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Cushing Syndrome Leaves Lasting Health Effects
Cushing Syndrome Leaves Lasting Health Effects

Medscape

time4 days ago

  • Health
  • Medscape

Cushing Syndrome Leaves Lasting Health Effects

TOPLINE: Compared with a matched population-based control group, patients with Cushing syndrome continued to exhibit elevated systolic and diastolic blood pressures along with reduced kidney function at least 14 years after biochemical remission. METHODOLOGY: Researchers in Germany conducted a retrospective cohort study to assess the long-term trajectory of blood pressure and kidney function in patients who achieved remission of Cushing syndrome. They included 81 patients with Cushing syndrome (median age at baseline, 44 years; 75.3% women) and compared them with 243 matched control individuals from a population-based cohort. Data were collected before treatment at baseline and at median follow-up intervals of 7.1 and 14 years after biochemical remission, with assessments of blood pressure, glomerular filtration rate, the prevalence of chronic kidney disease, and the use of antihypertensives. TAKEAWAY: Patients with Cushing syndrome had a significant reduction in blood pressure and required fewer antihypertensives at both 7 and 14 years vs baseline. However, when compared with the control group, patients with Cushing syndrome had significantly elevated systolic and diastolic pressures at baseline and 7 and 14 years post-remission (P ≤ .0002 for all). Although the proportion of patients on antihypertensive medications decreased in the Cushing syndrome group after remission was achieved, the prevalence of uncontrolled hypertension remained higher than in the control group at all follow-up points. In fact, reducing the use of these medications was associated with an increased risk for uncontrolled hypertension. Kidney function assessed via glomerular filtration rate remained consistently lower among patients with Cushing syndrome than among control individuals at baseline and 7 and 14 years post-remission (P = .005, P < .0001, and P = .0359, respectively). IN PRACTICE: "Our findings provide further evidence that cardiovascular effects of hypercortisolism are not entirely reversible with the normalization of cortisol levels and enhance our understanding of the deteriorative long-term cardiovascular consequences of chronic hypercortisolism," the authors wrote. SOURCE: This study was led by Katrin Ritzel, Ludwig-Maximilians-Universität München (LMU Munich), LMU University Hospital in Munich, Germany. It was published online on July 29, 2025, in Journal of Endocrinological Investigation. LIMITATIONS: The retrospective design and single-centre nature of this study could have been considered limitations. DISCLOSURES: This study was supported by Else Kröner-Fresenius Stiftung. Some authors reported being supported by Deutsche Forschungsgemeinschaft, the Munich Clinician Scientist Program, the Clinician Scientist Pro­gramme on Rare Important Syndromes in Endocrinology, and other sources. All authors reported having no conflicts of interest. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

