- Akero Therapeutics said Monday adding its experimental NASH medicine to GLP-1 drugs helped to improve markers of the fatty liver disease in a small trial.
- In the Phase 2 study, Akero compared its therapy, known as efruxifermin, together with GLP-1 drugs like Novo Nordisk’s Ozempic against those medicines alone in 31 people with diabetes and NASH, or nonalcoholic steatohepatitis. After 12 weeks of treatment, 88% of participants given the two drugs had achieved normal liver fat levels, compared to 10% of patients who received just a GLP-1 drug.
- GLP-1 drugs have surged in popularity as treatments for Type 2 diabetes and obesity, and are being studied in NASH as well. However, Akero’s data suggest their potential in treating NASH might be amplified by adding other medicines like efruxifermin, which succeeded in a mid-stage liver disease study last year.
NASH is estimated to affect millions of adults in the U.S., but has proven a challenging target for the many drugmakers and smaller biotechnology companies that have sought to develop a therapy for the disease.
That list includes large companies like Gilead, AstraZeneca and GSK. Intercept Pharmaceuticals has come the closest, with the Food and Drug Administration set to decide on approval of its drug in NASH this month. However, its future is uncertain after a key advisory panel in May voted against recommending an OK.
Similarly, obesity was for years difficult to treat with pharmaceuticals until the recent success of GLP-1 agonists like Novo Nordisk’s obesity drug Wegovy and diabetes medicine Ozempic, and Eli Lilly’s Mounjaro, which is approved for diabetes and expected to soon be for weight loss as well.
Akero said its results suggest people taking GLP-1s for diabetes or obesity could be better treated for NASH by adding its drug.
The study data showed efruxifermin paired with a GLP-1 drug led to a 65% relative reduction in liver fat versus baseline measurements, while a GLP-1 drug alone led to a 10% relative reduction. The trial’s main goal was to assess safety and side effects, which for Akero’s drug was mostly nausea. Two treated patients did not complete treatment, one of whom discontinued due to nausea.
According to RBC Capital Markets analyst Brian Abrahams, the study’s small size and some differences between study groups limit how much can be read into the results. “That being said, we believe the directional effects are likely still very clear,” he wrote in a note Monday.
Akero shares climbed about 7%, to nearly $50 apiece, in trading on Monday.