Akero's Drug Meets Main Goal in NASH Trial, Shares Surge 120%

By Leroy Leo

September 14, 2022

(Reuters) - Akero Therapeutics Inc said on Tuesday its lead experimental drug met the main goal of a mid-stage study testing it as a treatment for a type of fatty liver disease that currently has no approved medicine on the market.

The positive data, which needs to be recreated in larger late-stage trials for the drug to be approved, triggered a 120% jump in the company's shares.

Both doses of the drug, efruxifermin, being studied in the trial showed improvement in patients with pre-cirrhotic nonalcoholic steatohepatitis (NASH) by week 24, compared with the placebo arm, according to the company.

It is estimated that about 5% of adults in the United States have NASH, according to the American Liver Foundation, but there is no approved treatment for the ailment.

That could create a big market for drugmakers, with Novo Nordisk as well as smaller companies such as Madrigal Pharmaceuticals Inc and Intercept Pharmaceuticals Inc developing treatments for the disease.

Akero is in talks with both U.S. and European regulators about a late-stage study, which will be started next year after finalizing a trial design, Chief Development Officer Catriona Yale said on a conference call with analysts.

The management also pointed to the drug's better data in treating NASH, compared with rival treatments in the pipeline from companies such as Novo Nordisk, Madrigal and 89bio.

About 40% of the patients in each of the 50 mg and 28 mg dosage groups showed at least a one-stage improvement in liver scarring by week 24, compared with 20% for the placebo arm, Akero said, adding that the study also met its secondary endpoints.

The company expects the data, along with potential weight-reduction benefits seen in the 50 mg dose, to lead to rapid adoption among NASH patients and doctors, Chief Scientific Officer Tim Rolph said.

(Reporting by Leroy Leo in Bengaluru; Editing by Shounak Dasgupta and Anil D'Silva)

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