NGM Biopharmaceuticals Inc. wowed investors with positive preliminary top-line results from the 24-week double-blind, randomized, placebo-controlled fourth cohort of an adaptive phase II study testing aldafermin in nonalcoholic steatohepatitis (NASH).
LONDON – Northsea Therapeutics BV has closed a $40 million series B, providing the means to complete the ongoing U.S. phase IIb trial of its lead product for treating nonalcoholic steatohepatitis (NASH) and to launch clinical trials of two more products.
PERTH, Australia – Boehringer Ingelheim GmbH is discontinuing development of BI-1467335 for the treatment of nonalcoholic steatohepatitis (NASH) that it acquired from Sydney-based Pharmaxis Ltd. in 2015.
BOSTON – For diagnosing nonalcoholic steatohepatitis (NASH), liver biopsy is "the reference standard," Dean Hum, president of Genfit Corp., told BioWorld. "I'm not going to call it the gold standard." Some of the reasons for denying biopsies a gold sticker are obvious. Biopsies are invasive, which makes them risky, expensive and loathed by patients and doctors alike. "In the real world, doctors don't always do biopsies – many say they very rarely do biopsies unless other data points in several directions and they need that for clarity," Gail Cawkwell told BioWorld.
BEIJING – Hightide Therapeutics Inc., of Shenzhen, China, and Rockville, Md., said it finished the enrollment in phase IIa trials for its lead asset, HTD-1801, which is a potential first-in-class new molecular entity for primary sclerosing cholangitis (PSC) and nonalcoholic steatohepatitis (NASH).
Investors sorting through NGM Biopharmaceuticals Inc.'s interim results from the fourth and final cohort of the adaptive phase II trial with aldafermin in nonalcoholic steatohepatitis (NASH) may have felt let down when comparing the data to previous cohorts' outcomes. Shares of the South San Francisco-based firm (NASDAQ:NGM) closed Monday at $10.78, having sunk $2.77 or 20.4%.
Top-line results from Enanta Pharmaceuticals Inc.'s Argon-1 phase IIa study of EDP-305 for the treatment of nonalcoholic steatohepatitis (NASH) found one of the two doses of the drug tested met the study's primary endpoint, alanine aminotransferase (ALT) reduction at week 12, contributing further evidence for the drug's mechanism of action, farnesoid X receptor (FXR) agonism. But the non-biopsy study appears to have left investors without proof for something more even more valuable: a clear case for differentiation vs. FXR first-mover Ocaliva (obeticholic acid, Intercept Pharmaceuticals Inc.). Appearing to reflect the sentiment, Enanta's shares (NASDAQ:ENTA) fell 15.1% to $60.51 on Thursday.