By Colin Kellaher
Akero Therapeutics shares lost two-thirds of their value and fell to a 52-week low on Tuesday after the biotechnology company said a Phase 2b study of lead product candidate efruxifermin missed its key goal in nonalcoholic steatohepatitis, the chronic liver condition known as NASH.
Shares of the South San Francisco, Calif., company were recently trading at $15.65, down nearly 68%, after touching a 52-week low of $15.48 earlier in the session.
Akero said the Phase 2b study of patients with compensated cirrhosis due to NASH showed a trend toward the primary endpoint of fibrosis improvement but didn’t reach statistical significance.
Akero’s study miss also weighed on shares of 89bio, which is studying a NASH drug that, like efruxifermin, mimics a metabolic hormone called FGF21.
89bio shares were recently changing hands at $10.10, down 35%.
There are no FDA-approved drugs to treat NASH, which is caused by a buildup of fat in the liver and is estimated to affect 17 million Americans. Only half of patients with cirrhosis due to NASH survive beyond five years unless they receive a transplant, Akero said.
Chief Executive Andrew Cheng said Akero had “set a high bar with the primary endpoint after only 36 weeks of treatment,” and that based on the totality of the study data, the company believes efruxifermin has the potential to show additional improvements for patients after a long-term follow-up period is complete at 96 weeks.
In a research note, SVB Leerink analysts Thomas Smith and Nat Charoensook said that despite the miss on the primary endpoint, Akero’s study produced the strongest efficacy dataset reported to date in a difficult-to-treat patient population, and that the selloff in Akero and 89bio shares is overdone. The analysts have an outperform rating on 89bio but don’t cover Akero.
Write to Colin Kellaher at [email protected]
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