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Akero's NASH Candidate Shows Substantial Liver Fat Reductions After Four Months Of Treatment

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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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