Kidney Function Tests
Kidney Function Tests

Health Line

time15-07-2025

  • Health
  • Health Line

Kidney Function Tests

Key takeaways Kidney function tests are simple blood and urine tests that can identify problems with your kidneys. These tests can estimate your glomerular filtration rate (GFR), which indicates how quickly your kidneys are clearing waste from your body. Your doctor will focus on treating the underlying condition if your tests show early kidney disease. This may include medications, lifestyle changes, or seeing a specialist. Overview of kidney function tests You have two kidneys on either side of your spine that are each approximately the size of a human fist. They're located posterior to your abdomen and below your rib cage. Your kidneys play several vital roles in maintaining your health. One of their most important jobs is to filter waste materials from the blood and expel them from the body as urine. The kidneys also help control the levels of water and various essential minerals in the body. In addition, they're critical to the production of: vitamin D red blood cells hormones that regulate blood pressure If your doctor thinks your kidneys may not be working properly, you may need kidney function tests. These are simple blood and urine tests that can identify problems with your kidneys. You may also need kidney function testing done if you have other conditions that can harm the kidneys, such as diabetes or high blood pressure. They can help doctors monitor these conditions. Symptoms of kidney problems Symptoms that may indicate a problem with your kidneys include: high blood pressure blood in the urine frequent urges to urinate difficulty beginning urination painful urination swelling of the hands and feet due to a buildup of fluids in the body A single symptom may not mean something serious. However, when occurring simultaneously, these symptoms suggest that your kidneys aren't working properly. Kidney function tests can help determine the reason. Types of kidney function tests To test your kidney function, your doctor will order a set of tests that can estimate your glomerular filtration rate (GFR). Your GFR tells your doctor how quickly your kidneys are clearing waste from your body. Urinalysis A urinalysis screens for the presence of protein and blood in the urine. There are many possible reasons for protein in your urine, not all of which are related to disease. Infection increases urine protein, but so does a heavy physical workout. Your doctor may want to repeat this test after a few weeks to see if the results are similar. Your doctor may also ask you to provide a 24-hour urine collection sample. This can help doctors see how fast a waste product called creatinine is clearing from your body. Creatinine is a breakdown product of muscle tissue. Serum creatinine test This blood test examines whether creatinine is building up in your blood. The kidneys usually completely filter creatinine from the blood. A high level of creatinine suggests a kidney problem. According to the National Kidney Foundation (NKF), a creatinine level higher than 1.2 milligrams/deciliter (mg/dL) for women and 1.4 mg/dL for men is a sign of a kidney problem. Blood urea nitrogen (BUN) The blood urea nitrogen (BUN) test also checks for waste products in your blood. BUN tests measure the amount of nitrogen in the blood. Urea nitrogen is a breakdown product of protein. However, not all elevated BUN tests are due to kidney damage. Common medications, including large doses of aspirin and some types of antibiotics, can also increase your BUN. It's important to tell your doctor about any medications or supplements that you take regularly. You may need to stop certain drugs for a few days before the test. A normal BUN level is between 7 and 20 mg/dL. A higher value could suggest several different health problems. Estimated GFR This test estimates how well your kidneys are filtering waste. The test determines the rate by looking at factors, such as: test results, specifically creatinine levels age gender race height weight Any result lower than 60 milliliters/minute/1.73m 2 may be a warning sign of kidney disease. How the tests are performed Kidney function tests usually require a 24-hour urine sample and a blood test. 24-hour urine sample A 24-hour urine sample is a creatinine clearance test. It gives your doctor an idea of how much creatinine your body expels over a single day. On the day that you start the test, urinate into the toilet as you normally would when you wake up. For the rest of the day and night, urinate into a special container provided by your doctor. Keep the container capped and refrigerated during the collection process. Make sure to label the container clearly and to tell other family members why it's in the refrigerator. On the morning of the second day, urinate into the container when you get up. This completes the 24-hour collection process. Follow your doctor's instructions about where to drop the sample off. You may need to return it either to your doctor's office or a laboratory. Blood samples BUN and serum creatinine tests require blood samples taken in a lab or doctor's office. The technician drawing the blood first ties an elastic band around your upper arm. This makes the veins stand out. The technician then cleans the area over the vein. They slip a hollow needle through your skin and into the vein. The blood will flow back into a test tube that will be sent for analysis. You may feel a sharp pinch or prick when the needle enters your arm. The technician will place gauze and a bandage over the puncture site after the test. The area around the puncture may develop a bruise over the next few days. However, you shouldn't feel severe or long-term pain. Treatment of early kidney disease Your doctor will focus on treating the underlying condition if the tests show early kidney disease. Your doctor will prescribe medications to control blood pressure if the tests indicate hypertension. They'll also suggest lifestyle and dietary modifications. If you have diabetes, your doctor may want you to see an endocrinologist. This type of doctor specializes in metabolic diseases and can help ensure that you have the best blood glucose control possible. If there are other causes of your abnormal kidney function tests, such as kidney stones and excessive use of painkillers, your doctor will take appropriate measures to manage those disorders.

ProKidney Reports Statistically and Clinically Significant Topline Results for the Phase 2 REGEN-007 Trial Evaluating Rilparencel in Patients with Chronic Kidney Disease and Diabetes
ProKidney Reports Statistically and Clinically Significant Topline Results for the Phase 2 REGEN-007 Trial Evaluating Rilparencel in Patients with Chronic Kidney Disease and Diabetes

Yahoo

time08-07-2025

  • Business
  • Yahoo

ProKidney Reports Statistically and Clinically Significant Topline Results for the Phase 2 REGEN-007 Trial Evaluating Rilparencel in Patients with Chronic Kidney Disease and Diabetes

