Akero Therapeutics Announces Publication of Phase 2b SYMMETRY Cohort D Study in Clinical Gastroenterology and Hepatology

As reported previously, the addition of EFX to GLP-1 receptor agonist therapy had a safety and tolerability profile comparable to that of EFX alone and led to statistically significant improvements in non-invasive markers of liver injury and fibrosis and of metabolic health

Results indicate potential of EFX to improve resolution of steatohepatitis and fibrosis for patients with MASH and type 2 diabetes already taking a GLP-1 receptor agonist

SOUTH SAN FRANCISCO, Calif., March 07, 2024 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease, today announced publication of results in Clinical Gastroenterology and Hepatology from an expansion cohort (Cohort D, N=31) of the Phase 2b SYMMETRY study.

The publication, available online, reports results of the 12-week study to assess safety and tolerability of efruxifermin (EFX) compared to placebo when added to a stable dose of GLP-1 receptor agonist (GLP-1RA) in patients with Type 2 diabetes (T2D) and F1-F3 liver fibrosis due to metabolic dysfunction-associated steatohepatitis (MASH), formerly known as NASH.

Tolerability of EFX on top of GLP-1RA (N=21 patients) was generally comparable to GLP-1RA alone (placebo, N=10). The most frequent adverse events for EFX-treated patients were grade 1 or 2 gastrointestinal events (diarrhea, nausea, and increased appetite). One patient treated with EFX discontinued due to nausea and one EFX-treated patient withdrew consent prior to Week 12. There were no drug-related serious adverse events. The overall tolerability profile was similar to that observed in Akero’s prior BALANCED and HARMONY studies in patients with MASH (F1-F3). Patients treated with EFX plus GLP-1RA showed a similar mean weight loss from baseline relative to patients treated with GLP-1RA alone.

Non-invasive markers of liver health showed clinically meaningful improvements following treatment for 12 weeks with EFX plus GLP-1RA compared to GLP-1RA alone (placebo). Notably, liver fat was reduced from baseline by 65% for EFX on top of GLP-1RA compared to a 10% relative reduction for GLP-1RA alone, with levels normalized (5% absolute) in almost 90% of patients receiving EFX plus GLP-1RA compared to 10% of those receiving GLP-1RA alone. In addition, patients treated with EFX plus GLP-1RA (N=21) had greater improvements in non-invasive markers of liver injury (ALT and AST) and fibrosis (Pro-C3 and ELF), than those receiving GLP-1RA alone (N=10). Markers of glycemic control and lipid metabolism were also improved more with EFX plus GLP-1RA than GLP-1RA alone, reflecting the complementary insulin-sensitizing action of EFX when combined with an insulin secretagogue such as GLP-1RA.