The trial’s primary efficacy endpoint was the proportion of subjects who achieved at least one stage of fibrosis improvement by week 26, without the worsening of MASH. Credit: Emily frost/Shutterstock.

Akero Therapeutics has revealed preliminary topline week 96 outcomes from its Phase IIb SYMMETRY study of efruxifermin (EFX) in individuals with biopsy-confirmed compensated cirrhosis (F4), Child-Pugh Class A, due to metabolic dysfunction-associated steatohepatitis (MASH).

The placebo-controlled, multicentre, double-blind, dose-ranging, randomised trial involved adult subjects with this condition.

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Its primary efficacy endpoint was the proportion of subjects who achieved a minimum fibrosis improvement of one stage by week 36, without the worsening of MASH.

In subjects with baseline and week 96 biopsies, 39% of those treated with a 50mg dosage of the therapy experienced cirrhosis reversal without any worsening of MASH, compared to 15% in the placebo arm, the company noted.

In addition, 29% of subjects receiving the same dosage in the Intent to Treat (ITT) population, where missing week 96 biopsies were considered failures, showed cirrhosis reversal.

The effect size from week 36 to 96 in patients who received the 50mg dose more than doubled.

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In the patient subgroup not taking glucagon-like peptide 1 (GLP-1) at baseline, 45% in the 50mg EFX group reported cirrhosis reversal, compared to 17% for the placebo.

The most frequent adverse events across both EFX groups were gastrointestinal grade 1 or 2 events that were transient in nature.

Akero Therapeutics CEO and president Andrew Cheng  said: “We believe today’s first-ever public report of reversal of cirrhosis due to MASH, whether by completer or ITT analysis, sets EFX apart from other approved or investigational treatments in the MASH landscape as a compound with transformational potential.

“We look forward to continuing evaluation of 50mg EFX in our ongoing Phase III SYNCHRONY Outcomes study in patients with compensated cirrhosis due to MASH.”

With the announcement of these promising results, Akero shares gained 117% in early trading, reported Reuters.

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