Poor phase II top-line data for Immunic Inc.’s lead candidate, vidofludimus calcium (IMU-838) hammered the stock June 2 as the study of the selective oral DHODH inhibitor missed its primary endpoint of clinical remission in treating moderate to severe ulcerative colitis. The failure means Immunic won’t pursue a phase III study on its own in the indication, but it won’t affect the company’s planned phase III studies of IMU-838 in treating relapsing multiple sclerosis (MS) and a phase II in treating progressive MS.
New and updated preclinical and clinical data presented by biopharma firms at Digestive Disease Week 2022, including: Ardelyx, Ferring, Ironwood, Janssen, Phathom, Rebiotix, Redhill, Second Genome.
Perianal fistulas in Crohn's disease represent a severe complication of the disease. Researchers used a recently established Crohn's perianal fistula rat model to test a novel and proprietary biodegradable nanofiber-hydrogel composite (NHC) loaded with rat adipose-derived stem cells (ADSCs).
Unveiling further positive data for SER-109 in preventing recurrent Clostridium difficile infection at Digestive Disease Week (DDW) over the weekend, Seres Therapeutics Inc. reiterated plans to file a BLA with the U.S. FDA in mid-2022. Should the FDA accept the application and grant priority review – SER-109 has breakthrough and orphan status – the medicine could be the first microbiome-based therapy to reach the market.
New and updated preclinical and clinical data presented by biopharma firms at Digestive Disease Week 2022, including: Albireo, Cymabay, Evoke, Fractyl, Seres.
Sosei and Kallyope have entered a strategic research collaboration to identify and validate novel G protein-coupled receptor (GPCR) targets with a goal of creating new drug discovery programs in the area of gastrointestinal diseases.