Latest news with #Alport


Business Wire
3 days ago
- Business
- Business Wire
ENYO Pharma Announces Completion of Series C Financing With Vesalius Biocapital and Continued Progress of Its ALPESTRIA-1 Clinical Phase 2 Study in Alport Syndrome Patients
LYON, France--(BUSINESS WIRE)--ENYO Pharma ('ENYO'), a clinical-stage biotechnology company focused on developing FXR agonists for the treatment of severe kidney diseases, today announced the smooth continuation of its Phase 2 ALPESTRIA-1 trial in 26 Alport syndrome patients. The topline results from the trial are on track for the fourth quarter of 2025. In parallel, ENYO has finalized its Series C financing round with a €6 million investment from Vesalius Biocapital IV, bringing the total Series C raise to €32 million. The ongoing ALPESTRIA-1 study evaluates Vonafexor, a highly selective and oral FXR agonist, in patients with Alport syndrome, a rare genetic kidney disease with no approved therapy. The trial involves a 24-week ascending doses regimen followed by a 12-week off-treatment observation period. ALPESTRIA-1 was launched mid 2024 in 4 countries (US, F, SP and D) following Orphan Drug Designation from both the FDA and EMA. The new funding from Vesalius Biocapital IV extends ENYO's cash runway through the second half of 2026 and enables the initiation of two new clinical programs: A proof-of-concept trial in patients with Chronic Kidney Disease (CKD) grade 3 and concurrent F2/F3 MASH, building on the promising renal results from the previous Phase 2 LIVIFY clinical study; A PK/PD head-to-head comparison of Vonafexor and its analog EYP651 in healthy subjects. In addition, ENYO will continue to expand its preclinical portfolio, notably in Autosomal Dominant Polycystic Kidney Disease (ADPKD), where the Vonafexor franchise could offer a novel and disease-modifying approach. ' We are pleased with the continued progress of ALPESTRIA-1 and honored to welcome Vesalius Biocapital to our investor syndicate and Dr. Jean-Christophe Renondin as new Board member,' said Dr. Jacky Vonderscher, CEO of ENYO. ' This additional investment will allow us to accelerate the development of our FXR agonist pipeline in both rare and more prevalent kidney diseases. We share a common belief with Vesalius in the transformative potential of Vonafexor and EYP651 for patients suffering from inflammation- and fibrosis-driven renal conditions.' ' Vesalius Biocapital is excited to support ENYO as it progresses into the next phase of clinical development for Vonafexor and its analog EYP651, ' commented Dr. Jean-Christophe Renondin, Managing Partner at Vesalius Biocapital IV. ' There is an immense need for new treatments in kidney conditions such as Alport Syndrome and CKD. We believe Vonafexor has the potential to help these patients and make a meaningful impact on their lives. I look forward to working with ENYO's excellent leadership team to advance this promising therapeutic candidate.' About ENYO Pharma: ENYO is a clinical-stage biopharmaceutical company headquartered in Lyon (France) and developing proprietary drug candidates to improve quality of life and avoid end stage renal disease and dialysis/transplantation for patients with rare and common kidney diseases. Since its inception ENYO collected extensive phase I/II clinical data through nine completed clinical studies with ca. 400 subjects. ENYO is supported by a strong syndicate of global investors: OrbiMed, Morningside, AndEra, BPIFrance (InnoBio and Large Venture), Sofinnova Partners and Vesalius). For more information: ENYO Pharma About Vesalius Biocapital: Vesalius is a specialist life sciences venture capital investor, investing in companies in later stage companies in drug development, medical device diagnostic and e-health since 2007. Vesalius Biocapital IV, launched in June 2023, targets first and best-in-class European life science companies in drug development and digital health. Its investment portfolio is well balanced between drug development and non-drug development investments and committed to providing capital to science-backed innovation and ambitious entrepreneurs. The team is based in Europe to explore investment opportunities and valuation potential for the portfolio. Managing Partners include Guy Geldhof, Dr Jean-Christophe Renondin and Stéphane Verdood.


