Sagimet's Partner Achieves Positive Results With Oral Acne Drug In Phase 3 Trial In China, Stock Jumps

Sagimet Biosciences Inc. SGMT said on Wednesday that denifanstat met all primary and secondary endpoints in a Phase 3 trial for moderate to severe acne vulgaris.

The trial was conducted by Sagimet’s license partner, Ascletis Bioscience Co. Ltd., in China.

Denifanstat is a once-daily oral small-molecule fatty acid synthase (FASN) inhibitor being developed by Ascletis as ASC40 for acne in China and by Sagimet for metabolic dysfunction-associated steatohepatitis (MASH) in the rest of the world.

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Additionally, Sagimet recently initiated a Phase 1 first-in-human trial with a second FASN inhibitor, TVB-3567, that is planned to be developed for acne in the U.S.

The trial randomized 480 patients in China to receive either denifanstat once daily or a placebo for 12 weeks.

For the primary endpoint of treatment success, defined as an Investigator’s Global Assessment score of 0 (clear) or 1 (almost clear) with at least a 2-point decrease from baseline at week 12, the denifanstat group demonstrated a statistically significant 33.2% rate over the placebo group’s 14.6%.

Additional goals further corroborated denifanstat’s efficacy versus placebo, including:

• Reduction in total lesion count (57.4% vs 35.4%).
• Reduction in inflammatory lesion count (63.5% vs 43.2%).
• Reduction in non-inflammatory lesion count (51.9% vs. 28.9%).

Ascletis reported that denifanstat was generally well-tolerated. Following 12 weeks of once-daily oral administration at 50 mg, treatment-emergent adverse events (TEAE) incidence rates were comparable between denifanstat and placebo.

All denifanstat-related adverse events (AEs) were mild or moderate. There were no denifanstat-related grade 3 or 4 AEs and no denifanstat-related serious AEs. No deaths were reported.

These Phase 3 results confirm that FASN inhibition represents a potential therapeutic approach within acne. Ascletis has indicated that it plans to submit denifanstat for approval to the China National Medical Products Administration.

Building on Ascletis’ Phase 3 results, Sagimet has recently initiated a Phase 1 first-in-human clinical trial with a second oral FASN inhibitor drug candidate, TVB-3567, that is planned to be developed for acne in the U.S.

In other notable pharmaceutical industry news, GSK plc GSK agreed to acquire Boston Pharmaceuticals’ lead asset, efimosfermin alfa, a phase 3-ready, investigational specialty medicine for treating and preventing the progression of steatotic liver disease in May.

Under the agreement, GSK will pay up to $2 billion in total cash consideration, including $1.2 billion upfront, with the potential for additional success-based milestone payments totaling $800 million.

This highlights ongoing investment in the liver disease space, an area where Sagimet is also active with its MASH program.

Price Action: SGMT stock is trading higher by 31.7% to $4.78 premarket at last check Wednesday.

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