated 1.1 million yearly deaths are associated with the disease. 2 Complications from CHB may include liver cirrhosis, liver failure and liver cancer. 3 Although CHB can be treated, there is currently no cure. 1 Participants in the trial received tobevibart and elebsiran without or with PEG-IFNα. Tobevibart was administered at 300 mg every 4 weeks; elebsiran, at 200 mg every 4 weeks; and PEG-IFNα, for patients receiving it, at 180 µg weekly. Participants with HBsAg loss (seroclearance) after 48 weeks of treatment who met eligibility criteria discontinued both NRTI (nucleos(t)ide reverse transcriptase inhibitor) as well as tobevibart and elebsiran without or with PEG-IFNα treatment. The current analysis includes data from participants in the trial who have reached Week 24 post-end of treatment: 51 participants receiving tobevibart and elebsiran without PEG-IFNα and 32 receiving tobevibart and elebsiran with PEG-IFNα. An additional 18 participants receiving tobevibart and elebsiran with PEG-IFNα are currently advancing through the trial. Study-defined primary efficacy endpoint – The study-defined primary efficacy endpoint is proportion of participants with HBsAg seroclearance (defined as undetectable HBsAg) at 24 weeks post-end of treatment. Tobevibart and elebsiran without or with PEG-IFNα resulted in HBsAg loss 24 weeks post-end of treatment in 17% (3/18) and 21% (3/14) of participants with baseline HBsAg<1,000 IU/mL, respectively. These proportions were 8% (4/51) and 16% (5/32) for tobevibart and elebsiran without or with PEG-IFNα, respectively, in all participants. Functional cure – Functional cure is defined as sustained undetectable HBsAg and HBV DNA below the lower limit of quantification (0.05 IU/mL) at 24 weeks post-end of treatment after discontinuing NRTIs. Tobevibart and elebsiran without or with PEG-IFNα resulted in functional cure in 11% (2/18) and 15% (2/13) of participants with HBsAg<1000 IU/mL, respectively. These proportions were 4% (2/51) and 10% (3/30) for the combinations without or with PEG-IFNα, respectively, in all participants. Modified functional cure (allowing viral blips) – An exploratory modified functional cure, allowing transient viremia (viral blips) defined as HBV RNA or HBsAg equal or above the lower limit of quantification for ≤35 days, was also evaluated. Tobevibart and elebsiran without or with PEG-IFNα resulted in 24 weeks post-end of treatment modified functional cure rates of 11% (2/18) and 23% (3/13) in participants with HBsAg<1000 IU/mL, respectively. These proportions were 6% (3/51) and 13% (4/30) for the combinations without or with PEG-IFNα, respectively, in all participants. The safety and tolerability profile of tobevibart and elebsiran is consistent with prior studies. The data show that the combination is well tolerated, with no new safety concerns and generally only mild or moderate treatment emergent adverse events being reported throughout the study. "The MARCH data demonstrate that combinations of tobevibart and elebsiran can achieve and maintain HBsAg loss in a subset of participants with low baseline HBsAg levels,' said Mark Eisner, M.D., MPH, Chief Medical Officer, Vir Biotechnology. 'These findings provide important insights into the challenges of achieving functional cure in chronic hepatitis B and will inform future development efforts in the field.' As previously communicated, Phase 3 development of combinations of tobevibart and elebsiran in CHB will not move forward without a global development and commercialization partner, which has not been secured. The Company plans to streamline the final stages of the MARCH Phase 2 program to ensure continued participant benefit and safety, while applying continued financial stewardship. Cash runway guidance into mid-2027 remains unchanged, based on the current operating plan. Vir Biotechnology is fully committed to the continued development of tobevibart and elebsiran in chronic hepatitis delta, based on the transformational potential of the first-of-its-kind investigational combination to achieve complete suppression of the hepatitis delta virus, as shown by compelling positive efficacy and safety data from the Phase 2 SOLSTICE clinical trial. About Tobevibart and Elebsiran Tobevibart is an investigational broadly neutralizing monoclonal antibody targeting the hepatitis B surface antigen (HBsAg). It is designed to inhibit the entry of hepatitis B and hepatitis delta viruses into hepatocytes and to reduce the level of circulating viral and subviral particles in the blood. Tobevibart was identified using Vir Biotechnology's proprietary monoclonal antibody discovery platform. The Fc domain has been engineered to increase immune engagement and clearance of HBsAg immune complexes and incorporates Xencor's Xtend™ technology to extend half-life. Tobevibart is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis delta. Elebsiran is an investigational hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) discovered by Alnylam Pharmaceuticals, Inc. It is designed to degrade hepatitis B virus RNA transcripts and limit the production of hepatitis B surface antigen. Current data indicates that it has the potential to have direct antiviral activity against