Full results from REGEN-007 are being held and will be submitted to the American Society of Nephrology 2025 Kidney Week as a late-breaking clinical trial In Group 1 (n=24), kidney function stabilized in patients randomized to receive two rilparencel injections (one in each kidney). The annual decline in eGFR slope improved by 78% from -5.8 mL/min/1.73m2 in the pre-injection period to -1.3 mL/min/1.73m2 in the period following the last rilparencel injection. This 4.6 mL/min/1.73m2 per year difference was statistically significant (p<0.001) and clinically meaningful In Group 2 (n=25), patients were randomized to receive a single rilparencel injection followed by a second injection only if kidney function worsened and a re-dosing trigger was met. The annual decline in eGFR slope improved by 50% from -3.4 mL/min/1.73m2 in the pre-injection period to -1.7 mL/min/1.73m2 in the period following the last rilparencel injection. This 1.7 mL/min/1.73m2 per year difference was not statistically significant (p=0.085) but suggests evidence of a dose response No rilparencel-related serious adverse events were observed; the safety profile was consistent with previously reported study results and comparable to a kidney biopsy FDA Type B meeting set for this summer to confirm ProKidney's approach to using eGFR slope as the surrogate endpoint in the ongoing Phase 3 PROACT 1 study for accelerated approval WINSTON-SALEM, N.C., July 08, 2025 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) ('ProKidney' or the 'Company"), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today reported statistically significant and clinically meaningful positive topline results from the full Group 1 modified intent-to-treat (mITT) population of the Phase 2 REGEN-007 trial evaluating rilparencel in patients with CKD and diabetes. Rilparencel is an autologous cellular therapy that has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food & Drug Administration (FDA) and is currently being evaluated in the ongoing Phase 3 REGEN-006 (PROACT 1) trial to demonstrate the therapy's potential to preserve kidney function in patients with advanced CKD and type 2 diabetes. 'We are very encouraged by the REGEN-007 topline results that demonstrated a robust improvement in eGFR slope following treatment with rilparencel in Group 1 as well as evidence of a dose response in Group 2. These data bolster our confidence in the design of our ongoing Phase 3 PROACT 1 study given the similarity between the dosing regimen in REGEN-007 Group 1 and PROACT 1. It is also worth noting that 15 of the 24 patients in Group 1 (63%) met key Phase 3 PROACT 1 inclusion criteria, and similar efficacy results were observed in this subgroup compared to the full Group 1 results. We plan to submit the full results from REGEN-007 to ASN's 2025 Kidney Week as a late-breaking clinical trial and are excited to share more details at that time with investors and the medical community,' said Bruce Culleton, M.D., CEO of ProKidney. 'We also look forward to our upcoming FDA Type B meeting in the coming weeks to confirm our approach to eGFR slope as a surrogate endpoint for accelerated approval. This meeting represents an important step toward our goal of expediting rilparencel's potential path to market in the U.S. where there remains a significant unmet clinical need in patients with advanced CKD and diabetes.' Phase 2 REGEN-007 Overview and Topline ResultsREGEN-007 is a multi-center Phase 2 open-label 1:1 randomized two-arm trial in patients with diabetes, CKD, and an estimated glomerular filtration rate (eGFR) of 20-50 mL/min/1.73m². At randomization, patients were assigned to one of two treatment groups using different dosing regimens. Group 1 replicated the dosing schedule of the ongoing Phase 3 PROACT 1 study in which patients received two scheduled rilparencel injections (one in each kidney), approximately three months apart. Group 2 tested an exploratory dosing regimen to investigate whether disease progression triggers, rather than a time-based trigger, could optimize multiple administrations of rilparencel. In Group 2, patients received a single rilparencel injection in one kidney and a second injection in the contralateral kidney only if triggered by a sustained eGFR decline from baseline of ≥ 20%, and/or an increase in the urine albumin to creatinine ratio (UACR) from baseline of ≥ 30% and ≥ 30 mg/g. The prespecified primary endpoint for REGEN-007 is the difference in annual eGFR slope (calculated using a linear mixed effects model) in the pre-injection period versus the period following the last rilparencel injection. The pre-injection period included all historical eGFR values collected up to 24 months before the screening visit as well as the on-study central laboratory eGFR results prior to first rilparencel injection. The period following the last injection included eGFR values from the last rilparencel injection to the end of study (EOS) visit. Median follow-up after the last injection was approximately 18 months in both Group 1 and Group 