Clinical-stage biotechnology company Akero Therapeutics Inc. (AKRO:NASDAQ), which develops and commercializes treatments for serious metabolic diseases, yesterday announced "results of a 16-week analysis of secondary and exploratory endpoints in its Phase 2a BALANCED study of efruxifermin (EFX), formerly known as AKR-001, in patients with nonalcoholic steatohepatitis (NASH)."
The firm highlighted that "of the 40 treatment responders who had end-of-treatment biopsies, it observed that 48% achieved at least a one-stage improvement in fibrosis without worsening of NAFLD activity score and 28% achieved at least a two-stage improvement in fibrosis."
Stephen Harrison, M.D., medical director of Pinnacle Clinical Research, remarked, "These substantial improvements observed in multiple measures of liver health, particularly the one- and two-stage improvements in fibrosis, are extremely encouraging and among the strongest biopsy results reported in NASH to date...I believe Efruxifermin continues to set itself apart as one of the most promising drug candidates in NASH, with impressive histology results after just 16 weeks of treatment."
Akero Therapeutics' President and CEO Andrew Cheng, M.D., Ph.D., commented, "We believe the BALANCED study data, which exceeded our expectations, demonstrate the strong potential of efruxifermin to be a foundational monotherapy for the treatment of NASH...We look forward to the continued development of efruxifermin and are working diligently to deliver this potentially leading treatment to patients. We are extremely grateful to all of our investigators and study patients, particularly given that this study cohort was completed amidst the COVID-19 pandemic."
The company advised that the BALANCED study is an ongoing clinical trial in NASH patients and that the firm previously reported that several EFX dose groups in the study had met the primary endpoint compared to placebo.
The Phase 2a BALANCED study enrolled a total of 80 patients and was described as "a multicenter, randomized, double-blind, placebo-controlled, dose-ranging trial in biopsy-confirmed adult patients with NASH."
The firm explained that NASH (non-alcoholic steatohepatitis) is a serious form of NAFLD (non-alcoholic fatty liver disease) that is closely linked to obesity and diabetes epidemics observed worldwide. The company stated that NASH affects around 17 million Americans and is a leading cause of liver transplants both in the US and Europe.
The company additionally listed that Efruxifermin (EFX) is its lead product candidate for NASH and "it is designed to reduce liver fat and inflammation, reverse fibrosis, increase insulin sensitivity and improve lipoproteins."
Akero Therapeutics is headquartered in South San Francisco, Calif., and described it business as "a cardio-metabolic NASH company dedicated to reversing the escalating NASH epidemic by developing pioneering medicines designed to restore metabolic balance to improve overall health."
Akero Therapeutics started the trading day with a market capitalization of around $714.6 million with approximately 28.67 million shares outstanding. AKRO shares opened 40% higher today at $35.10 (+$10.18, +40.85%) over yesterday's $24.92 closing price and reached a new 52-week high price this morning of $35.30. The stock has traded today between $31.12 and $35.30 per share and is currently trading at $32.00 (+$7.08, +28.41%).
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