Eli Lilly reported 74% of patients treated with tirzepatide achieved resolution of metabolic dysfunction-associated steatohepatitis, or MASH. However, the Phase 2 results showed only “clinically meaningful” improvement in resolving liver fibrosis, a key measure of the drug's potential competitiveness in a crowded field of contenders.
Intercept Pharmaceuticals’ acquisition by Alfasigma comes three months after the FDA again rejected the biotech’s drug as a treatment for the fatty liver disease NASH. But Intercept still has rare liver disease assets, and Italy-based Alfasigma says acquiring the company will help it expand in gastroenterology and hepatology.
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Inflammation and immunology biotech Apogee Therapeutics and Sagimet Biosciences, a company developing a drug for the fatty liver disease NASH, are the latest biotech companies to join the public markets. Both companies upsized their IPOs, raising cash for clinical trials.
A Madrigal Pharmaceuticals drug for the fatty liver disease NASH has data from a pivotal clinical trial showing improvements in the organ. Based on those results, which sent Madrigal's stock price soaring more than 200%, the biotech is planning to seek what could become the first regulatory approval of a therapy for this metabolic disorder.
Ipsen is paying €120 million up front to acquire global rights to elafibranor, a Genfit drug that fell short as a treatment for NASH, but is currently in Phase 3 testing in another liver disease, primary biliary cholangitis. Meanwhile, Genfit is adding an early-stage drug candidate to its own pipeline via a separate transaction.
GlaxoSmithKline sees enough promise in the early clinical data of a novel NASH drug to pay its developer, Arrowhead Pharmaceuticals, $120 million up front for rights to the experimental therapy. The Arrowhead drug uses RNA interference to “silence” an enzyme associated with the progression of the fatty liver disease.
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Clinical tests of drugs from Gilead Sciences and Novo Nordisk have yielded encouraging results in nonalcoholic steatohepatitis (NASH), and the partners now want to see if the drug combinations help patients in a larger mid-stage study. The planned Phase 2b study expands on a 2019 R&D alliance.
Hanmi will retain options for the drug, efinopegdutide, in Korea under the deal, in which Merck is paying the Seoul-based company $10 million upfront and up to $860 for development, regulatory and commercialization milestones.
The company is hoping to close its seed funding round in the next six months and aims to be in a position to seek regulatory approval for its lead asset, PLX888, in acute alcoholic hepatitis in 2023.
The company said it was formally terminating the Phase III study of the drug elafibranor in NASH and refocus its development of the drug on another disease, primary biliary cholangitis, as well as a diagnostic for NASH.
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The company is developing biosensors, initially for NASH, that could be used in place of liver biopsy and have applicability in development of drugs for the disease.
The FDA has requested additional data from the company's clinical trial. Intercept's CEO expressed disappointment at the decision, saying the agency had not communicated that the drug, obeticholic acid, was not approvable.
The company said that the agency had requested additional data for obeticholic acid and thus pushed the upcoming advisory committee meeting back from June 9, thereby delaying its decision on approval, which had also been scheduled for June 26.
The French drugmaker said Monday that its Phase III study of elafibranor failed to meet its primary and key secondary endpoints. Analysts remarked that this extends the lead of the drug likely to get the first NASH approval, Intercept's obeticholic acid.
These are four companies that currently have drugs in Phase III development for nonalcoholic steatohepatitis or have them under Food and Drug Administration review.