3-V Biosciences doses first patient with fatty acid inhibitor for NASH

3-V Biosciences dosed its first patient in a phase 2 clinical trial of a fatty acid inhibitor candidate from Ascletis for the treatment of nonalcoholic steatohepatitis, according to a press release.

“Lipid synthesis is an important driver of NASH,” Rohit Loomba, MD, from the University of California San Diego, and coordinating investigator of the phase 2 study, said in the release. “The imaging techniques in this study will give us a very clear understanding of the impact this drug has on liver fat, a key driver of this disease.”

TVB-2640 is an orally bioavailable inhibitor for the fatty acid synthase that showed positive results in a phase 1 study of patients with metabolic syndrome.

The upcoming randomized control study is designed to evaluate the impact of TVB-2640 in approximately 90 patients with NASH in the U.S. and 25 to 30 patients with NASH in China. Inclusion criteria consists of at least 8% liver fat at baseline and evidence of fibrosis stage 1 to stage 3.

The primary endpoint will be impact on liver fat reduction from baseline after 12 weeks of daily dosing.

“The initiation of our phase 2 clinical trial is a very important advance for TVB-2640 and for 3-V Biosciences,” William McCulloch, FRCP, FFPM, chief medical officer of 3-V Biosciences, said in the release. “We are very encouraged by the data from the Phase 1 studies and this next step is critical in determining the impact TVB-2640 may have in the treatment of NASH patients.”

Reference: www.3vbio.com