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Ascletis receives investigational new drug approval for NASH candidate

Ascletis Pharma together with Sagimet Biosciences received investigational new drug approval from the National Medical Products Administration for ASC40, its therapeutic candidate for the treatment of nonalcoholic steatohepatitis, according to a press release.

“We are excited by IND approval of ASC40 (TVB-2640) from NMPA for the global multicenter trial,” Jinzi J. Wu, PhD, founder, chairman and CEO of Ascletis, said in the release. “Sagimet and Ascletis teams are working hand-in-hand to accelerate the advancement of ASC40 (TVB-2640) on a global scale.”

ASC40 is an orally bioavailable inhibitor of fatty acid synthase and is currently under investigation in a global phase 2 trial for patients with NASH.

Investigators enrolled and randomly assigned 90 patients with NASH and evidence of stage 1 to stage 3 fibrosis in the United States and approximately 30 similarly diagnosed patients in China to receive either ASC40 or placebo. The primary endpoint will be the impact on liver fat reduction compared with baseline after 12 weeks of daily dosing. Investigators will also evaluate the therapeutic’s impact on levels of plasma triglycerides, liver enzymes, inflammatory and fibrotic biomarkers.

Reference: www.ascletis.com