(Reuters) -Akero Therapeutics said on Tuesday its lead drug missed the main goal in a mid-stage trial treatment of patients with a severe type of fatty liver disease, sending its shares tumbling 63% in premarket trading.
About 22-24% of the patients with nonalcoholic steatohepatitis (NASH) with severe liver scarring who were given the drug, efruxifermin, experienced at least one stage of improvement at the end of 36 weeks depending on the dosage, compared to 14% of patients with placebo.
But the results were not statistically significant, the company said.
The 153-patient trial, however, met secondary goals, with 63% of patients who were given the lower dose and 60% of those on higher dose experiencing resolution of NASH symptoms, compared to 26% of those on placebo.
Akero’s drug has shown promise so far. Up to Monday’s close, the company’s shares had gained 67% since September last year, when it reported results from another mid-stage study in which it was testing the drug in NASH patients who did not have liver scarring.
The company had in June also reported positive data for trial of the drug in NASH patients with diabetes.
Following Akero’s failure to meet its main trial goal in patients with severe NASH, shares of 89Bio, which is developing a drug in the same class as efruxifermin, also fell 29% in premarket trading.
On the other hand, shares of Madrigal Pharmaceuticals rose 7%. The company is the frontrunner for the U.S. Food and Drug Administration’s approval for the first drug to treat NASH, a disease which affects about 5% of adults in the U.S. but has no approved treatments.
(Reporting by Leroy Leo and Bhanvi Satija in Bengaluru; Editing by Arun Koyyur)
