Akero Therapeutics Reports Positive Phase 2b HARMONY Study Data

DENVER, Colo., Mar 04, 2024 (247marketnews.com)- Akero Therapeutics, Inc. (NASDAQ:AKRO) released, this morning, its preliminary topline week 96 results from HARMONY, a Phase 2b study evaluating the efficacy and safety of its lead product candidate efruxifermin (EFX) in patients with pre-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH), fibrosis stage 2 or 3 (F2-F3).

Akero is trading at $33.52, up $5.71 (+20.53%) on trading volume of 446K shares

Its 52-week range is $11.25 to $58.38. It has a gap to the $45 level and this morning’s premarket high is $56.10.

“Notwithstanding inherent limitations in making cross-trial comparisons, the statistically significant results for ≥1- and 2-stage fibrosis improvement and no worsening of MASH observed for 50mg EFX at week 96 are the largest response rates reported publicly to date for these endpoints in any MASH population,” said Stephen Harrison, M.D., medical director of Pinnacle Clinical Research and the HARMONY study’s principal investigator. “I believe the magnitude and general consistency of results observed across the Phase 2a BALANCED and Phase 2b HARMONY studies in patients with pre-cirrhotic MASH are reasons to be optimistic about results of the ongoing Phase 3 SYNCHRONY Histology study and the potential for EFX to be an important MASH medicine, if approved.”

“We believe the statistically significant 2-stage improvement in fibrosis without worsening of MASH observed in approximately one in three EFX-treated patients sets EFX apart,” said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero. “Today’s results show that longer exposure to EFX has the potential to yield sustained fibrosis improvement as well as widening anti-fibrotic treatment responses across the treated patient populations. We look forward to continuing our evaluation of EFX in patients with pre-cirrhotic MASH and cirrhosis due to MASH in our ongoing Phase 3 SYNCHRONY program, in which two out of three studies are actively enrolling.”

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