2. Fifty-three patients were randomized in the study, of whom 49 patients (mITT population) received at least one rilparencel injection. Four patients did not receive any rilparencel injections. The majority of patients were male (69%), and the mean age was 60 years. At baseline, 38 of 49 patients (78%) had type 2 diabetes mellitus and 11 (22%) had type 1 diabetes. Thirty-nine (80%) patients were receiving an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB), and 18 (37%) were receiving a sodium-glucose cotransporter-2 inhibitor (SGLT2i). At baseline, the mean (SD) eGFR was 33±10 mL/min/1.73m2. Notably, the median UACR was higher in Group 1 (792 mg/g) compared to Group 2 (229 mg/g). Annual eGFR Slope (mL/min/1.73m2) Group N (mITT) Pre inj Post last inj Absolute benefit Relative benefit 1 24 -5.8 -1.3 4.6 78% 2 25 -3.4 -1.7 1.7 50% In Group 1 (n=24), kidney function stabilized after receiving rilparencel. The annual decline in eGFR slope improved by 78% from -5.8 mL/min/1.73m2 in the pre-injection period to -1.3 mL/min/1.73m2 in the period following the last rilparencel injection. This 4.6 mL/min/1.73m2 per year difference1 was statistically significant (p<0.001) and clinically meaningful. Of the 24 patients in Group 1, 15 (63%) met key Phase 3 PROACT 1 inclusion criteria, and similar efficacy results were observed in this subgroup compared to the full Group 1 results. As a reminder, the Phase 3 PROACT 1 protocol was amended in 1H 2024 after a similar eGFR efficacy signal was observed in the Phase 2 RMCL-002 study subgroup analysis (n=23) of high-UACR, Stage 4 CKD patients with type 2 diabetes. In Group 2 (n=25), the annual change in kidney function as measured by eGFR slope was -3.4 mL/min/1.73m2 in the pre-injection period versus -1.7 mL/min/1.73m2 in the period following the last rilparencel injection, resulting in an improvement of 50%, or 1.7 mL/min/1.73m2 per year. This difference was not statistically significant (p=0.085) but suggests evidence of a dose response. Out of the 25 patients in Group 2, 15 (60%) met the re-dosing trigger and received a second rilparencel injection. The median time between the first and second injections in these 15 patients was approximately 11 months. No rilparencel-related serious adverse events were observed across all patients in the study who received at least one rilparencel injection (n=49). The safety profile was consistent with previously reported study results and comparable to a kidney biopsy. Full results from REGEN-007 are being held and will be submitted to the American Society of Nephrology (ASN) 2025 Kidney Week as a late-breaking clinical trial. Phase 3 PROACT 1 Regulatory ProgressAs previously communicated, the FDA confirmed during a Type B meeting in Q4 2024 that the accelerated approval pathway is available for rilparencel if an acceptable surrogate endpoint, such as eGFR slope, is used. ProKidney has an upcoming FDA Type B meeting this summer to confirm the approach to using eGFR slope as the surrogate endpoint for accelerated approval. Additional details are expected in mid-2025. About Chronic Kidney DiseaseCKD is a progressive condition characterized by the gradual decline of kidney function, which can ultimately lead to end-stage kidney disease (ESKD) requiring dialysis or transplantation. An estimated 37 million adults in the U.S. have CKD, though many remain undiagnosed in the early stages. Diabetes is the leading cause of CKD, and individuals with both conditions face significantly elevated risks of cardiovascular events, hospitalization, and mortality. ProKidney is developing rilparencel for patients with Stage 3b/4 CKD and diabetes, a population that includes 1 to 2 million people in the U.S. While current treatment options aim to slow disease progression, there remains a substantial unmet need for therapies that can stabilize kidney function and delay or prevent the need for dialysis in patients with advanced CKD. About the Phase 3 REGEN-006 (PROACT 1) Clinical TrialREGEN-006 is an ongoing Phase 3, randomized, blinded, sham controlled safety and efficacy study of rilparencel in subjects with advanced CKD and type 2 diabetes. The study protocol was amended in 1H 2024 to focus on a subset of patients with Stage 4 CKD (eGFR 20-30 mL/min/1.73m²) and late Stage 3b CKD (eGFR 30-35 mL/min/1.73m²) with accompanying albuminuria (UACR less than 5,000 mg/g for patients with eGFR 20-30 mL/min/1.73m² and 300-5,000 mg/g for patients with eGFR 30-35 mL/min/1.73m²). The total planned enrollment is approximately 685 subjects. Subjects are randomized (1:1) to the treatment group and the sham control group prior to kidney biopsy or a sham biopsy procedure, respectively. The primary objective is to assess the efficacy of up to two rilparencel injections (one in each kidney) using a minimally invasive percutaneous approach. The primary composite endpoint is the time from first injection to the earliest of: at least 40% reduction in eGFR; eGFR <15 mL/min/1.73m², and/or chronic dialysis, and/or renal transplant; or renal or cardiovascular