NGM Biopharmaceuticals' phase 2b trial evaluating aldafermin in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH) with liver fibrosis has failed to meet its primary endpoint — and the company has pulled the plug on the phase 3 trial plans.
According to the California-based biotech, the ALPINE 2/3 study of 171 patients did not meet its primary endpoint evaluating a dose response showing improvement in liver fibrosis by >1 stage with no worsening of NASH at week 24. The study did achieve statistical significance versus placebo on certain secondary endpoints, including NASH resolution and multiple non-invasive measures of NASH.
“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.
In light of the failure to meet the primary endpoint, NGM has decided to shift the resources that had previously been reserved for a phase 3 NASH development program, including a cash balance in excess of $400 million, toward advancing other programs.
Read the press release
