Differences between Seres Therapeutics Inc.’s next-generation microbiome therapy and SER-287 were highlighted in the wake of the phase IIb failure with the latter in the study called Eco-Reset, which missed its primary endpoint of improving clinical remission rates in ulcerative colitis (UC) compared to placebo.
Proceeds from Vedanta Biosciences Inc.’s just closed $68 million series D financing will be used for a phase III study of the company’s lead candidate, VE-303, composed of eight clonal human commensal bacterial strains to give colonization resistance for treating Clostridioides difficile (C. diff) infection, and also for a phase II study of VE-202, made up of 16 clonal human commensal bacterial strains for treating inflammatory bowel disease.
Albireo Pharma Inc.’s Bylvay (odevixibat) becomes the first therapy to hit the commercial market for rare genetic liver disease progressive familial intrahepatic cholestasis (PFIC). A day after the European Commission approved the drug, the FDA gave the nod to the ileal bile acid transport inhibitor on its July 20 PDUFA date following a priority review.