US clinical-stage liver disease focused biotech Akero Therapeutics (Nasdaq: AKRO) saw its shares almost double to $51.71 yesterday, after it released positive preliminary top-line week 96 results from SYMMETRY.
The Phase IIb study evaluated 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).
Akero noted that, 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).
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