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.
The U.S. FDA’s release of its briefing document for the upcoming advisory committee meeting on obeticholic acid 25 mg as a fatty liver disease treatment sent Intercept Pharmaceuticals Inc. on a downwards spiral May 17. Soon after the document was released, Intercept stock (NASDAQ:ICPT) dropped as low as $11.41 – down almost 30% from its May 16 close of $16.21. As the day wore on, it regained some of that lost value in heated trading that was more than eight times the company’s average daily volume of 782,285. The rebound helped Intercept close the day at $13.83, down about 15%.
Hefei Tianhui Incubator of Technologies Co. Ltd. (HTIT)’s NDA for recombinant human insulin capsule ORMD-0801 for type 2 diabetes is under review by the NMPA and, if approved, is expected to be the first oral insulin available in China, where regulators have been on the lookout for new treatment options for the increasingly common disease.
Hefei Tianhui Incubator of Technologies Co. Ltd. (HTIT)’s NDA for recombinant human insulin capsule ORMD-0801 for type 2 diabetes is under review by the NMPA and, if approved, is expected to be the first oral insulin available in China, where regulators have been on the lookout for new treatment options for the increasingly common disease.
Therabest Co. Ltd. has identified glutathione (GSH) or hydrogen peroxide (H2O2)-activated prodrugs comprising obeticholic acid dimers conjugated via linkers and their nanogels coated with fucoidan reported to be useful for the treatment of liver diseases.
