When it won U.S. FDA accelerated approval more than eight years ago, Intercept Pharmaceuticals Inc.’s Ocaliva (obeticholic acid) was viewed as a breakthrough, becoming the first new treatment in 20 years for rare, progressive liver disease primary biliary cholangitis (PBC) and, for several years, the only second-line treatment for PBC patients failing to respond to ursodeoxycholic acid. More recently, however, Ocaliva has faced regulatory and safety stumbles, with Intercept now voluntarily pulling the farnesoid X receptor activator from the U.S. market.
Lactiga US Inc. has received an award from the NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to advance the development of its secretory IgA (sIgA) antibody for inflammatory bowel disease (IBD).
Metabolic dysfunction-associated steatotic liver disease (MASLD) now affects over a third of adults worldwide. Its progressive form, metabolic dysfunction-associated steatohepatitis (MASH), is a leading driver of cirrhosis, cancer and liver transplants while often coexisting with diabetes, obesity and cardiovascular disease.
The funding is in place for a phase IIb trial of its lead gut microbiome live biotherapeutic, after MRM Health NV closed a €55 million (US$64 million) series B round.
Onco3r Therapeutics BV has obtained clinical trial application (CTA) approval by the Belgian regulatory authorities for its SIK3 inhibitor O3R-5671. A first-in-human trial will be conducted in Belgium and is expected to open enrollment in the coming weeks. Final data are expected in the first half of next year and will inform subsequent patient trials across a range of autoimmune diseases, which are planned to commence next year.
As Wave Life Sciences Ltd. released more results from its ongoing phase Ib/IIa study of small interfering RNA editing oligonucleotide WVE-006 for treating alpha-1 antitrypsin deficiency, the company’s stock (NASDAQ:WVE) dropped by 16.8% to close at $8 on Sept. 3.
Omass Therapeutics Ltd. has entered into an exclusive collaboration and license agreement with Genentech Inc., a member of the Roche Group, for the rights to develop and commercialize Omass’ preclinical oral small-molecule program for inflammatory bowel disease.
Scientists at Emory University and Hadasit Medical Research Services and Development Ltd. have described nuclear receptor ROR-α agonists reported to be useful for the treatment of liver cancer, pancreatitis, diabetes, obesity, immunological disorders, neurological disorders, liver diseases and metabolic diseases, among others.
Beijing Sciwind Biotechnology Co. Ltd. and Sciwind Biosciences Co. Ltd. have divulged glucagon-like peptide 2 receptor (GLP-2R) agonists reported to be useful for the treatment of Crohn’s disease, irritable bowel syndrome, malnutrition, ulcerative colitis, obesity and graft-vs.-host disease.
Gilead Sciences Inc. recently discussed the discovery of emvistegrast (GS-1427), a potent, selective, once-daily oral α4β7 integrin inhibitor currently in phase II trials for the treatment of inflammatory bowel disease (IBD) (NCT06290934).
RSS
