NGM Bio has reported positive results from a Phase II trial of NGM282 to treat non-alcoholic steatohepatitis (NASH) patients.
The results have showed clinically meaningful improvements in histological measures of disease in NASH patients at 12 weeks.
According to a blinded, pooled reading of patient biopsies at baseline and after 12 weeks of therapy, eight of 19 NGM282-treated patients had liver fibrosis improvement by at least one stage from baseline, with three patients demonstrating a two-stage improvement in fibrosis.
After 12 weeks, 84% of patients reportedly saw improvement in their non-alcoholic activity score (NAS), while 58% of patients achieved an improvement in NAS of less than two points with at least one point of improvement in either inflammation or ballooning.
It was also found that NGM282 demonstrated a rapid and strong impact on both fibrosis stage and disease activity as measured by non-alcoholic fatty liver disease (NAFLD) activity score (NAS).
The open-label trial comprises two studies, including a 12‐week, randomised, double‐blind, placebo‐controlled multi-centre study that evaluated the efficacy and safety of daily subcutaneous injections of 3mg NGM282 against placebo in adults with biopsy‐confirmed NASH.
The trial also includes a subsequent 12-week, single-blind expansion study that investigated the efficacy and safety of NGM282 in a similar patient population.
A total of 22 patients were enrolled in the study, while 19 completed the study with paired biopsies, and three withdrew early for reasons unrelated to the drug.
The study principal investigator Stephen Harrison said: “It is unprecedented to see such profound histological improvement in well-established NASH after only 12 weeks of treatment, confirming that NGM282 is potently impacting many clinical dimensions of the disease.
“These data reinforce the potential of NGM282 to resolve disease and reverse fibrosis across a broad range of NASH patients, strongly supporting the continued development of NGM282 in NASH.”
NGM Bio is currently conducting the Phase II expansion study of NGM282 for the treatment of NASH.
The trial’s primary endpoint includes the change from baseline to week 12 in absolute liver fat content (LFC) as measured by MRI-PDFF.
Secondary outcomes included absolute and relative change in LFC at week six and week 12, normalisation of LFC at week 12, changes from baseline and normalisation in ALT levels, changes in lipids and lipoprotein particles and safety and tolerability of NGM282.