Shares of Sagimet Biosciences (NASDAQ: SGMT) skyrocketed 154% in the afternoon trading Monday following the release of positive topline results from Phase 2b FASCINATE-2 clinical trial of Denifanstat in Biopsy-Confirmed F2/F3 NASH.
Sagimet Biosciences (NASDAQ: SGMT) has shared some great news about its latest research in the battle against liver disease. The company announced positive findings from its FASCINATE-2 Phase 2b clinical trial of a denifanstat drug. This trial focused on patients with a liver condition called non-alcoholic steatohepatitis (NASH), specifically those with stage 2 or stage 3 fibrosis (F2/F3) at week 52.
Denifanstat, an oral medication designed to inhibit FASN (Fatty Acid Synthase), has shown significant progress compared to a placebo. The trial achieved two crucial goals: first, an improvement in NASH without making fibrosis worse, including a ≥2-point reduction in NAS (NAFLD Activity Score); second, a ≥2-point reduction in NAS without worsening fibrosis.
In addition, patients treated with denifanstat showed a significant improvement in fibrosis by at least one stage without making NASH worse. Moreover, a higher percentage of denifanstat-treated patients responded positively to MRI-derived proton density fat fraction (MRI-PDFF), with a ≥30% reduction compared to those on the placebo.
Dave Happel, CEO of Sagimet Biosciences (NASDAQ: SGMT), said,
“Denifanstat is designed to reduce the three main drivers of NASH, including fat accumulation, inflammation, and fibrosis, both independently and in parallel. The week 52 biopsy results showed that denifanstat achieved statistical superiority over placebo in reduction of fibrosis, via two independent processes of traditional histopathology and AI digital pathology.”
He added,
“Sagimet is committed to creating novel approaches to target dysfunctional metabolic pathways, and we believe these positive results represent a major advancement in that endeavor. Our next step will be holding an End-of-Phase 2 meeting with the FDA and starting our Phase 3 program for development of denifanstat in NASH with related fibrosis, which we anticipate to begin in the second half of 2024.”
Rohit Loomba, M.D., M.H.Sc., Professor of Medicine, Chief, Division of Gastroenterology and Hepatology, and Director, MASLD Research Center, University of California San Diego, who serves as a scientific advisor for Sagimet on its ongoing development of denifanstat commented,
“The over-activity of fatty acid synthase and increased de-novo lipogenesis or DNL plays a critical role in the development of NASH and its progression to cirrhosis.”
He added,
“Denifanstat is the only FASN inhibitor currently in clinical development for the treatment of NASH with related fibrosis. These data show that blocking fatty acid synthesis in the liver and DNL is a critical approach for NASH resolution and improvements in fibrosis. These results support denifanstat’s mechanism of action and the impact of addressing these multiple pathways simultaneously. Moreover, the safety profile supports the further development of denifanstat in NASH patients.”
SGMT stock was up 154% in the afternoon trading Monday, with a trading volume of 29,940,350 (29.94 million) shares. This figure significantly surpasses the company’s daily average trading volume of 152.93K shares.
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