SAN MATEO, Calif. - Sagimet Biosciences Inc. (NASDAQ:SGMT) has reported positive results from its Phase 2b FASCINATE-2 clinical trial, evaluating the efficacy of denifanstat in treating metabolic-dysfunction associated steatohepatitis (MASH), a severe liver disease. The trial's findings, which were published in The Lancet Gastroenterology & Hepatology, indicate that denifanstat led to significant improvements in disease activity, MASH resolution, and fibrosis among patients.
The FASCINATE-2 trial involved 168 MASH patients with stage 2 or stage 3 fibrosis, who were administered a 50 mg daily oral dose of denifanstat or a placebo. After 52 weeks, denifanstat-treated patients showed a MASH resolution without worsening of fibrosis in 36% of cases versus 13% with placebo, and a ≥2-point reduction in NAS without worsening of fibrosis in 52% of cases versus 20% with placebo. These results were statistically significant and met the primary endpoints of the trial.
The study, led by Rohit Loomba, M.D., M.H.Sc., from the University of California San Diego, highlighted denifanstat's differentiated mechanism of action, which inhibits fatty acid synthase (FASN) activity in various cell types contributing to liver injury. The treatment also demonstrated significant results on multiple secondary endpoints, including fibrosis improvement by ≥1 stage without worsening of steatohepatitis in 41% of denifanstat-treated patients versus 18% with placebo.
Non-invasive biomarkers of liver health also improved with denifanstat treatment. Notably, there were no Grade ≥3 treatment-related adverse events or drug-induced liver injury signals reported in the study.
Dave Happel, CEO of Sagimet, expressed confidence in the potential of denifanstat to improve patient outcomes, especially as the disease progresses. Based on these encouraging results, Sagimet plans to advance denifanstat into Phase 3 development in 2024, following the FDA's Breakthrough Therapy designation granted to denifanstat for MASH treatment with moderate to advanced liver fibrosis.
MASH affects over 115 million people globally, with only one treatment recently approved in the United States and none in Europe. Sagimet's development of denifanstat aims to address this urgent need for effective treatments.
The information in this article is based on a press release statement from Sagimet Biosciences Inc.
In other recent news, Sagimet Biosciences has been making significant strides in the development of its drug, denifanstat. Leerink Partners maintained their Outperform rating for the company, highlighting the drug's potential in treating non-alcoholic steatohepatitis (NASH). Notably, Sagimet's Phase 2b FASCINATE-2 trial showed positive results, particularly in patients with stage F3 fibrosis.
Sagimet Biosciences also received a Buy rating from TD Cowen, which cited the company's strong financial position and promising clinical trial data. However, Goldman Sachs downgraded the company from "Buy" to "Neutral," even as H.C. Wainwright initiated coverage with a Buy rating.
The company has initiated a $75 million equity offering in partnership with Cantor Fitzgerald & Co., providing a flexible financing option for its operations and growth initiatives. Additionally, Sagimet Biosciences expanded its board of directors, appointing Jennifer Jarrett and Dr. Anne Phillips as new members.
These are recent developments in the company's ongoing efforts to advance its pharmaceutical programs and establish itself as a key player in the NASH treatment landscape.
InvestingPro Insights
As Sagimet Biosciences Inc. (NASDAQ:SGMT) advances its promising MASH treatment, denifanstat, towards Phase 3 development, investors may find additional context from InvestingPro's real-time data and insights valuable.
According to InvestingPro data, Sagimet's market capitalization stands at $132.12 million, reflecting the market's current valuation of the company's potential. This relatively modest market cap suggests there could be significant upside if denifanstat's development continues to progress positively.
InvestingPro Tips highlight that Sagimet "holds more cash than debt on its balance sheet" and "liquid assets exceed short term obligations." These financial strengths could be crucial as the company prepares for the costly Phase 3 trials, potentially reducing the need for dilutive financing.
While the company is not currently profitable, with a negative P/E ratio of -4.52 for the last twelve months as of Q2 2023, analysts anticipate sales growth in the current year. This expectation aligns with the positive clinical results and the company's progression towards commercialization.
It's worth noting that Sagimet has shown a strong return over the last three months, with InvestingPro data indicating a 26.61% price total return. This performance may reflect growing investor confidence in the company's clinical progress.
For those interested in a deeper analysis, InvestingPro offers 8 additional tips for Sagimet Biosciences, providing a more comprehensive view of the company's financial health and market position.
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