hepatitis B virus and hepatitis delta virus. Elebsiran is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis delta. About Vir Biotechnology, Inc. Vir Biotechnology, Inc., is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies. Vir Biotechnology routinely posts information that may be important to investors on its website. References: Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as 'should,' 'could,' 'may,' 'might,' 'will,' 'plan,' 'potential,' 'aim,' 'expect,' 'anticipate,' 'promising' and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements regarding: the therapeutic potential of the combination of tobevibart and elebsiran to treat chronic hepatitis B and chronic hepatitis delta; Vir Biotechnology's commitment to the continued development of the combination of tobevibart and elebsiran in chronic hepatitis delta and the transformational potential of the combination to achieve complete hepatitis delta viral suppression in a majority of patients; Vir Biotechnology's anticipated cash runway; Vir Biotechnology's strategy and plans; and any assumptions underlying any of the foregoing. Many factors may cause differences between current expectations and actual results, including, without limitation: unexpected safety or efficacy data or results observed during clinical studies or in data readouts, including the occurrence of adverse safety events; risks of unexpected costs, delays or other unexpected hurdles; challenges in accessing manufacturing capacity; clinical site activation rates or clinical enrollment rates that are lower than expected; the timing and outcome of Vir Biotechnology's planned interactions with regulatory authorities, as well as general difficulties in obtaining any necessary regulatory approvals; successful development and/or commercialization of alternative product candidates by Vir Biotechnology's competitors, as well as changes in expected or existing competition; geopolitical changes or other external factors; and unexpected litigation or other disputes. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. The actual results may vary from the anticipated results, and the variations may be material. You are cautioned not to place undue reliance on any scientific data presented or these forward-looking statements, which are based on Vir Biotechnology's available information, expectations and assumptions as of the date of this press release. Other factors that may cause Vir Biotechnology's actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir Biotechnology's filings with the U.S. Securities and Exchange Commission, including the section titled 'Risk Factors' contained therein. Except as required by law, Vir Biotechnology assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Hamilton Spectator
07-05-2025
- Health
- Hamilton Spectator
Late-breaking exploratory data highlights the impact of IQIRVO® (elafibranor) on fatigue and provides mechanistic insights into anti-inflammatory and symptom-related effects in patients with primary biliary cholangitis
PARIS, FRANCE, 7 May 2025 Today, Ipsen (Euronext: IPN; ADR: IPSEY) announced new data from two late-breaking presentations on IQIRVO ® (elafibranor) during the European Association for the Study of the Liver congress. Additional analyses from the ELATIVE ® study (LBP-027) suggest that patients with primary biliary cholangitis (PBC) treated with IQIRVO had greater improvements in fatigue compared to placebo after 52 weeks, as measured by both the PROMIS Fatigue Short Form 7a questionnaire (42.9% IQIRVO versus 31.3% placebo) and PBC-40 fatigue domain (22.6% IQIRVO versus 15.4% placebo). Among patients with moderate-to-severe fatigue at baseline, more than twice as many patients treated with IQIRVO (66.7%) achieved clinically meaningful improvements compared to placebo (31.3%). Importantly, the data suggest that the positive effect of IQIRVO on fatigue occurs independently of its effect on pruritus. 1 'For so many patients living with PBC, fatigue is a debilitating symptom that can impact their ability to perform daily tasks or participate in social activities,' said Dr David Jones, Professor of Liver Immunology for the Faculty of Medical Science at Newcastle University. 'As a physician treating people with PBC, these new data are providing important insights into how the action of IQIRVO could impact fatigue.' These findings are supported by additional late-breaking exploratory data (LBP-025) from a comprehensive proteomic analysis with longitudinal samples from patients in ELATIVE ® evaluated using Olink ® technology covering more than 5,500 proteins. Over 20 proteins involved in disease biology mapping to pathways involved in inflammation and immune response, bile acids and lipid homeostasis, fibrosis, and key PBC symptomatic domains, including pruritus and fatigue, had changes in expression in patients treated with IQIRVO with biochemical response at Week 52. Effects observed on fatigue-associated proteomic signatures appeared to be associated with PPARα activation. 2 'These mechanistic data reinforce the value of IQIRVO as an important treatment option for people with PBC,' said Sandra Silvestri, MD, EVP and Chief Medical Officer, Ipsen. 