Sept. 30 Quick Takes: Intercept NASH candidate fails Phase III, NDA resubmission on track

The results of the REVERSE trial did not help reverse the trajectory or sentiment for Intercept Pharmaceuticals Inc. (NASDAQ:ICPT), which fell 15% to $13.95 Friday. The 18-month Phase III study, which enrolled 919 non-alcoholic steatohepatitis (NASH) F4 patients with cirrhosis, did not meet its primary endpoint. Only 11.1% of patients in the obeticholic acid (OCA) 10mg arm and 11.9% of patients treated with OCA 10-to-25mg achieved ≥1-stage histological improvement in fibrosis, vs. 9.9% of patients in the placebo arm. Pruritus was the most common reason for discontinuation and was seen in 31%, 41%, and 57% of patients in the placebo, OCA 10 mg, and OCA 10-to-25 mg arms, respectively. FDA issued a CRL for OCA in NASH in 2020. Based on new data analyses of Phase III REGENERATE trial in F2/F3 NASH patients, Intercept plans to resubmit the NDA by YE22. REVERSE’s failure may further dim the regulatory outlook for OCA in NASH. 

Zealand Pharma A/S (CSE:ZEAL; NASDAQ:ZEAL) said it is planning to submit an NDA for glepaglutide after the long-acting GLP-2 analog met the primary endpoint of a significant reduction in the total weekly volume of parenteral support at 24 weeks compared with placebo in the EASE 1 Phase III trial in patients with short bowel syndrome. At twice-weekly dosing, glepaglutide reduced weekly parenteral support volume by 5.13 liters/week, the company said; when administered once weekly, glepaglutide also reduced parenteral support, but the change was not statistically significant. Zealand is also studying glepaglutide in two long-term extensions, EASE 2 and 3, but did not disclose when those trials would read out...