NGM Biopharmaceuticals, Inc. (NASDAQ: NGM) announced results from its 24-week phase 2b study  that aveluates aldafermin in 171 patients with biopsy confirmed non-alcoholic steatohepatitis with state 2 or 3 liver fibrosis. The trial was randomized, double blind, placebo controlled study that assessed the efficacy, tolerability and safety of 0.3 mg, 1 mg and 3mg doses of aldafermin once-daily injections compared to placebo. The study did not meet its primary end point. “These results are certainly disappointing, particularly given the dire unmet need in this patient population. The lack of significant fibrosis improvement was unexpected given the consistency of histology findings previously seen with aldafermin in our adaptive four-cohort Phase 2 study,” said David J. Woodhouse, Ph.D., Chief Executive Officer at NGM. “However, in line with the data from that study, ALPINE 2/3 achieved statistical significance on multiple non-invasive measures of NASH at the two higher doses. That said, given the failure to meet the primary endpoint, we have decided to shift resources that had previously been reserved for a Phase 3 F2/F3 NASH development program toward advancing our other programs.”
Dr. Woodhouse further commented, “NGM is a markedly different company than when we initiated ALPINE 2/3 in May 2019, when our clinical-stage pipeline consisted primarily of liver and metabolic programs. Over the past two years, we have steadily expanded that pipeline with programs generated from our productive in-house discovery engine, and today we are also an ophthalmology and oncology company with four Phase 2 programs underway. We look forward to advancing our clinical programs and moving additional programs into the clinic, supported by our cash balance that was in excess of $400 million at the end of the first quarter.”
