Sagimet Biosciences to Discuss Phase 2b FASCINATE-2 Data on ITT and F3 Patients

Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company, has announced a conference call and webcast scheduled for Thursday, June 13, 2024, at 9:30 AM PT / 12:30 PM ET. The event will focus on recent positive data from the Phase 2b FASCINATE-2 clinical trial of their lead drug candidate, denifanstat, in treating metabolic dysfunction-associated steatohepatitis (MASH). The call will be led by Dr. Rohit Loomba, a leading expert in gastroenterology and hepatology from the University of California San Diego.

Dr. Loomba, the Principal Investigator of the FASCINATE-2 study, will discuss the trial's promising results, which he recently presented at the European Association for the Study of the Liver (EASL) Congress held in Milan, Italy. Denifanstat, an oral, once-daily pill and selective fatty acid synthase (FASN) inhibitor, has shown efficacy in targeting dysfunctional metabolic and fibrotic pathways in MASH patients. Participants in the event will also have the opportunity to engage in a chat-based Q&A session with Dr. Loomba.

The FASCINATE-2 trial was a 52-week, randomized, double-blind, placebo-controlled study involving 168 biopsy-confirmed MASH patients with moderate-to-severe fibrosis (stage F2 or F3). Participants were randomly assigned in a 2:1 ratio to receive either 50 mg of denifanstat or a placebo, taken orally once daily. The primary endpoints of the trial were assessed through liver biopsies evaluated by a central pathologist and AI-based digital pathology.

Sagimet Biosciences is dedicated to developing innovative FASN inhibitors intended to address diseases linked to the overproduction of the fatty acid palmitate. Their lead candidate, denifanstat, has demonstrated positive outcomes in MASH patients through the FASCINATE-2 trial, which marks a significant milestone for the company.

Dr. Loomba, who serves as a scientific advisor for Sagimet, brings extensive expertise to the table. He is a board-certified gastroenterologist and transplant hepatologist with a focus on chronic liver diseases, including MASLD, nonalcoholic steatohepatitis, chronic hepatitis, cirrhosis, and hemochromatosis. As a professor at UC San Diego School of Medicine, he educates students, residents, and fellows in the field of gastroenterology.

Dr. Loomba is also the founding director of the UCSD MASLD Research Center, where a multidisciplinary team conducts cutting-edge research on MASLD. His work includes the development of non-invasive biomarkers, genetic studies, epidemiology, clinical trial design, and advanced imaging techniques. His research has led to several innovative applications, such as the establishment of MRI-PDFF as a non-invasive biomarker for early-phase MASH trials, now widely adopted in clinical trials globally.

With over 500 peer-reviewed publications, Dr. Loomba is a recognized leader in his field. He holds several patents related to non-invasive biomarkers for MASH and fibrosis. His research is funded by prestigious institutions, including the National Institutes of Health (NIH), where he serves as a Principal Investigator on multiple grants.

Sagimet's work on denifanstat represents a crucial advancement in the treatment of MASH, a condition affecting over 115 million people worldwide. The recent name change from non-alcoholic fatty liver disease (NAFLD) to metabolic dysfunction-associated steatotic liver disease (MASLD), and from nonalcoholic steatohepatitis (NASH) to MASH, aims to provide a more accurate and non-stigmatizing diagnosis.

The conference call and webcast are expected to provide valuable insights into Sagimet's ongoing clinical development and the future potential of denifanstat in treating MASH. As the event approaches, interested parties are encouraged to join the discussion and learn more about the promising advancements in this critical area of liver disease research.