SOUTH SAN FRANCISCO, Calif. - Akero Therapeutics, Inc. (NASDAQ: NASDAQ:AKRO), a clinical-stage biopharmaceutical company, announced today positive week 96 results from its Phase 2b HARMONY study. The study evaluated the efficacy and safety of efruxifermin (EFX) in patients with pre-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH), fibrosis stage 2 or 3. The study met its primary endpoint at week 24 and continued to show improvement at week 96.
The results indicated that 75% of patients treated with 50mg EFX and 46% with 28mg EFX showed at least a one-stage improvement in fibrosis without worsening of MASH. These rates are significantly higher than the 24% improvement observed in the placebo group. Additionally, more than 10-fold the placebo rate, 36% of patients on 50mg EFX and 31% on 28mg EFX, experienced a two-stage improvement in fibrosis without worsening of MASH.
Stephen Harrison, M.D., the HARMONY study’s principal investigator, remarked on the significant results, suggesting that the response rates for EFX are the largest reported to date for these endpoints in any MASH population. He expressed optimism about the ongoing Phase 3 SYNCHRONY Histology study and the potential for EFX to become an important MASH medicine.
The study also reported sustained responses in patients who improved at week 24, with 92% in the 50mg EFX group and 83% in the 28mg group remaining responders at week 96, as opposed to 40% for placebo. A subset of patients with more advanced F3 fibrosis also showed promising results, with 68% in the 50mg EFX group and 40% in the 28mg group demonstrating at least a one-stage improvement in fibrosis.
Andrew Cheng, M.D., Ph.D., president and CEO of Akero, emphasized the significance of the sustained fibrosis improvement and the broadening anti-fibrotic treatment responses. The company looks forward to further evaluation of EFX in the ongoing Phase 3 SYNCHRONY program.
EFX was generally well-tolerated, with the most frequent adverse events being mild gastrointestinal issues. Akero plans to report week 96 results from the SYMMETRY study, another Phase 2b trial in patients with compensated cirrhosis due to MASH, in the first quarter of 2025.
The HARMONY study is a randomized, double-blind, placebo-controlled trial that enrolled 128 patients. Its primary efficacy endpoint was the proportion of subjects achieving at least one-stage fibrosis improvement without worsening of MASH at week 24. Secondary measures included additional fibrosis improvements, changes in liver enzymes, and safety and tolerability measures.
This news is based on a press release statement from Akero Therapeutics.
InvestingPro Insights
As Akero Therapeutics (NASDAQ: AKRO) announces promising results from its Phase 2b HARMONY study, investors may be evaluating the company's financial health and market performance. With a focus on the company's recent achievements and future prospects, let's delve into some key metrics and insights from InvestingPro.
The company's market capitalization stands at approximately $1.57 billion, reflecting investor confidence in its potential. Despite not being profitable over the last twelve months, with an adjusted price-to-earnings (P/E) ratio of -10.32, Akero Therapeutics holds more cash than debt on its balance sheet, which is a positive sign for financial stability. This is a critical aspect for a clinical-stage biopharmaceutical company that requires significant capital for research and development.
Akero's stock has seen a significant return over the last week, with a price total return of 16.36%, and an even more impressive return over the last month at 33.64%. Such performance indicates strong market optimism following recent developments, including the HARMONY study results. Two analysts have revised their earnings upwards for the upcoming period, suggesting that the market expects Akero's financial prospects to improve.
Investors interested in a deeper dive into Akero's financials and market performance can find additional InvestingPro Tips at https://www.investing.com/pro/AKRO. There are 11 more tips available, providing a comprehensive analysis of Akero's position and outlook. For those looking to access these insights, use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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