Denifanstat Phase 2b FASCINATE-2 clinical trial 52-week data was presented in June at the European Association for the Study of the Liver (EASL) Congress
Preparations are ongoing to initiate a Phase 3 clinical development program for denifanstat in patients with metabolic dysfunction-associated steatohepatitis (MASH) in the second half of 2024
Two biotechnology industry leaders, Anne Phillips and Jennifer Jarrett, joined the Board of Directors effective August 1, 2024
Anticipated cash runway through 2025 with cash, cash equivalents and marketable securities totaling $188.5 million as of June 30, 2024
SAN MATEO, Calif., Aug. 14, 2024 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic pathways, today reported financial results for the second quarter ended June 30, 2024, and provided recent corporate updates.
“In June, we presented the full Phase 2b FASCINATE-2 clinical trial 52-week biopsy results at EASL showing denifanstat’s statistically significant fibrosis reduction in advanced F2 and F3 patients and a statistically significant delay in progression to cirrhosis,” said David Happel, Chief Executive Officer of Sagimet. “We believe these encouraging data, which demonstrate denifanstat’s mechanism of action as the only fat synthesis inhibitor that directly targets the three key drivers of MASH -- fat accumulation, inflammation, and fibrosis -- differentiate denifanstat from other therapeutics in the field. We plan to initiate the Phase 3 program for denifanstat in MASH in the second half of 2024 and intend to share the Phase 3 pivotal trial design later in the year. We look forward to progressing the development of denifanstat for patients living with MASH, a condition which has grown to epidemic levels worldwide.”
Recent Corporate Highlights
- On June 6, 2024, Sagimet presented the full 52-week data from the ITT and F3 patient population in the Phase 2b FASCINATE-2 clinical trial of denifanstat at EASL. Key outcomes data included:
- A statistically significant improvement in liver fibrosis by ≥1-stage without worsening of MASH at 52-weeks in ITT population and in patients with baseline stage 3 fibrosis.
- ITT (denifanstat 30% vs. placebo 14%, p=0.0199), and
- F3 mITT (denifanstat 49% vs. placebo 13%, p=0.0032)
- A statistically significant improvement in liver fibrosis by ≥2-stage without worsening of MASH at 52-weeks in mITT population and in patients with baseline stage 3 fibrosis.
- mITT (denifanstat 20% vs. placebo 2%, p=0.0065), and
- F3 mITT (denifanstat 34% vs. placebo 4%, p=0.0065)
- A statistically significant difference in progression to cirrhosis in F4 mITT population (denifanstat 5% vs. placebo 11%, p=0.0386).
- A statistically significant difference in fibrosis improvement by ≥ 1 stage with no worsening of MASH for patients on a stable background dose of a GLP-1RA (denifanstat 42% vs. placebo 0%, p=0.034) in mITT population.
- A statistically significant increase in beneficial polyunsaturated triglycerides at the end of 52 weeks of treatment (+42% denifanstat vs. -4% placebo, p
- A statistically significant improvement in liver fibrosis by ≥1-stage without worsening of MASH at 52-weeks in ITT population and in patients with baseline stage 3 fibrosis.