Sagimet To Present Positive Full 52-Week Results from License Partner Ascletis' Phase 3 Open-Label Extension Clinical Trial of Denifanstat in Acne and Mechanistic Data at the 2026 Fall Clinical Dermatology Conference
The extension reported continued efficacy through 52 weeks as Sagimet’s U.S. Phase 3 AURORA trial begins patient screening.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Sagimet Biosciences (SGMT) announced 52-week acne results from license partner Ascletis’ Phase 3 denifanstat extension trial, including 57% IGA success. IGA is the Investigator’s Global Assessment of acne severity. Total lesions fell 72% and inflammatory lesions fell 77% from baseline. Denifanstat was generally well-tolerated, with continued improvement across efficacy endpoints.
The China trial was an open-label extension of a 12-week placebo-controlled study; safety was its primary endpoint and efficacy was secondary. Clinical and mechanistic data are being presented at the October 8–11, 2026 Fall Clinical Dermatology Conference in Las Vegas. Ascletis’ application for approval in China was accepted in December 2025. Sagimet’s U.S. Phase 3 AURORA trial is screening patients, with sites activated and institutional review board approvals in place.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- Moderate pointIGA success reached 57% through 52 weeks in Ascletis’ denifanstat acne extension trial.
- Moderate point12-week results showed significant IGA and lesion-count improvements versus placebo, with significant improvements as early as four weeks.
- Moderate pointChina approval application for Ascletis’ denifanstat was accepted by the NMPA in December 2025.
- Minor pointTotal lesion count fell 72% from baseline through 52 weeks.
- Minor pointInflammatory lesion count fell 77% from baseline through 52 weeks.
3 minor points
- Minor pointDenifanstat was generally well-tolerated in the extension evaluating long-term safety.
- Minor pointAURORA U.S. Phase 3 is screening patients, with sites activated and institutional review board approvals in place.
- Minor pointFASN inhibition reduced sebum lipids in laboratory human sebocytes and clinical-trial participants.
Negative
- Minor point52-week efficacy findings came from an open-label extension, with efficacy assessed as secondary endpoints.
Key Figures
- IGA success
- 57%
- Through 52 weeks
- Total lesion reduction
- 72%
- Through 52 weeks
- Inflammatory lesion reduction
- 77%
- Through 52 weeks
- Patients in extension trial
- 240 patients
- Phase 3 open-label extension
Previous Clinical trial Reports
-
Ascletis reported 56.7% treatment success and lesion reductions in the same 52-week China extension.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
open-label extension medical
fatty acid synthase medical
de novo lipogenesis medical
nda regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Denifanstat showed continued improvement and sustained efficacy across all efficacy endpoints through 52 weeks, including
57% IGA success,72% reduction in total lesions, and77% reduction in inflammatory lesions, and was generally well-tolerated - Clinical findings and preclinical mechanistic evidence support FASN inhibition as a novel oral therapeutic approach targeting key aspects of acne pathogenesis
- AURORA U.S. Phase 3 trial screening patients, with sites activated and IRB approvals in place
FOSTER CITY, Calif., Oct. 09, 2026 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced that the positive 52-week clinical results from the Phase 3 ASC40-304 open-label extension of denifanstat in patients with moderate to severe acne vulgaris, conducted by license partner Ascletis BioScience Co. Ltd. (Ascletis) in China, along with mechanistic data, will be presented at the 2026 Fall Clinical Dermatology Conference taking place October 8-11, in Las Vegas, Nevada. Denifanstat is a once-daily oral small molecule fatty acid synthase (FASN) inhibitor being developed by Ascletis as ASC40 in China where it holds an exclusive license to denifanstat, and by Sagimet in the rest of the world.
The Phase 3 OLE clinical trial, ASC40-304, evaluated the long-term safety of denifanstat in patients with moderate to severe acne vulgaris who were previously enrolled in the 12-week randomized, double-blind, placebo-controlled Phase 3 ASC40-303 clinical trial. Both trials were conducted in China by Ascletis. 240 patients rolled over into the OLE trial, for a total trial duration of up to 52 weeks; 116 of those patients had received denifanstat in the original ASC40-303 trial, and 124 patients had received placebo. Primary endpoints of the OLE evaluated safety and secondary endpoints evaluated efficacy, including Investigator’s Global Assessment (IGA) success and reduction in total lesion count and inflammatory lesion count from baseline. Ascletis’ NDA submission for approval in China to the National Medical Products Association (NMPA) was accepted in December 2025.
2026 Fall Clinical Dermatology Conference Poster Presentation Details:
| Title: | Denifanstat, a fatty acid synthase inhibitor, achieved significant clinical improvement in moderate-to-severe acne vulgaris: a review of mechanistic and clinical data |
| Presenting author: | Julie Harper, MD, Founding Director and past President of the American Acne and Rosacea Society, Dermatology and Skin Care Center of Birmingham in Birmingham, Alabama |
| Date: | October 8 - 11, 2026 |
| Location: | The Wynn Hotel, Las Vegas, Nevada |
| Key Presentation Highlights:
| |
“The data being presented at the Fall Clinical Dermatology Conference highlight the potential and novel role of FASN inhibition to treat patients and families living with acne,” said David Happel, Chief Executive Officer of Sagimet. “Denifanstat has demonstrated significant and sustained improvements in moderate to severe acne through 52 weeks of treatment. With AURORA sites activated and patient screening beginning this month, we are excited to be advancing denifanstat into our U.S. Phase 3 program.”
About the Ascletis Phase 3 Clinical Trial and Open-Label Extension
ASC40-303 (NCT06192264) was a randomized, double-blind, placebo-controlled 12-week Phase 3 clinical trial of denifanstat in 480 patients with moderate to severe acne vulgaris, conducted in China by Ascletis. Patients were randomized 1:1 to denifanstat 50 mg or placebo once daily. Denifanstat met all primary and secondary endpoints and was generally well-tolerated.
