Three years after stopping development in nonalcoholic steatohepatitis, Genfit SA and partner Ipsen Pharma SA have announced positive phase III data for elafibranor in the treatment of primary biliary cholangitis (PBC) and are preparing to file for U.S. FDA and EMA approval.
Nonalcoholic steatohepatitis (NASH) is the most severe form of nonalcoholic fatty liver disease, where in addition to the accumulation of fat in the liver, there is also chronic inflammation and hepatocyte injury. With no therapy approved yet, selective thyroid hormone receptor-β (THR-β) agonism has yielded good results in ongoing clinical development.
Primary sclerosing cholangitis (PSC) and nonalcoholic steatohepatitis (NASH) are chronic inflammatory liver diseases. It is known that one of the cell signaling molecules overexpressed in the liver during inflammation is IL-18, which is also a marker of hepatocyte injury and liver steatosis.
Intercept Pharmaceuticals Inc.’s second attempt to score an expanded U.S. FDA approval of its farnesoid X receptor agonist, obeticholic acid, in patients with non-alcoholic steatohepatitis (NASH) went the way of the first, with the agency issuing another complete response letter (CRL), prompting the company to drop all NASH-related investment and cut a third of its workforce.
At the ongoing EASL meeting, researchers from Hepagene Therapeutics Inc. presented preclinical data for the novel thyroid hormone receptor β (THR-β) agonist HPG-7233, being developed for the treatment of nonalcoholic steatohepatitis (NASH).
Patients with nonalcoholic fatty liver disease (NAFLD) and type 2 diabetes had a 44% reduction in liver fat after receiving Inventiva Pharma SA’s PPAR agonist, lanifibranor, in a phase II trial, findings that caused the Daix, France-based company’s stock to soar.
Liminal Biosciences Inc. has nominated a lead preclinical candidate, LMNL-6326, from its oxoeicosanoid receptor 1 (OXER1) antagonist program, targeting the treatment of eosinophil-driven diseases such as eosinophilic asthma and atopic dermatitis.
Researchers from the Chinese Academy of Medical Sciences and Peking Union Medical College presented the discovery and preclinical evaluation of farnesoid X receptor (FXR) antagonists.
Trouble presaged by U.S. FDA concerns over potential drug-induced liver injury (DILI) caused by obeticholic acid (OCA) 25 mg came to pass during the Gastrointestinal Drugs Advisory Committee meeting May 19 on Intercept Pharmaceuticals Inc.’s accelerated approval effort with the compound.
Currently, there is no FDA-approved drug for nonalcoholic steatohepatitis (NASH), which has evolved into the second leading cause of liver transplantation in the U.S. Researchers from Children’s Hospital Los Angeles and Epigen Biosciences Inc. disclosed preclinical data on EPGN-2154, a novel lysophosphatidic acid LPA1 receptor agonist that has already demonstrated antifibrotic activity in preclinical kidney and liver models.
