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Investing.com -- Shares of Akero Therapeutics, Inc. (Nasdaq: NASDAQ:AKRO) soared 92% following the release of preliminary topline results from its Phase 2b SYMMETRY study, which showed a statistically significant reversal in fibrosis for patients treated with the company's leading drug candidate, efruxifermin (EFX).
The study results, which were publicized on Monday, indicate that 39% of patients treated with a 50mg dose of EFX showed a ≥1 stage improvement in fibrosis without worsening of metabolic dysfunction-associated steatohepatitis (MASH), marking a 24% effect size over the placebo. This effect size increased from 10% to 24% from weeks 36 to 96, highlighting the potential benefits of prolonged EFX treatment.
In the Intent to Treat (ITT (NYSE:ITT)) population, where all missing week 96 biopsies were considered failures, the results were similarly encouraging, with 29% of patients in the 50mg EFX group experiencing a reversal of cirrhosis compared to approximately 12% in the placebo group.
The study's primary investigator, Mazen Nourredin, M.D., expressed optimism about EFX's potential as a treatment for cirrhosis due to MASH, noting the absence of effective treatments for the condition, which is associated with high morbidity and mortality rates.
Akero Therapeutics' CEO, Andrew Cheng, M.D., Ph.D., emphasized the significance of these findings, stating that the report of cirrhosis reversal sets EFX apart in the MASH treatment landscape and could represent a transformative advancement.
Improvements were also observed in key noninvasive measures of liver fibrosis and injury, with patients in the 50mg EFX group exhibiting meaningful reductions in ELF score and liver stiffness, as well as decreases in ALT and AST levels.
The company reported that EFX was generally well-tolerated, with the most frequent adverse events being mild, gastrointestinal in origin, and transient. There were no deaths reported in the EFX groups, and none of the serious adverse events were linked to the study drug.
With these promising results, Akero Therapeutics looks forward to continuing the evaluation of EFX in the ongoing Phase 3 SYNCHRONY Outcomes study in patients with compensated cirrhosis due to MASH. The positive data has clearly resonated with investors, as reflected in the dramatic uptick in the company's stock price.
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