Sagimet Biosciences shares soar on positive acne treatment trial results

Investing.com -- Shares of Sagimet Biosciences Inc. (NASDAQ:SGMT) surged 20% following the announcement of positive Phase 3 clinical trial results for its acne treatment, denifanstat. The trial, conducted by Sagimet’s licensing partner Ascletis Bioscience Co. Ltd. in China, met all primary and secondary endpoints, bolstering investor confidence in the company’s prospects.

Sagimet, a clinical-stage biopharmaceutical company, revealed that denifanstat, a once-daily oral fatty acid synthase (FASN) inhibitor, demonstrated significant efficacy in treating moderate to severe acne vulgaris. The 480-patient study showed that denifanstat outperformed placebo in reducing total lesion count and inflammatory lesion count, with treatment success rates also surpassing those of the placebo group.

The positive outcome of the trial supports the therapeutic potential of FASN inhibition in addressing acne vulgaris, a condition affecting over 640 million people globally. Sagimet’s CEO, David Happel, expressed optimism about the results, highlighting the novel approach of FASN inhibition in treating a widespread and persistent skin condition.

Dr. Neal Bhatia, a leading dermatologist, emphasized the importance of new treatments for acne, considering the limited advances in the field over the past four decades. Bhatia pointed out that denifanstat addresses key pathways in acne development through a unique mechanism of action, offering hope for improved patient outcomes.

Safety data from the trial indicated that denifanstat was generally well-tolerated, with no serious adverse events linked to the treatment. Mild side effects such as dry skin and dry eye were reported but were not significantly higher than those observed in the placebo group.

In light of the promising results, Ascletis is planning to seek approval for denifanstat from the China National Medical (TASE:BLWV) Products Administration. Moreover, Sagimet has initiated a Phase 1 clinical trial for another FASN inhibitor, TVB-3567, to be developed for the acne market in the U.S.

Leerink Partners analyst Thomas Smith commented on the trial’s success, reiterating an Outperform rating and a $26.00 price target for Sagimet. Smith stated, "Overall, we believe these topline Phase 3 acne results from Ascletis in China meaningfully add to deni’s safety dataset, and suggest an attractive clinical profile for FASN inhibition in acne and NASH." He views the results as a positive development for Sagimet’s ongoing efforts in NASH and acne treatment, potentially positioning the company as a key player in these therapeutic areas.

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