Sagimet Biosciences announced today that clinicians recently dosed the first patient with nonalcoholic steatohepatitis ( NASH ) in its FASCINATE-2 Phase 2b clinical trial.
| SAN MATEO, Calif., Aug. 16, 2021 /PRNewswire/ -- Sagimet Biosciences, a clinical-stage biotechnology company focused on developing a portfolio of internally-discovered, selective fatty acid synthase (FASN) inhibitors, announced today that clinicians recently dosed the first patient with nonalcoholic steatohepatitis (NASH) in its FASCINATE-2 Phase 2b clinical trial.
Eduardo Bruno Martins, MD, DPhil, Sagimet’s chief medical officer, said, “The initiation of the Phase 2 clinical trial marks an important milestone for the evaluation of our lead candidate TVB-2640. Building from the data seen in our FASCINATE-1 Phase 2a clinical trial, we believe TVB-2640 has the potential to make a meaningful difference for patients with NASH, the most aggressive form of nonalcoholic fatty liver disease (NAFLD), for which there are no FDA-approved therapies.” “After the robust and encouraging results from the Phase 2a study of TVB-2640, we are very excited to be enrolling individuals with NASH in the Phase 2b trial,” stated said Rohit Loomba, MD, MHSc, director, NAFLD Research Center, University of California San Diego, and coordinating investigator of the study. “The current standard of care for patients with NASH is suboptimal, and we anticipate the data from FASCINATE-2 will support advancing TVB-2640 into late-stage clinical trials.” Stephen A. Harrison, MD, medical director for Pinnacle Clinical Research, San Antonio, Texas, and visiting professor of Hepatology, University of Oxford, who is an investigator in this trial, noted, “The well-designed FASCINATE-2 study will generate important biomarker and imaging data to support the global research efforts to replace liver biopsy, the current gold-standard, with non-invasive tests that may be useful to diagnose and follow patients in both routine care and clinical trials.” About the FASCINATE-2 Clinical Trial Primary efficacy endpoints in FASCINATE-2 are:
The U.S. Food and Drug Administration (FDA) accepts these two endpoints for Phase 2b studies in NASH. Liver biopsy data will also be evaluated to assess NASH resolution without worsening of fibrosis and/or improvement in fibrosis without worsening of NASH, both of which are endpoints accepted by the FDA for accelerated approval following Phase 3 studies. The study will also measure liver fat, assessed by MRI-PDFF, and other serum biomarkers of inflammation, fibrosis, and liver injury in a portion of patients at 26 weeks of treatment in an interim analysis. Sagimet anticipates sharing interim results in the second half of 2022 and top-line liver biopsy results in 2023. About TVB-2640 About Sagimet
SOURCE Sagimet Biosciences |
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