The Akero Therapeutics Inc (NASDAQ: AKRO) stock price plunged 64%+ after the company faced a significant setback in developing a nonalcoholic steatohepatitis (NASH) treatment candidate.
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The failure of the company’s FGF21 analog, efruxifermin (EFX), to achieve a substantial reduction in fibrosis among cirrhotic NASH patients led to a sharp decline in Akero’s stock value, causing a ripple effect that negatively impacted a competitor’s share price as well.
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Akreo, based in San Francisco, has gained recognition as a frontrunner in the NASH research field over the past 13 months. In September 2022, the biotech made headlines by linking EFX to reduced fibrosis, primarily in patients with significant or advanced fibrosis but without cirrhosis.
In June, Akero followed up with data suggesting that EFX might complement the GLP-1 drugs that are transforming the treatment of obesity.
However, recent developments have taken an unexpected turn. Akero, having demonstrated efficacy in earlier-stage patients, had high hopes for its phase 2b SYMMETRY clinical trial to confirm that EFX could reduce fibrosis in individuals with compensated cirrhosis. Unfortunately, the study did not meet expectations.
After 36 weeks, only 24% of patients on the high EFX dose experienced at least a one-stage improvement in liver fibrosis without worsening NASH, compared to 14% of those on a placebo.
The low EFX dose performed slightly worse, with 22% of patients meeting the response criteria. Neither dose significantly outperformed the placebo, although Akero did report improvements in NASH resolution and markers of liver injury.
Stephen Harrison, M.D., founder and chairman of Pinnacle Clinical Research and Akero’s SYMMETRY study’s principal investigator, said: “Although no head-to-head comparative studies have been conducted, and despite the short treatment with EFX, the week 36 SYMMETRY results are the strongest data set reported to date in a placebo-controlled trial in the difficult-to-treat population of patients with cirrhosis due to NASH. Patients with cirrhosis have high levels of hepatic collagen, and this takes time to resorb even though synthesis of collagen was rapidly and substantially reduced by EFX. I’m encouraged that statistically significant improvements in multiple measures of NASH pathogenesis were observed in EFX-treated patients.”
Akero Therapeutics (AKRO) stock price.
The Akero Therapeutics (AKRO) stock price plunged 64.01% to trade at $17.47 from Monday’s closing price of $48.52
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