Akero-Therapeutics-Completes-Enrollment-of-Phase-2b-SYMMETRY-Study-and-Announces-Expected-2023-Milestones.htmlv
Results of the main study in patients with compensated cirrhosis due to NASH (F4) expected in fourth quarter of 2023
Results of the cohort D expansion to evaluate EFX in combination with GLP-1 therapy in patients with pre-cirrhotic NASH expected in second quarter of 2023
Following designation of EFX as a Breakthrough Therapy, a meeting has been scheduled for March 2023 with FDA to review results of the Phase 2b HARMONY study and to obtain feedback on a proposed Phase 3 clinical program
Excerpt from the Press Release:
SOUTH SAN FRANCISCO, Calif., Dec. 21, 2022 (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, today announced that it has completed enrollment of the Phase 2b SYMMETRY main study evaluating efruxifermin (EFX) for the treatment of non-alcoholic steatohepatitis (NASH), in patients with compensated cirrhosis fibrosis stage 4 (F4). Enrollment is also complete for the expansion cohort, known as Cohort D, evaluating EFX in combination with GLP-1 therapy in patients with fibrosis stage 1-3 (F1-F3) and Type 2 Diabetes Mellitus (T2D).
“We are encouraged by the strength of our EFX data to date, including histology data from a Phase 2a proof-of-concept study in patients with cirrhosis due to NASH, and believe EFX has the potential to show favorable histology results in the SYMMETRY main study despite other investigational drugs having shown limited efficacy,” said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero. “We look forward to reporting SYMMETRY data later next year as we evaluate EFX’s potential to slow or reverse progression of cirrhosis.”
The Phase 2b SYMMETRY main study is a multicenter, randomized, double-blind, placebo-controlled, clinical trial in biopsy-confirmed NASH patients with compensated cirrhosis (F4, Child-Pugh class A). One hundred eighty-two patients have been randomized to receive once-weekly subcutaneous dosing of 28mg EFX, 50mg EFX, or placebo. The primary endpoint for the trial is fibrosis regression after 36 weeks treatment.
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