Phase IIB Results for Efruxifermin
Akero Therapeutics, Inc. released preliminary topline week 96 results from SYMMETRY, a Phase IIb study evaluating the efficacy and safety of its lead product candidate efruxifermin (EFX) in patients with biopsy-confirmed compensated cirrhosis (F4), Child-Pugh Class A, due to metabolic dysfunction-associated steatohepatitis (MASH)
Among patients with baseline and week 96 biopsies (n=134), 39% of patients treated with 50mg EFX (n=46) (p=0.009) experienced reversal of cirrhosis with no worsening of MASH, compared to 15% for placebo (n=47). In the Intent to Treat (ITT) population (n=181), with all missing week 96 biopsies treated as failures, 29% of patients in the 50mg EFX group (n=63) (p=0.031) experienced reversal of cirrhosis with no worsening of MASH, compared to approximately 12% in the placebo group (n=61).
In a subgroup of patients with baseline and week 96 biopsies who were not taking GLP-1 at baseline (n=97), 45% in the 50mg EFX group experienced reversal of cirrhosis with no worsening of MASH (n=29) (p=0.009) compared to 17% for placebo (n=36), suggesting that the observed reversal of cirrhosis was not attributable to GLP-1 therapy.
According to the, press release, 39% of patients with baseline and week 96 biopsies who were treated with efruxifermin 50 mg experienced reversal of cirrhosis with no worsening of MASH, compared to 15% for placebo (P = .009). In the intent-to-treat (ITT) population with all missing week 96 biopsies treated as failures, 29% of patients in the 50 mg efruxifermin group experienced reversal of cirrhosis with no worsening of MASH, compared to approximately 12% in the placebo group (P = .031). “Until today, we’ve not had the prospect of an effective treatment for compensated cirrhosis due to MASH, which is associated with high rates of short-term morbidity and mortality,” Mazen Nourredin, MD, a professor of medicine and transplant hepatologist at Houston Methodist Hospital, and principal investigator for the SYMMETRY study, said in a press release “Now we have reason to be optimistic about the future potential of EFX as a much-needed treatment for cirrhosis, if approved. I’m so happy for my patients and patients all around the world."
.Although resmetirom (Rezdiffra) is currently the only FDA-approved MASH therapeutic, it is only indicated for patients with MASH and moderate to advanced fibrosis, representing a lingering unmet need for those with MASH and cirrhosis.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.