Sagimet Biosciences details 56.7% acne response at 52 weeks
The China extension followed 240 patients, with long-term safety as its primary aim, while Sagimet prepares a U.S. Phase 3 trial.
Adrian Kessler
A 56.7 per cent acne response gave Sagimet Biosciences Inc. NASDAQSGMT detailed long-term efficacy figures as its China partner disclosed full extension data Wednesday; shares had closed at US$9.33 on Nasdaq at 4 p.m. New York time Sept. 29. The 240-patient study primarily assessed safety, while its efficacy findings will inform Sagimet's planned U.S. trial.
The Sept. 30 release reported results from the ASC40-304 open-label extension in people with moderate to severe acne. Participants came from an earlier randomized study, but each received denifanstat during the extension, so its efficacy figures have no concurrent placebo comparison.
Sagimet is a Foster City, California, clinical-stage developer of medicines that inhibit fatty acid synthase for skin and metabolic diseases.
Sagimet reported US$257.6 million in cash, cash equivalents and marketable securities at June 30 and said that sum should fund current operations through 2028, including its planned U.S. Phase 3 readout. Patient screening is expected to begin in October.
Skin Clearance Rose in Both Extension Groups
The original China Phase 3 study randomized 480 patients to denifanstat or placebo for 12 weeks. Of those who entered the extension, 116 had already received denifanstat and 124 had received placebo; all received the drug during the subsequent 40-week open-label period.
At the end of the extension, 57.8 per cent of those treated with denifanstat from the start met the Investigator's Global Assessment response threshold. The corresponding figure for patients who switched from placebo was 55.6 per cent, giving an overall response of 56.7 per cent. That threshold meant a drop of at least two points and a final rating of clear or almost clear.
Across both groups, total lesion counts fell by a mean 71.8 per cent from the original trial baseline, while inflammatory lesions fell 76.9 per cent. Those are secondary efficacy measures: the extension's primary endpoints concerned safety. Since every participant received denifanstat during the extension, its 40-week results do not measure a treatment difference against a concurrent placebo group.
Sagimet said there were no adverse event-related permanent discontinuations and no drug-related serious adverse events among patients treated with denifanstat. Treatment-related dry skin occurred in 7.1 per cent, and dry eye in 5.9 per cent.
"Together, these results provide meaningful long-term experience with the 50 mg denifanstat dose we are taking forward in AURORA," Sagimet chief medical officer Andreas Grauer said in the release.
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U.S. Trial Will Test Benefit Against Placebo
Sagimet holds development rights outside China, while its license partner Ascletis BioScience develops denifanstat there as ASC40. The Chinese extension supplies longer exposure data for Sagimet, but the company's own U.S. AURORA study must establish whether the drug beats placebo on prespecified acne measures.
Sagimet's Aug. 25 trial plan calls for about 800 U.S. patients, including roughly 450 adolescents, with denifanstat and placebo assigned in a two-to-one ratio. Its three co-primary measures at week 12 include a global assessment response and changes in inflammatory and non-inflammatory lesion counts. Patients who finish that blinded phase can enter a 40-week safety extension; Sagimet said it anticipates an FDA application after the initial phase is complete.
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Shares of acne peer Sol-Gel Technologies, Ltd. NASDAQSLGL closed at US$72.25 on Nasdaq at 4 p.m. New York time on Sept. 29. Sol-Gel developed Twyneo, a topical acne cream that received FDA approval in July 2021, according to its approval release. Sagimet's candidate is an oral medicine.
Sagimet plans a webcast at 1 p.m. New York time on Sept. 30 to discuss the long-term results and AURORA. Patient screening is expected to begin in October, when the company will test whether its U.S. program starts on schedule.
