Akero Therapeutics (NASDAQ:AKRO) jumps +43% AH, after the company announce results of a 16-week analysis of secondary and exploratory endpoints from its Phase 2a BALANCED study of its lead candidate efruxifermin (EFX), formerly known as AKR-001, in nonalcoholic steatohepatitis (NASH) patients.
Of the 40 responders who had end-of-treatment biopsies, 48% achieved at least a one-stage improvement in fibrosis without worsening of NAFLD activity score across all dose groups. 28% achieved at least a two-stage improvement in fibrosis.
Also, 48% of responders achieved NASH resolution with no worsening of liver fibrosis (scarring).
Improvements in glycemic control and dyslipidemia (elevated cholesterol or fats in the blood), as well as weight loss, were also observed across all dose groups.
On safety front, EFX was generally well tolerated, and there were two Serious Adverse Events, one of which occurred prior to dosing; the most frequent AEs were mild to moderate gastrointestinal events, which were transient in nature
The company previously reported that each of the 28, 50 and 70 mg EFX dose groups met the primary endpoint compared to placebo.
AKR-001 is an engineered human Fc-FGF21 fusion protein designed to induce the benefits of the endogenous hormone FGF21 which can potentially reduce liver fat, mitigate inflammation and reverse fibrosis. It is administered once per week via subcutaneous injection.
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