Liver Cirrhosis

2 May 2025. EnteroBiotix Limited (‘EnteroBiotix’), a clinical-stage biopharmaceutical company focussed on developing best-in-class drugs for gut health, today announced that results from its IMPuLCE Phase 1b trial evaluating EBX-102, the Company’s next-generation full-spectrum microbiome product, in patients with liver cirrhosis will be shared as an oral presentation at the European Association for the Study of the Liver (EASL) Congress 2025, taking place in Amsterdam, the Netherlands from 7-10 May 2025. Presentation Title: A multicentre randomised double-blind placebo-controlled phase 1b clinical trial evaluating the safety and mechanism of action of EBX-102, an oral pooled intestinal microbiota product, in liver cirrhosis: the IMPuLCE trial Presenter: Professor Ewan Forrest, Department of Gastroenterology, Glasgow Royal Infirmary, Glasgow, UK Session: Cirrhosis I: Cirrhosis & Complications Session date and Time: 09 May 2025, 08:45-09:00 CEST Presentation ID: OS-036 Location: Benhamou Room EnteroBiotix is a clinical-stage biotechnology company developing microbiome-based therapeutics for irritable bowel syndrome (IBS) and other gastrointestinal and hepatic indications. Using its proprietary platform technology, EnteroBiotix creates next-generation therapies with differentiated characteristics designed to restore and enhance gut microbiome function. The company has established independent control over the supply chain for its drug formulations, with MHRA licensed manufacturing capabilities, and a donor programme called Number2®. EBX-102 is a next-generation, full-spectrum microbiome therapeutic composed of a high-diversity consortium of gut-derived microbes. Manufactured using the Company’s proprietary AMPLA™ technology, EBX-102 has a robust stability profile and is formulated as an off-white, odourless powder encapsulated into oral capsules. It is designed to deliver rapid, well-tolerated, and effective symptom relief for diseases associated with gut microbiome dysfunction, including liver cirrhosis and complications thereof, such as hepatic encephalopathy (HE). The content above comes from the network. if any infringement, please contact us to modify.

Madrigal Pharmaceuticals’ fatty liver disease drug Rezdiffra generated $137 million in sales during the first quarter of 2025, well above analysts’ consensus expectation of $112 million. Since its historic FDA approval in March 2024 as the first medication for the treatment of the prevalent liver disease metabolic dysfunction-associated steatohepatitis (MASH), Madrigal Pharmaceuticals’ Rezdiffra has handily beat Wall Street’s sales projections for the fourth straight quarter.On a roll, Rezdiffra generated $137 million in sales during the first quarter of 2025, well above analysts’ average expectation of $112 million. The haul also marked a sequential increase from the fourth quarter’s $103 million, which also beat consensus, bringing the drug’s sales in the first 12 months on the market to $317 million.“By any measure, this is an exceptional launch,” Madrigal CEO Bill Sibold said on an investor call Thursday.“Importantly, the Rezdiffra launch continues to be driven by strong underlying patient demand,” Leerink Partners analysts wrote in a Thursday note.As of the end of March, more than 17,000 MASH patients were actively taking Rezdiffra, compared with more than 11,800 at year-end 2024, according to Madrigal. Rezdiffra’s speed of adding new patients matches that from other top-tier specialty launches, Sibold said.The launch is still at an early stage, as Madrigal is targeting 315,000 patients who fall under Rezdiffra’s FDA-approved label and are currently treated by the company’s target prescribers. Among the 6,000 top MASH prescribers targeted by Madrigal, 70% have prescribed Rezdiffra, Sibold said. Before Rezdiffra’s approval, investors were worried that the FDA would require patients to undergo a liver biopsy to determine treatment eligibility. Now that the drug’s label doesn’t require that test, a potential restriction by payers has become a new investor concern.A key opinion leader in the MASH field—who leads the fatty liver clinic at an academic center in California that takes care of about 3,000 MASH patients—recently told Leerink that he has not encountered a single payer requiring liver biopsy before granting access to Rezdiffra.The expert indicated that 90% of his patients have remained on Rezdiffra after a year of treatment, with a small percentage of discontinuations related to tolerability or lack of treatment response, according to a Leerink note on Thursday.In what Sibold described as a standard move for medicines, payers may require reauthorization of Rezdiffra after a year of treatment based on a patient’s performance. The company doesn’t see that as an issue, he said, as physicians’ feedback so far suggests the drug's efficacy has exceeded expectations.“Physicians and patients continue to highlight meaningful improvements they see on the efficacy measures that matter most to patients such as liver stiffness, liver fat, liver enzymes, LDL and triglycerides,” Sibold said on the call.Competition may be coming, though, potentially first in the form of Novo Nordisk’s formidable GLP-1 semaglutide later this year.Novo is targeting a market that’s “multiples” the size of Madrigal’s target population of 315,000 patients, Sibold noted. Given that Rezdiffra has only penetrated 5% of its own target population, Madrigal still sees “years of growth” ahead, he said.About 25% of Rezdiffra takers are already on a GLP-1 product, Sibold noted, suggesting that there’s still a need for other MASH treatments despite the GLP-1 drugs having been around for more than a decade, albeit not specifically for MASH.Semaglutide is “only going to accelerate diagnosis and add to that” target, Sibold added, suggesting Novo will expand the market to the benefit of Madrigal as well. Putting potential geographic market expansion in its own hands, Madrigal is expecting a regulatory opinion from the European Medicines Agency and subsequent EU market authorization in mid-2025. The company plans to launch first in Germany in the second half of the year.While Rezdiffra is currently approved for stage F2 and F3 non-cirrhotic MASH, also known as nonalcoholic steatohepatitis (NASH), Madrigal is also aiming to unlock the F4 cirrhotic population.The company will present detailed two-year data from the compensated MASH cirrhosis arm of the phase 3 Maestro-NAFLD-1 trial next week at the European Association for the Study of the Liver Congress. Outcomes data from the large Maestro-NASH Outcomes trial in compensated cirrhosis are expected in 2027.The expansion to F4 cirrhosis is “a key pillar of our long-term NASH leadership strategy,” Sibold said, noting that the indication could double Rezdiffra’s market opportunity.