death. About ProKidney a pioneer in the treatment of chronic kidney disease through innovations in cellular therapy, was founded in 2015 after a decade of research. ProKidney's lead product candidate, rilparencel (also known as REACT®), is a first-in-class, patented, proprietary autologous cellular therapy being evaluated for its potential to preserve kidney function in diabetic patients at high risk of kidney failure. Rilparencel has received RMAT designation from the FDA. For more information, please visit Forward-Looking StatementsThis press release includes 'forward-looking statements' within the meaning of the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. ProKidney's actual results may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as 'expect,' 'estimate,' 'project,' 'budget,' 'forecast,' 'anticipate,' 'intend,' 'plan,' 'may,' 'will,' 'could,' 'should,' 'believes,' 'predicts,' 'potential,' 'continue,' and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, the Company's beliefs that the FDA agrees that the Company's Phase 3 REGEN-006 (PROACT 1) trial could be sufficient to support a potential BLA submission and full regulatory approval and that the Company could consider using eGFR slope as a surrogate endpoint on an accelerated approval pathway for rilparencel, expectations with respect to financial results and expected cash runway, including the Company's expectation that current cash will support operating plans into 2027, future performance, development and commercialization of products, if approved, the potential benefits and impact of the Company's products, if approved, potential regulatory approvals, the size and potential growth of current or future markets for the Company's products, if approved, the advancement of the Company's development programs into and through the clinic and the expected timing for reporting data, the making of regulatory filings or achieving other milestones related to the Company's product candidates, and the advancement and funding of the Company's developmental programs, generally. Most of these factors are outside of the Company's control and are difficult to predict. Factors that may cause such differences include, but are not limited to: disruptions to our business or that may otherwise materially harm our results of operations or financial condition as a result of our recent domestication to the United States; the inability to maintain the listing of the Company's Class A common stock on Nasdaq; the inability of the Company's Class A common stock to remain included in various indices and the potential negative impact on the trading price of the Class A common stock if excluded from such indices; the inability to implement business plans, forecasts, and other expectations or identify and realize additional opportunities, which may be affected by, among other things, competition and the ability of the Company to grow and manage growth profitably and retain its key employees; the risk of downturns and a changing regulatory landscape in the highly competitive biotechnology industry; the risk that results of the Company's clinical trials may not support approval; the risk that the FDA could require additional studies before approving the Company's drug candidates; the inability of the Company to raise financing in the future; the inability of the Company to obtain and maintain regulatory clearance or approval for its products, and any related restrictions and limitations of any cleared or approved product; the inability of the Company to identify, in-license or acquire additional technology; the inability of Company to compete with other companies currently marketing or engaged in the biologics market and in the area of treatment of kidney diseases; the size and growth potential of the markets for the Company's products, if approved, and its ability to serve those markets, either alone or in partnership with others; the Company's estimates regarding expenses, future revenue, capital requirements and needs for additional financing; the Company's financial performance; the Company's intellectual property rights; uncertainties inherent in cell therapy research and development, including the actual time it takes to initiate and complete clinical studies and the timing and content of decisions made by regulatory authorities; the fact that interim results from our clinical programs may not be indicative of future results; the impact of geo-political conflict on the Company's business; and other risks and uncertainties included under the heading 'Risk Factors' in the Company's most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. The Company cautions readers that the foregoing list of factors is not exclusive and cautions readers not to place undue reliance upon any forward-looking statements, which speak only as of the date made. The Company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based. Investor Contacts: ProKidneyEthan Advisors, LLCDaniel Ferry Daniel@ 1 Difference in values is due to in to access your portfolio

