Akero Therapeutics Completes Enrollment of Phase 2b SYMMETRY Study and Announces Expected 2023 Milestones
December 21 2022 - 04:01PM
GlobeNewswire Inc.
Alert
Print
Share On Facebook
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. Secondary measures include change from baseline in liver enzymes, liver fat, lipoproteins, glycemic control, and body weight at 36 weeks, as well as evaluation of safety and tolerability. To provide additional safety data from long-term follow up, patients will continue to receive EFX or placebo from 36 to 96 weeks.
The primary goal of the 12-week Cohort D expansion, in which 32 patients have been randomized, is to assess safety and tolerability of EFX compared to placebo when added to an existing GLP-1 receptor agonist in patients with T2D and F1-F3 liver fibrosis due to NASH. Demonstrating that EFX could accelerate NASH resolution and reversal of fibrosis among those patients already on GLP-1 therapy would help address an important unmet medical need.
Consistent with prior guidance, results from the Cohort D expansion cohort are expected in the second quarter of 2023, while results from the main study remain on track to be reported in the fourth quarter of 2023.
Following designation of EFX as a Breakthrough Therapy by the FDA, an End-of-Phase 2 meeting has been scheduled for March 2023 to review the HARMONY F2/3 data as well as the proposed Ph3 clinical program.
About NASH
NASH (non-alcoholic steatohepatitis) is a serious form of NAFLD (non-alcoholic fatty liver disease) that is estimated to affect 17 million Americans. NASH is characterized by an excessive accumulation of fat in the liver that causes stress and injury to liver cells, leading to inflammation and fibrosis, which can progress to cirrhosis, liver failure, cancer and eventually death. There are no approved treatments for the condition and NASH is a leading cause of liver transplants in the US and Europe.
About Efruxifermin
Efruxifermin (EFX), formerly known as AKR-001, is Akero’s lead product candidate for NASH, currently being evaluated in the ongoing Phase 2b HARMONY and SYMMETRY studies. EFX is designed to reduce liver fat and inflam
