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Mark Pruzanski has found another fibrosis drug developer to lead, and this time he’s also venturing into oncology. The biotech industry veteran has joined Swiss startup Alentis Therapeutics as its new CEO, the company exclusively told Endpoints News . Pruzanski is known for helping make the fatty liver disease NASH (now MASH) a hotspot as the longtime leader of Intercept Pharmaceuticals. Alentis has multiple antibodies and antibody-drug conjugates already in clinical trials, thanks to a $181.4 million Series D last November. It’s testing the ADC candidates ALE.P02 and ALE.P03 in patients with certain CLDN1+ tumors. It’s also investigating the monoclonal antibody lixudebart in patients with varying forms of fibrosis, which includes scarring of certain organs. Pruzanski succeeds Roberto Iacone, who has served as CEO since 2020. In an emailed statement, Iacone said he’s “confident Alentis will continue to thrive and reach new heights” under Pruzanski’s leadership. Pruzanski’s decision-making has been instrumental elsewhere in the industry. After Intercept, he went on to lead Versanis Bio, which took a former Novartis muscle disorder drug and repositioned it as a muscle mass-sparing obesity medicine — then sold the biotech to Eli Lilly in a deal that could be worth as much as $1.9 billion. He’s also the chairman of obesity biotech Verdiva Bio , as well as the autoimmune startup Abcuro . Hello, Christian Fernandez! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Christian Fernandez! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Christian Fernandez! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Christian Fernandez! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Christian Fernandez! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Christian Fernandez! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Christian Fernandez! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Christian Fernandez. You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. All three of Alentis’ clinical-stage assets will have clinical data within the next year, Pruzanski said in an interview with Endpoints on Tuesday. “We should have sufficient data to catalyze the next step in the company’s evolution from a financing, potential strategic standpoint,” Pruzanski said. That could include moving toward a possible IPO, he said. A majority of the six-year-old biotech’s 40 employees are based in Basel. Pruzanski said he plans to remain in the New York area to help continue building a “transatlantic footprint.” “As we continue to advance the current crop of clinical-stage assets and build out our pipeline, we’ve got a terrific internal discovery effort that’s ongoing focused on next-generation molecules. We’ll have to expand the company to build the pipeline as well,” Pruzanski said. The role is Pruzanski’s first time as a cancer CEO. “For the last number of years, after transitioning out of Intercept, I was flirting with the idea of getting into oncology,” Pruzanski said. “I looked at a lot of different companies and modalities, and Alentis is the first where I thought that this is truly exciting. ADCs, of course, are a modality that is proven but with a lot more room for innovation.”

Bengaluru: Intercept Pharmaceuticals said on Thursday it is withdrawing its liver disease drug from the U.S. market following a request from the Food and Drug Administration. This comes as another setback for the company after the U.S. FDA last year declined full approval for the drug, Ocaliva , and said it had identified cases of liver injury in patients who were on it. Ocaliva, chemically known as obeticholic acid , got the FDA's accelerated approval in 2016 to treat patients with primary biliary cholangitis, a rare disease that causes inflammation of small bile ducts in the liver and can eventually destroy them. Under the accelerated pathway, the FDA mandates additional post-market trials that verify the drug's benefits. If data from the trials do not show the drug's effectiveness, the regulator can ask the company to withdraw it from the market. The FDA had said in December the drug was being studied for any injury to the organ in patients without severe scarring, based on its review of post-market clinical trial data. In 2021, the regulator had restricted the use of Ocaliva in patients with advanced cirrhosis or scarring of the liver. The FDA has also placed a clinical hold on all Intercept clinical trials conducted in the U.S. involving obeticholic acid, the company said on Thursday. Intercept added that it will provide additional information to healthcare professionals and patients as it works with the FDA on the transition process. (Reporting by Sneha S K in Bengaluru; Editing by Shreya Biswas)

After attempts to earn a full approval for Ocaliva in primary biliary cholangitis, Intercept Pharmaceuticals is pulling the plug on the drug in the U.S. based on the request of the FDA. After years of regulatory struggles for Intercept Pharmaceuticals and its liver disease drug Ocaliva (obeticholic acid), the FDA has called time on the drug's run in the U.S. market. The agency placed Intercept's trials of obeticholic acid on a clinical hold and requested that the company voluntarily withdraw the drug from the market, where it has been cleared to treat certain patients with primary biliary cholangitis (PBC) since winning an accelerated approval in 2016. Despite Intercept's arduous efforts to obtain full approval for the drug, the company has obliged and will pull the med, it announced in a Sept. 11 press release. “While our view of Ocaliva’s benefit-risk profile differs from FDA’s, we respect its request and have made this difficult decision to provide clear guidance for patients and prescribers,” Intercept’s U.S. president Vivek Devaraj said in a statement. “We remain committed to innovation in hepatology and to serving the needs of patients and physicians.”The development marks the latest setback for Intercept's U.S. market prospects and comes after the FDA’s Gastrointestinal Drug Advisory Committee overwhelmingly voted against Intercept's data package at a meeting last year.Committee members weren’t swayed by Intercept’s clinical trials, nor was the FDA in its pre-meeting briefing documents. In its assessment, the FDA flagged the potential for the drug to put patients at greater risk of needing a liver transplant or death.Soon after the meeting, the FDA rejected Intercept’s bid for a traditional approval. But the agency did allow the drug to remain available for certain patients under its initial accelerated nod while it weighed safety data from a post-marketing study. Still, the company didn’t give up and pledged to generate additional data in support of its drug.But the hits kept on coming. Over in Europe, regulators ultimately snatched back Ocaliva’s marketing nod late last year after a holding period. The repeated setbacks in PBC weren't exactly unfamiliar territory for Intercept. The company had at one point hoped to market the drug as the first treatment for nonalcoholic steatohepatitis, which is now known as metabolic dysfunction-associated steatohepatitis (MASH).That situation saw a similar storyline play out, with two of the company's attempts to win the FDA’s favor falling short. Afterward, Intercept was forced to pivot from its MASH efforts to PBC, trimming a third of its workforce and winding down all MASH-related investments. It was after the MASH rejection that Intercept sold itself to Italian drugmaker Alfasigma in a deal worth about $800 million. At the time in 2023, the company was boasting $285.7 million in full-year 2022 sales for Ocaliva, its lone product.Intercept’s pipeline is made up largely of obeticholic acid, but it lists one other next-generation FXR agonist being tested in a phase 2a study for severe alcohol-associated hepatitis.