Sagimet Stock Jumps on Positive Acne Drug Safety Data

Stock Rises on Strong Phase 3 Results

Sagimet Biosciences Inc. (NASDAQ:SGMT) saw its stock increase by 4.6% following the announcement of positive topline results from a long-term Phase 3 safety study. The trial for the acne drug denifanstat was conducted by Ascletis Pharma, Sagimet's partner in China.

Trial Overview and Key Findings

The 40-week open-label Phase 3 trial evaluated the safety of denifanstat, marketed as ASC40 in China, in patients with moderate to severe acne. The study demonstrated that the drug was generally well-tolerated. Treatment-emergent adverse events occurring in more than 5% of patients were limited to dry eye syndrome (5.5%) and dry skin (5.2%). All reported drug-related adverse events were classified as mild or moderate, with no patients discontinuing the trial due to these events.

Market Impact and Drug Potential

This positive long-term safety data builds on a previous announcement in June, where denifanstat met all primary and secondary endpoints in a placebo-controlled Phase 3 trial. The results strengthen confidence in the clinical potential of FASN inhibition as a novel treatment mechanism for acne. While Ascletis is developing the drug for acne in China, Sagimet is developing it for MASH (Metabolic dysfunction-Associated SteatoHepatitis) in other global markets, and this safety profile is beneficial for both indications.

Future Outlook

The successful completion of the long-term safety study provides crucial data supporting the drug's profile. This development is a significant step for both Ascletis's acne program in China and Sagimet's global MASH program, potentially paving the way for regulatory submissions.

FAQ

Q: Why did Sagimet (SGMT) stock increase?
A: The stock rose 4.6% after its Chinese partner, Ascletis Pharma, released positive long-term safety data from a Phase 3 trial for the acne drug denifanstat.

Q: What were the main findings of the safety trial?
A: The trial showed denifanstat was well-tolerated over 40 weeks, with only mild to moderate adverse events like dry eye and dry skin reported and no permanent discontinuations.

Q: What is denifanstat?
A: It is an oral fatty acid synthase (FASN) inhibitor being developed to treat acne in China and Metabolic dysfunction-Associated SteatoHepatitis (MASH) in the rest of the world.

Source: Investing.com