'Today, we have a clearer understanding of the molecular action of PBC. We believe the more we learn about a disease, the more effective we can be in developing treatments for patients that address both the disease and debilitating symptoms.' PBC is a rare, autoimmune liver disease where a build-up of bile and toxins and chronic inflammation causes irreversible fibrosis of the liver and destruction of the bile ducts. Impacting approximately 100,000 people in the US and 165,000 people in Europe, the majority being women, PBC is a lifelong condition that can worsen over time if not effectively treated and may lead to liver transplant and in some cases, premature death. About IQIRVO® (elafibranor) IQIRVO (pronounced EYE-KER-VO) is an oral, once-daily, peroxisome proliferator-activated receptor (PPAR) agonist, which exerts an effect on PPARα and PPARδ. Activation of PPARα and PPARδ decreases bile toxicity and improves cholestasis by modulating bile acid synthesis, detoxification and transporters. Activation of PPARα and PPARδ also has anti-inflammatory effects by acting on different pathways. In 2019, IQIRVO was granted Breakthrough Therapy Designation by the U.S Food and Drug Administration (FDA) in adults with PBC who have an inadequate response to ursodeoxycholic acid (UDCA) the existing first-line therapy for PBC. IQIRVO was granted U.S. FDA accelerated approval in June 2024, EU conditional approval by the European Commission (EC) in September 2024 and UK Medicines and Healthcare products Regulatory Agency (MHRA) approval in October 2024, for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. The FDA, EC and MHRA approvals are contingent on the further verification of clinical benefit. IQIRVO is currently in regulatory processes with other authorities. IQIRVO (elafibranor) was developed by GENFIT. Ipsen licensed the exclusive worldwide rights (except China, Hong Kong, Taiwan and Macau) to elafibranor from GENFIT in 2021. About ELATIVE ELATIVE is a multi-center, randomized, double-blind, placebo-controlled Phase III clinical trial, with an open-label long-term extension (NCT04526665). ELATIVE is evaluating the efficacy and safety of elafibranor 80mg once daily versus placebo for the treatment of patients with PBC with an inadequate response or intolerance to ursodeoxycholic acid (UDCA), the existing first-line therapy for PBC. The trial enrolled 161 patients who were randomized 2:1 to receive elafibranor 80mg once daily or placebo. Patients with an inadequate response to UDCA would continue to receive UDCA in combination with elafibranor or placebo, while patients unable to tolerate UDCA would receive only elafibranor or placebo. Patients continued their assigned treatment after Week 52 until all patients had completed their treatment or for a maximum of 104 weeks. The open-label long-term extension of ELATIVE remains ongoing. ENDS About Ipsen We are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Our pipeline is fueled by external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in more than 80 countries. Ipsen is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit . Ipsen contacts Investors Media Disclaimers and/or Forward-Looking Statements The forward-looking statements, objectives and targets contained herein are based on Ipsen's management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect Ipsen's future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words 'believes', 'anticipates' and 'expects' and similar expressions are intended to identify forward-looking statements, including Ipsen's expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account external-growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by Ipsen. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. 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Business Wire
28-04-2025
- Health
- Business Wire
Boston Pharmaceuticals to Present the Effect of Efimosfermin Alfa on Collagen Biomarkers in Patients with F2 and F3 MASH at EASL Congress 2025
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Boston Pharmaceuticals, a clinical-stage biopharmaceutical company developing efimosfermin alfa, a once-monthly FGF21 analogue for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), today announced it will present results from an analysis of its Phase 2 study in participants with stage F2 and F3 fibrosis due to MASH. The findings will be presented at the European Association for the Study of the Liver (EASL) Congress 2025, May 7-10, in Amsterdam. "In the analysis, efimosfermin demonstrated improvements in biomarkers related to collagen and a reduction in liver scarring among patients with moderate to advanced liver fibrosis (stages F2-F3) caused by metabolic dysfunction-associated steatotic liver disease," said Rohit Loomba, M.D., MHSc, Professor of Medicine and Chief of the Division of Gastroenterology and Hepatology at University of California, San Diego. 