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Poxel NASH candidate moves into phase 1b

Poxel SA announced the initiation of a phase 1b trial designed to investigate PXL065 for the treatment of nonalcoholic steatohepatitis in patients without cirrhosis, according to a press release.

PXL065 is a deuterium-stabilized R-stereoisomer of Actos (pioglitazone, Mylan Pharmaceuticals) that targets mitochondrial pyruvate carrier inhibition. Pioglitazone previously has demonstrated resolution of NASH without worsening of fibrosis in a phase 4 trial and is recommended in the AASLD practice guidelines for NASH.

“Our in-depth understanding of the cellular energy regulation pathways related to metabolic diseases, such as NASH, has helped to facilitate the rapid advancement of a diverse pipeline with two promising clinical programs for this chronic metabolic disease,” Thomas Kuhn, CEO of Poxel, said in the release. “Based on preclinical and phase 1 results to-date, we believe PXL065 has the potential to exhibit an improved therapeutic profile compared to pioglitazone for noncirrhotic NASH patients.”

Investigators of the randomized control phase 1b trial will enroll approximately 30 healthy participants who will receive 7.5 mg, 15 mg and then 30 mg of PXL065 during a period of 7 days and compare results with 45 mg of pioglitazone.

Poxel expects topline results in the fourth quarter of 2019.

Reference: www.poxelpharma.com