Poxel announces plans for phase 2b trial of AMPK activator for NASH
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Poxel announced additional positive phase 2a results and plans for a phase 2b trial of PXL770, an oral direct adenosine monophosphate-activated protein kinase activator intended for nonalcoholic steatohepatitis.
“There is a sizable overlap in the NASH patient population such that approximately 50% of NASH patients also have co-existing type 2 diabetes. PXL770 is one of the only therapies in development that has demonstrated the potential to treat NASH with specific use in patients with coexisting type 2 diabetes that are at higher risk for faster disease progression and for co-morbidities, including cardiovascular complications,” Pascale Fouqueray, MD, PhD, executive vice president, Clinical Development and Regulatory Affairs at Poxel, said in a press release. “AMPK activation has the potential to improve the underlying root causes of NASH, such as insulin resistance, the dysregulation of lipid and glucose metabolism and inflammation. We believe PXL770 has the potential to be a much-needed and differentiated therapeutic option for NASH and could be particularly important for the high-risk population with type 2 diabetes.”
The STAMP-NAFLD trial was a 12-week randomized study of 120 patients with presumed NASH with or without type 2 diabetes, according to the release. Investigators compared three different dosing regimens of PXL770 with placebo.
Results showed PXL770 at 500 mg once daily resulted in a –27% mean relative decrease in liver fat content (P = .004) compared with baseline results. Researchers also saw clinically meaningful improvements in liver enzymes alanine transaminase (ALT) and AST, fasting glucose and HbA1c among patients with type 2 diabetes treated with PXL770.
PXL770 was safe and well tolerated in patients with type 2 diabetes.
According to new preclinical results, PXL770 produced beneficial effects on the human cells that mediate fibrosis and inflammation.
Next, Poxel will conduct a 52-week phase 2b trial that will assess two doses of PXL770 in up to 120 patients in each arm with NASH and either pre-diabetes or type 2 diabetes. Measuring NASH resolution with no worsening fibrosis will serve as the primary endpoint.