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Akero Therapeutics Inc (NASDAQ: AKRO) has announced full results of the main portion of its Phase 2a BALANCED trial of efruxifermin (EFX) in NASH patients with F1-F3 fibrosis have been published in Nature Medicine.
The manuscript provides a comprehensive analysis showing that pre-cirrhotic NASH patients treated for 16 weeks with EFX achieved substantial reductions in liver fat, associated with decreases in markers of liver injury and inflammation and reversal of fibrosis.
The study met its primary endpoint of absolute change from baseline in hepatic fat fraction measured at week 12, with 48% of EFX patients across dose groups achieving normal liver fat levels, compared with 5% of placebo patients.
The BALANCED study also incorporated a 30-patient expansion cohort in late-stage (F4) cirrhotic NASH. Substantial improvements in fibrosis were evident after 16 weeks of treatment, with 58% of EFX patients meeting one of two key biopsy endpoints.
Specifically, 4 of 12 patients who received 50mg EFX achieved a one-stage improvement in fibrosis without worsening of NASH, and 3 of 12 achieved NASH resolution in each case compared with 0 of 5 placebo patients.
Price Action: AKRO shares are down 0.62% at $23.96 during the market session on the last check Wednesday.
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