'These data support the histology findings that efimosfermin may have promising effects in treating liver fibrosis in individuals with metabolic liver disease.' As fibrosis progresses, the risk of liver-related morbidity and mortality increases in patients with MASH. This is associated with an imbalance in extracellular matrix (ECM) synthesis and degradation, leading to collagen accumulation in the liver. Improvements in collagen biomarkers over 24 weeks suggest that efimosfermin reduces fibrotic activity, shifting the balance from fibrogenesis to fibrolysis. These results are consistent with histopathology findings presented at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting ® in November 2024, which showed that treatment with once-monthly efimosfermin led to significant improvements in fibrosis ≥1 stage without worsening of MASH, and MASH resolution without worsening of fibrosis, compared to placebo over 24 weeks in participants with biopsy-confirmed F2/F3 MASH. Substantial and rapid improvements in cardiometabolic benefits, such as liver fat reduction and improved glycemic control, were also observed in MASH patients with obesity and diabetes. Efimosfermin was generally well tolerated in the Phase 2 study, with low discontinuation rates due to adverse events, and an overall low incidence of gastrointestinal side effects and injection site reactions. 'We are seeing clear and meaningful improvements in key cardiometabolic and liver biomarkers, as well as a reduction in fibrosis, which is critical for MASH patients,' said Sophie Kornowski, CEO of Boston Pharmaceuticals. 'The continued positive data from our Phase 2 trial reinforces the promise of once-monthly efimosfermin as a transformative therapy for patients with MASH. We are encouraged by the strength of treatment response and the favorable safety profile observed in this trial, which positions us well for upcoming regulatory meetings. Our commitment to developing efimosfermin remains steadfast, and we are excited for the next steps in our journey to improve the lives of those living with this disease.' Details of Boston Pharmaceuticals' presentation at EASL Congress 2025 are as follows: About MASH Metabolic dysfunction-associated steatohepatitis (MASH), formerly known as non-alcoholic steatohepatitis (NASH), is a growing global epidemic fueled by the increasing prevalence of obesity and type 2 diabetes. It is estimated that MASH affects millions of people worldwide, including 17 million in the U.S., and is expected to increase by 63% by 2030. MASH is a progressive disease staged by the degree of fibrosis (scarring) in the liver and is closely associated with multiple cardiometabolic risk factors. Left untreated, MASH could lead to liver failure, liver cancer, or death. In the U.S., MASH is becoming the leading cause of liver transplantation. About efimosfermin alfa Boston Pharmaceuticals' lead investigational agent, efimosfermin alfa, is a once-monthly subcutaneous injection of a long-acting variant of human fibroblast growth factor 21 (FGF21) that regulates various metabolic pathways to decrease liver fat, ameliorate liver inflammation, and reverse liver fibrosis in patients with MASH. Efimosfermin is manufactured in mammalian cells, leading to human-like glycosylation. Efimosfermin is currently in Phase 2 clinical trials for the treatment of MASH. In a 24-week Phase 2 study of subjects with moderate to advanced (stage F2 and F3) fibrosis due to MASH, efimosfermin has demonstrated statistically significant improvements in liver fibrosis and MASH resolution, reductions in liver fat content, improved markers of liver injury and metabolic biomarkers, with a favorable safety profile. The most frequently reported treatment-emergent adverse events were gastrointestinal events and were predominantly mild to moderate. About Boston Pharmaceuticals Boston Pharmaceuticals, a portfolio company of B-FLEXION, is a clinical-stage biopharmaceutical company that leverages an experienced and committed drug development team to advance a portfolio of highly differentiated therapies that may address important unmet medical needs in serious liver diseases, with MASH as the focus of its lead asset. The Company has significant expansion opportunities through its portfolio of promising drug development candidates that were acquired through partnerships with proven, innovative biotechnology and pharmaceutical companies. Boston Pharmaceuticals applies rigorous decision-making to advance programs to deliver differentiated medicines to patients in need of new options while creating value for all parties involved in the journey. For more information, please visit and follow us on LinkedIn. Forward-Looking Statement This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. This communication, other than statements of historic fact, are forward-looking statements. Boston Pharmaceutical's actual results, performance or achievements could differ materially from those expressed or implied by forward-looking statements it makes as a result of a variety of risks and uncertainties. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that any product will receive or maintain regulatory approval in any territory or prove to be commercially successful. Boston Pharmaceuticals does not undertake to update or revise any such forward-looking statements to reflect actual results or changes in plans, prospects, assumptions, estimates or projections, or other circumstances occurring after the date of this presentation except as required by law.
