Poxel announces favorable safety, tolerability of NASH therapeutic

Poxel SA announced favorable results from its phase 1a two-part study of PXL065 compared with Actos for the treatment of nonalcoholic steatohepatitis, according to a press release.

PXL065 showed safety and tolerability with no serious adverse events and stabilization of R-pioglitazone with deuterium in all tested doses.

“We are pleased with the outcome of the PXL065 phase 1a study which supports the preclinical studies,” Thomas Kuhn, CEO of Poxel, said in the release. “We are planning to initiate the phase 1b multiple ascending dose trial in healthy subjects during the second quarter of 2019 with completion expected in the third quarter.”

The phase 1b study will be a randomized control trial that compares safety and tolerability of 15 mg of PXL065 with 45 mg of Actos (pioglitazone, Takeda) after 7 days of dosing.

“As a hepatologist, I participated in early phase 2 clinical trials with pioglitazone in biopsy-proven NASH patients,” Stephen A. Harrison, MD, Visiting Professor of Hepatology, Radcliffe Department of Medicine, University of Oxford in the United Kingdom, said in the release. “Although pioglitazone has achieved the most compelling treatment effects to date for resolution of NASH without worsening of fibrosis, it is only prescribed by a small percentage of physicians, around 14%, for biopsy-proven NASH patients. The primary reason for this is pioglitazone’s side effect of weight gain. I am excited about the potential for an improved therapeutic profile for PXL065 for the treatment of NASH, particularly the opportunity for reduced weight gain.”

Reference: www.poxelpharma.com