Glasgow, Scotland – 2 May 2025. EnteroBiotix Limited (‘EnteroBiotix’), a clinical-stage biopharmaceutical company focussed on developing best-in-class drugs for gut health, today announced that results from its IMPuLCE Phase 1b trial evaluating EBX-102, the Company’s next-generation full-spectrum microbiome product, in patients with liver cirrhosis will be shared as an oral presentation at the European Association for the Study of the Liver (EASL) Congress 2025, taking place in Amsterdam, the Netherlands from 7-10 May 2025. Oral Presentation DetailsPresentation Title: A multicentre randomised double-blind placebo-controlled phase 1b clinical trial evaluating the safety and mechanism of action of EBX-102, an oral pooled intestinal microbiota product, in liver cirrhosis: the IMPuLCE trialPresenter: Professor Ewan Forrest, Department of Gastroenterology, Glasgow Royal Infirmary, Glasgow, UKSession: Cirrhosis I: Cirrhosis & ComplicationsSession date and Time: 09 May 2025, 08:45-09:00 CESTPresentation ID: OS-036Location: Benhamou Room About EnteroBiotixEnteroBiotix is a clinical-stage biotechnology company developing microbiome-based therapeutics for irritable bowel syndrome (IBS) and other gastrointestinal and hepatic indications. Using its proprietary platform technology, EnteroBiotix creates next-generation therapies with differentiated characteristics designed to restore and enhance gut microbiome function. The company has established independent control over the supply chain for its drug formulations, with MHRA licensed manufacturing capabilities, and a donor programme called Number2®. About EBX-102EBX-102 is a next-generation, full-spectrum microbiome therapeutic composed of a high-diversity consortium of gut-derived microbes. Manufactured using the Company’s proprietary AMPLA™ technology, EBX-102 has a robust stability profile and is formulated as an off-white, odourless powder encapsulated into oral capsules. It is designed to deliver rapid, well-tolerated, and effective symptom relief for diseases associated with gut microbiome dysfunction, including liver cirrhosis and complications thereof, such as hepatic encephalopathy (HE). Media contacts EnteroBiotixDr James McIlroy, CEOinfo@enterobiotix.com ICR HealthcareNamrata Taak, Kris Lamenterobiotix@ICRHealthcare.com