Akero Therapeutics (AKRO) said Monday that a phase 2b study of its lead product candidate efruxifermin showed a "statistically significant" reversal of compensated cirrhosis caused by metabolic dysfunction-associated steatohepatitis, or MASH.
The company said that among patients with baseline and week 96 biopsies, 39% of those treated with efruxifermin showed reversal of cirrhosis without worsening MASH, compared with 15% for the placebo group. In the intent-to-treat group, 29% of patients treated achieved reversal, compared with about 12% for placebo, the company added.
Efruxifermin was well-tolerated, with no deaths in the treatment groups and most side effects being mild, transient, and gastrointestinal in nature, according to Akero.
The company said it is advancing its evaluation of efruxifermin in an ongoing phase 3 trial.
The company's shares soared past 115% in recent Monday premarket activity.
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