Akero Therapeutics to Present Topline Week 96 Results from Phase 2b HARMONY Study Investigating Efruxifermin in Patients with Pre-Cirrhotic MASH

Investor webcast on Monday, March 4 at 8:00 a.m. ET to present clinical data

SOUTH SAN FRANCISCO, Calif., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease, will hold an investor conference on Monday, March 4 at 8:00 a.m. ET to share results after 96 weeks of treatment for its HARMONY study, a double-blind, placebo-controlled Phase 2b study evaluating the efficacy of efruxifermin (EFX) in patients with pre-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH), fibrosis stage 2 or 3 (F2-F3).

Conference Call / Webcast Details
The company will host a conference call and webcast with slide presentation at 8:00 a.m. ET on Monday, March 4. Please click here to register for the event. The live webcast will be available on the Events & Presentations page of the Akero website, with the recording and presentation available immediately following the event.

About HARMONY
The Phase 2b HARMONY study was a multicenter, randomized, double-blind, placebo-controlled, dose-ranging trial in biopsy-confirmed adult patients with pre-cirrhotic MASH (F2-F3). The study enrolled a total of 128 patients, randomized to receive once-weekly subcutaneous dosing of 28mg or 50mg EFX, or placebo. The primary efficacy endpoint for the study was the proportion of subjects who achieved at least a one-stage improvement in fibrosis without worsening of MASH at week 24. Week 96 histology endpoints included the proportion of subjects who achieved at least a one-stage improvement in fibrosis without worsening of MASH, a two-stage improvement in fibrosis without worsening of MASH, MASH resolution without fibrosis worsening, and a combination of fibrosis improvement and MASH resolution. Additional secondary measures included change from baseline for noninvasive markers of liver fibrosis, liver enzymes, markers of glycemic control, lipoproteins and body weight as well as safety and tolerability measures.

In September 2022, Akero reported positive results from the study after 24 weeks of EFX treatment, demonstrating both the 50mg and 28mg EFX doses achieved statistical significance on the primary endpoint as well as secondary histology endpoints. 41% and 39% of patients treated with 50mg and 28mg EFX, respectively, experienced at least a one-stage improvement in liver fibrosis with no worsening of MASH by week 24, approximately double the placebo rate of 20%. 76% and 47% of patients treated with 50mg and 28mg EFX, respectively, experienced MASH resolution without worsening of fibrosis, three to five times the placebo rate of 15%. 41% and 29% of patients treated with 50mg and 28mg EFX, respectively, experienced both MASH resolution and fibrosis improvement ≥1 stage, approximately six to eight times the placebo rate of 5%. EFX-treated patients also experienced statistically significant improvements in liver fat, liver enzymes, noninvasive markers of fibrosis, glycemic control, lipoproteins, and body weight. EFX was reported to be generally well-tolerated. Across both dose groups, the most frequent adverse events were grade 1 or 2 gastrointestinal events (diarrhea, nausea, increased appetite, and frequent bowel movements), which were transient in nature.