==Akero's (AKRO) drug for fatty liver disease misses main trial goal

 

Oct 10 (Reuters) - Akero Therapeutics said on Tuesday its drug to treat a type of fatty liver disease showed improvement in patients in a mid-stage trial, but the data showed that the results were not statistically significant. 

Akero Therapeutics reports encouraging 36-week analysis of 96-week phase 2b symmetry study, with a trend on fibrosis improvement and statistically significant results for nash resolution, markers of liver injury and fibrosis, insulin sensitization and lipoproteins 

• A trend was observed for the primary endpoint of fibrosis improvement at 36 weeks, with 22% and 24% of the 28mg and 50mg EFX-treated groups, respectively, experiencing at least a one-stage improvement in liver fibrosis and no worsening of NASH, compared with 14% for placebo. In addition, 4% of patients in each of the EFX-treated groups experienced a three- or two-stage fibrosis improvement without worsening of NASH -- from compensated cirrhosis (F4) to F1 or F2, compared with 0% for placebo.
• Statistically significant rates of NASH resolution in 63% and 60% of patients at week 36 were observed for the 28mg and 50mg EFX-treated groups, respectively, compared with 26% for placebo, representing the highest response rates reported to date for NASH resolution in this patient population. Statistically significant improvements were also observed for both EFX groups in non-invasive markers of liver injury and fibrosis, insulin sensitization and lipoproteins.

Akero Therapeutics to Present Results from Phase 2b SYMMETRY Study Investigating Efruxifermin in Patients with Compensated Cirrhosis Due to NASH

SOUTH SAN FRANCISCO, Calif., Oct. 09, 2023 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease marked by high unmet medical need, will hold an investor conference on Tuesday, October 10 at 8:00 a.m. ET to share topline week 36 results from its SYMMETRY study, a double-blind, placebo-controlled Phase 2b study evaluating the efficacy of efruxifermin (EFX) in patients with compensated cirrhosis due to non-alcoholic steatohepatitis (NASH). The topline results will include histology and changes from baseline in non-invasive measures of fibrosis, glycemic control, and lipoproteins as well as safety and tolerability.