Business Insider
08-05-2025
- Business
- Business Insider
Bayer's treatment of Alport syndrome granted FDA orphan designation
Bayer's (BAYRY) treatment of Alport syndrome was granted FDA orphan designation, according to a post to the agency's site. Protect Your Portfolio Against Market Uncertainty Discover companies with rock-solid fundamentals in TipRanks' Smart Value Newsletter. Receive undervalued stocks, resilient to market uncertainty, delivered straight to your inbox. Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Yahoo
18-04-2025
- Health
- Yahoo
Local 28-year-old man needs second kidney transplant
BOARDMAN, Ohio (WKBN) – Mike Rogers, Jr. is in need of a new kidney for the second time, and he is only 28 years old. 'Once I get that transplant, I want to be physically fit. I want to be mentally ready so that I can go back to living a normal life,' Rogers said. Rogers has Alport syndrome, a genetic condition that impacts his kidneys, which was passed down to him from his mother. According to the Cleveland Clinic, those with Alport syndrome may experience kidney failure as well as hearing and vision loss. The Cleveland Clinic reports that it is a rare disease that affects fewer than 200,000 people in the United States. Rogers first noticed symptoms of the condition when he was young. The condition began to take control and shut down his kidneys in September 2017. After a year of waiting for a kidney transplant, he matched with a family friend who had passed away. He got his first transplant on December 7, 2018. 'It saved my life. I was healthy. For a while, I was able to do things, had lived a normal life again, and medications and stuff like that helped me,' Rogers said. After the transplant, his life flourished for years. He was able to land a good job, and he befriended the staff of Renegade Toys in Boardman. He has worked there part-time over the past six years. Renegade Toys co-owner Walter Raniolo first met Rogers when he was trying to get his first kidney transplant. 'He had missed years of where he could have been in college, or could have been educated, and we brought him here and trained him pretty much. He was very knowledgeable in the topics and subjects we have here,' Raniolo said. This January, Rogers became sick. He contracted double pneumonia, which took a toll on his transplant. He had to be quickly put back on dialysis. Rogers now has to do treatments three days a week. 'Since I'm older, it's beaten me up a lot more than it did before. I'm a lot more tired and I don't have a lot of energy,' Rogers said. Rogers admitted that he is going through an immense struggle. He said that he struggles to use the restroom and that he is limited to drinking only 32 ounces of fluid per day. Rogers goes through pain almost daily. He finds peace when he is in the company of his family and friends. 'I try to fight, you know, not to just go home and just sit by myself. You know I want to go out, talk to people instead of just sitting at home and feeling bad,' he said. Rogers said that he has a mindset of hoping for the best while preparing for the worst so that he is ready for whatever happens next. 'Something good is going to come. Something good is going to happen. But preparing for the worst is also preparing for the likelihood that something bad could happen, or something might not go the way that you want it. And that's OK, because that's that's life,' he said. Raniolo was there for Rogers in the hospital when he first found out about his kidney transplant going bad. Raniolo and the team have started raising money for Rogers through a ticket raffle. Raniolo explained that he wanted to help try to take the pressure off Rogers' everyday life. 'I don't know where I would be in his situation. I don't know what I would do. He's keeping a very positive approach to this. So it is awe-inspiring,' Raniolo said. Rogers still awaits a new kidney so that he can be given a new life again. He explained why it's important for everyone to be an organ donor. 'Those organs, the tissues, and anything can go and save and prolong somebody else's life, and give them a better chance at living a fulfilling life,' Rogers said. Rogers jokingly calls himself the mascot of Renegade Toys. He performs comedy skits in a gorilla mask with his coworkers in the store. The Flying Jalopy and the Grizzly Viking Gorilla perform at local toy expos in the area as well. Rogers looks at the gorilla as a symbol of strength, and he loves getting to entertain his fans. Rogers and his friends raised $100 for Angels For Animals as well. 'A lot of kids and people in the area love it. We have a little fan base,' Rogers said. Rogers and Renegade Toys will be at the Super Toy Events expo at the Canfield Fairgrounds on Saturday, April 19, collecting donations for the raffle from 10 a.m. – 3 p.m. Tickets are $5 a piece and they can be purchased at the event or at Renegade Toys on Market Street in Boardman during store hours. The winner of the raffle drawing will receive a number of quality, rare items ranging from action figures to Air Jordan tennis shoes. The winning ticket will be drawn on Saturday, April 26, at the store. You can watch the drawing of the winning ticket on their Facebook page. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.