Vivoryon Therapeutics NV (FRA:05Y) Q1 2025 Earnings Call Highlights: Significant Reduction in ...
Vivoryon Therapeutics NV (FRA:05Y) Q1 2025 Earnings Call Highlights: Significant Reduction in ...

Yahoo

time18-06-2025

  • Business
  • Yahoo

Vivoryon Therapeutics NV (FRA:05Y) Q1 2025 Earnings Call Highlights: Significant Reduction in ...

Research and Development Expenses: EUR1.2 million in Q1 2025, down from EUR7.4 million in Q1 2024. General and Administrative Expenses: EUR1.3 million in Q1 2025, compared to EUR2.1 million in Q1 2024. Net Loss: EUR2.4 million in Q1 2025, compared to EUR9.1 million in Q1 2024. Cash and Cash Equivalents: EUR7 million as of March 31, 2025, down from EUR9.4 million as of December 31, 2024. Warning! GuruFocus has detected 3 Warning Signs with FRA:05Y. Release Date: June 17, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Vivoryon Therapeutics NV (FRA:05Y) reported statistically significant and clinically meaningful improvements in kidney function with varoglutamstat in Phase 2 studies. The company has strengthened its intellectual property position with recent patent filings, including a new US composition of matter patent for varoglutamstat, supporting market exclusivity through 2044. Varoglutamstat has shown synergistic effects when combined with standard of care therapies in preclinical studies, enhancing its potential positioning in the market. The company has a clear development pathway for varoglutamstat, with plans to initiate a Phase 2b study in diabetic kidney disease. Vivoryon Therapeutics NV (FRA:05Y) has reduced its net loss significantly from EUR9.1 million in Q1 2024 to EUR2.4 million in Q1 2025, indicating improved financial management. The primary endpoint of cognition in the Phase 2 studies failed, which could impact the perception of varoglutamstat's overall efficacy. Vivoryon Therapeutics NV (FRA:05Y) reported a decrease in cash and cash equivalents from EUR9.4 million at the end of 2024 to EUR7 million as of March 31, 2025, which may affect future operations. The company is actively pursuing additional financing and partnership opportunities, indicating potential financial constraints. There is a significant unmet need for effective treatments for kidney diseases, and current therapies can only slow disease progression, highlighting the competitive and challenging market landscape. The company needs to ensure successful execution of its development plan, including the Phase 2b study, to maintain momentum and investor confidence. Q: What steps can Vivoryon Therapeutics take with its current cash position to prepare for the planned Phase 2b trial in diabetic kidney disease (DKD), and what are the optimal funding solutions for this trial? A: Frank Weber, CEO, explained that the company is in advanced protocol design discussions with CROs and experts, focusing on understanding the full development path through Phase 3. They are also considering study medication and financial aspects to prepare for the trial. Regarding funding, they are exploring partnership opportunities and other financing options to support the trial. Q: How are partnership discussions progressing, and are they reaching a more advanced state? A: Frank Weber, CEO, stated that Vivoryon is in ongoing conversations with interested pharma companies. They are assessing whether a partnership would be in the best interest of the company and its shareholders, given the unique data they have. Q: What proportion of patients in the US and Europe are currently receiving SGLT-2 inhibitors for DKD? A: Frank Weber, CEO, noted that SGLT-2 inhibitors are recommended in guidelines and are gaining traction, with approximately 30% to 35% of the potential population currently receiving them. The market penetration is increasing, although diagnosing patients in early stages remains a challenge. Q: Were there any key takeaways from the recent ERA Congress that could be incorporated into the Phase 2b trial design? A: Frank Weber, CEO, mentioned that the ERA Congress provided supportive feedback and insights into trial design. They are considering including patients with high proteinuria in Stage 3a, as these patients have a high risk of progression. Overall, the trial design is largely confirmed, with some adjustments to exclusion criteria. Q: What are the financial highlights for Vivoryon Therapeutics in the first quarter of 2025? A: Anne Doering, CFO, reported a net loss of EUR 2.4 million for Q1 2025, compared to EUR 9.1 million in Q1 2024. The company held EUR 7 million in cash as of March 31, 2025. The decrease in expenses was due to lower clinical and manufacturing costs following the ramp-down of previous studies. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Error 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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