ASC40-304 (NCT06248008) was a multi-center, open-label Phase 3 extension evaluating the long-term safety of denifanstat in patients with moderate to severe acne vulgaris who were previously enrolled in the double-blind, randomized, placebo-controlled 12-week Phase 3 ASC40-303 trial. This open-label Phase 3 trial enrolled 240 subjects who received oral denifanstat 50 mg once daily for up to 40 weeks. Subjects who were originally randomized to denifanstat in ASC40-303 trial had a total of up to 52 weeks of denifanstat exposure. Primary endpoints evaluated safety, and secondary endpoints evaluated efficacy, including the number of patients with IGA success and the reduction in total lesion count and inflammatory lesion count from baseline for up to 52 weeks of denifanstat treatment. Denifanstat was generally well-tolerated. Subjects treated with denifanstat showed improvements in all efficacy endpoints (secondary endpoints of the trial) beyond those observed at 12 weeks.
About the AURORA Phase 3 Clinical Trial
The AURORA (NCT07863193) multi-center, randomized, double-blind, placebo-controlled Phase 3 clinical trial of denifanstat in moderate to severe acne is intended to enroll approximately 800 U.S. patients aged 12 years and older, of which 450 are expected to be adolescents aged 12 to 17 years. Patients will be randomized 2:1 to receive denifanstat 50 mg or placebo once daily for 12 weeks. The trial will have three co-primary endpoints that will be assessed at week 12: the proportion of patients achieving treatment success in a global assessment score, defined as at least a 2-point reduction from baseline with a score of 0 (clear) or 1 (almost clear); absolute change in inflammatory skin lesion counts from baseline; and absolute change in non-inflammatory skin lesion counts from baseline. A subset of approximately 530 patients completing the double-blind period will be eligible to enter a 40-week open-label extension evaluating the long-term safety of denifanstat.
About Denifanstat
Denifanstat is an oral, once-daily FASN inhibitor in development for the treatment of moderate to severe acne. In trials conducted by Sagimet’s license partner, Ascletis BioScience Co. Ltd. (Ascletis) in China, denifanstat met all primary and secondary endpoints in a 12 week randomized, double-blind Phase 3 clinical trial in moderate to severe acne vulgaris and was generally well-tolerated and showed improvements in all efficacy endpoints measured at 52 weeks (secondary endpoints of the trial) in an open-label extension clinical trial evaluating denifanstat’s long-term safety in patients with moderate to severe acne. Denifanstat is being developed by Ascletis as ASC40 for acne in China and by Sagimet in the rest of world.
About Acne
Acne is one of the most common skin conditions in the U.S., with approximately 50 million Americans affected annually and more than 5 million seeking medical treatment for acne each year. Acne affects around
About Sagimet Biosciences
Sagimet is a clinical-stage biopharmaceutical company developing novel FASN inhibitors designed to target dysfunctional metabolic and fibrotic pathways in conditions resulting from the overproduction of the fatty acid, palmitate. FASN is a regulator of lipid synthesis, a key pathway implicated in multiple diseases, such as acne, MASH and certain FASN-dependent tumor types. For additional information about Sagimet, please visit www.sagimet.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of, and made pursuant to the safe harbor provisions of, The Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding the expected timing of the presentation of data from ongoing clinical trials, Sagimet’s clinical development plans and related timelines and anticipated development milestones, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause Sagimet’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, these statements can be identified by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this press release are only predictions. Sagimet has based these forward-looking statements largely on its current expectations and projections about future events and financial trends that Sagimet believes may affect its business, financial condition and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Sagimet’s control, including, among others: the clinical development and therapeutic potential of denifanstat, TVB-3567 or any other drug candidates or combination therapies developed by Sagimet; Sagimet’s ability to advance drug candidates into and successfully complete clinical trials within anticipated timelines; Sagimet’s relationship with Ascletis, and the success of its development and registration efforts for denifanstat; the accuracy of Sagimet’s estimates regarding its capital requirements and Sagimet’s ability to maintain and successfully enforce adequate intellectual property protection. These and other risks and uncertainties are described more fully in the “Risk Factors” section of Sagimet’s most recent filings with the Securities and Exchange Commission and available at www.sec.gov. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in these forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, Sagimet operates in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that Sagimet may face. Except as required by applicable law, Sagimet does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
Investor Contact:
Joyce Allaire
LifeSci Advisors
JAllaire@LifeSciAdvisors.com
Media Contact:
Maggie Whitney
LifeSci Communications
mwhitney@lifescicomms.com
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What were the 52-week denifanstat acne results announced by Sagimet (SGMT)?
Denifanstat achieved 57% Investigator’s Global Assessment success, a 72% reduction in total lesions and a 77% reduction in inflammatory lesions from baseline through 52 weeks. The extension trial reported continued improvement across efficacy endpoints, and denifanstat was generally well-tolerated.
What is the status of Sagimet’s AURORA U.S. Phase 3 acne trial?
The AURORA U.S. Phase 3 trial is screening patients, with sites activated and institutional review board approvals in place. Sagimet said patient screening was beginning in October 2026.
Who participated in Ascletis’ denifanstat extension trial reported by Sagimet?
The extension enrolled 240 patients previously enrolled in the 12-week randomized, double-blind, placebo-controlled Phase 3 ASC40-303 trial. Of these, 116 had received denifanstat and 124 had received placebo. Both studies were conducted in China, and total trial duration was up to 52 weeks.
How are denifanstat development rights divided between Sagimet and Ascletis?
Ascletis holds an exclusive license in China, where it develops denifanstat as ASC40, while Sagimet develops denifanstat in the rest of the world.