Poxel initiates phase 2a study of AMPK activator for NASH

Poxel SA announced initiation of a phase 2a study of PXL770, a direct adenosine monophosphate-activated protein kinase activator for the treatment of non-alcoholic steatohepatitis, according to a company press release.

The study will include approximately 100 patients with nonalcoholic fatty liver disease and suspected NASH who will receive either PXL770 or placebo for 12 weeks. At study end, the investigators will measure the change in liver fat mass based on MRI-PDFF, the effects of PXL770 on other biomarkers, and safety and tolerability.

“Supported by positive preclinical mechanistic and efficacy results in a [diet-induced obesity]-NASH model, we believe that PXL770 is uniquely positioned to treat the underlying root causes of fatty liver diseases as well as to specifically target each step of the pathophysiology of the disease, including liver steatosis, inflammation, ballooning and fibrosis,” Pascale Fouqueray, MD, PhD, executive vice president of translational medicine and early clinical development at Poxel, said in the release. “PXL770 may also provide benefits for comorbidities, including those related to cardiovascular disease.”

Poxel also plans to conduct a separate four-week pharmacokinetic-pharmacodynamic modeling study during the second quarter of 2019 to assess the effects of PXL770 on hepatic and metabolic parameters among patients with NAFLD.

“By targeting the master regulator of cellular energy, PXL770 has a unique and differentiated profile compared to other drug candidates in development for the treatment of NASH,” Thomas Kuhn, CEO of Poxel, said in the release. “The underlying pathophysiological mechanisms that contribute to the development and progression of NAFLD and NASH are highly complex and support the need for the development of novel therapies that act on different targets.”

Reference: www.poxelpharma.com