Sagimet Biosciences to Host Virtual KOL Event, “A New Mechanism of Action in Treating Acne: Update on Positive Phase 3 Denifanstat Trial for the Treatment of Moderate to Severe Acne” on June 16, 2025

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Sagimet Biosciences (NASDAQ: SGMT) announced a virtual KOL event scheduled for June 16, 2025, featuring Dr. Neal Bhatia to discuss positive Phase 3 trial results of denifanstat for moderate to severe acne treatment. The study, conducted by license partner Ascletis in China, met all primary and secondary endpoints versus placebo with good tolerability. Denifanstat, a once-daily oral FASN inhibitor, represents a novel treatment approach for acne, which affects over 50 million Americans annually. The company will also discuss their Phase 1 trial of TVB-3567, their second oral FASN inhibitor candidate for acne treatment in the U.S. The event will include a Q&A session, with a replay available on Sagimet's website for 90 days.

SAN MATEO, Calif., June 09, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced it will host a virtual key opinion leader (KOL) event on Monday, June 16, 2025 at 2:00 PM ET. To register, click here.

The event will feature key opinion leader (KOL) Neal Bhatia, MD (Director of Clinical Dermatology at Therapeutics Clinical Research in San Diego), who will join company management to review positive efficacy and tolerability results from a Phase 3 clinical trial evaluating denifanstat for the treatment of moderate to severe acne vulgaris in China conducted by Sagimet’s license partner Ascletis.

Denifanstat is a once-daily oral small molecule fatty acid synthase (FASN) inhibitor. In the Phase 3 study, denifanstat met all primary and secondary endpoints versus placebo and was generally well tolerated. The robust Phase 3 results underline the potential of FASN inhibition as a novel mechanism of action to address acne, a condition that impacts more than 50 million people in the U.S. annually. Management will also discuss the Company’s recently initiated Phase 1 first in-human study with its second oral FASN inhibitor drug candidate, TVB-3567, which is planned to be developed for acne in the U.S.

A live question and answer session will follow the formal presentations. A replay of this event will be available in the Investors & Media section of Sagimet’s website at www.sagimet.com for 90 days following the live event.

About Dr. Neal Bhatia, MD 

Neal Bhatia, MD is a board-certified dermatologist practicing in San Diego, California. He serves as Director of Clinical Dermatology at Therapeutics Clinical Research and as chief medical editor for Practical Dermatology. He is the past vice president of the American Academy of Dermatology. He is widely published and has a background in immunology as well as interests in mechanisms of therapy, skin cancer, acne and medical dermatology.

About Sagimet Biosciences 

Sagimet is a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors that are designed to target dysfunctional metabolic and fibrotic pathways in diseases resulting from the overproduction of the fatty acid, palmitate. Sagimet’s lead drug candidate, denifanstat, is an oral, once-daily pill and selective FASN inhibitor in development for the treatment of metabolic dysfunction associated steatohepatitis (MASH). FASCINATE-2, a Phase 2b clinical trial of denifanstat in MASH with liver biopsy-based primary endpoints, was successfully completed with positive results. Denifanstat has been granted Breakthrough Therapy designation by the FDA for the treatment of non-cirrhotic MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), and end-of-Phase 2 interactions with the FDA have been successfully completed, supporting the advancement of denifanstat into further development. 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 US. For additional information about Sagimet, please visit www.sagimet.com.

About Acne

There are 5.1 million acne patients in the U.S. who are treated by dermatologists annually, and a total U.S. acne market of over 50 million people. ^1,2 There is no cure for acne; and due to its pathology, most patients require chronic management and multiple courses of treatment for flare control annually. Additionally, adherence to topical therapies is lower than with oral agents, with an estimated 30% to 40% of patients not adhering to their topical treatments. ³

1. Bickers DR, Lim HW, Margolis D, Weinstock MA, Goodman C, Faulkner E et al. The burden of skin diseases: 2004 a joint project of the American Academy of Dermatology Association and the Society for Investigative Dermatology. Journal of the American Academy of Dermatology 2006;55:490-500.
2. American Academy of Dermatology/Milliman. Burden of Skin Disease. 2017. www.aad.org/BSD.
3. Purvis CG, Balogh EA, Feldman SR. Clascoterone: How the Novel Androgen Receptor Inhibitor Fits Into the Acne Treatment Paradigm. Ann Pharmacother. 2021;55(10):1297-1299. doi:10.1177/1060028021992055.
   

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 anticipated development milestones, Sagimet’s cash and financial resources and expected cash runway. 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 or any other drug candidates Sagimet may develop; 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 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:
Michael Fitzhugh
LifeSci Advisors 
mfitzhugh@lifescicomms.com

FAQ

What are the key findings from Sagimet's Phase 3 denifanstat trial for acne treatment?

The Phase 3 trial met all primary and secondary endpoints versus placebo and demonstrated good tolerability for treating moderate to severe acne vulgaris in China.

When is Sagimet (SGMT) hosting their KOL event for denifanstat acne treatment results?

Sagimet is hosting the virtual KOL event on Monday, June 16, 2025, at 2:00 PM ET, featuring Dr. Neal Bhatia from Therapeutics Clinical Research.

What is denifanstat and how does it work for acne treatment?

Denifanstat is a once-daily oral small molecule fatty acid synthase (FASN) inhibitor, representing a novel mechanism of action for treating acne.

What is Sagimet's development pipeline for acne treatments?

Sagimet has denifanstat in Phase 3 and has recently initiated a Phase 1 first-in-human study with TVB-3567, their second oral FASN inhibitor drug candidate for acne treatment in the U.S.

How many people are affected by acne in the United States?

Acne impacts more than 50 million people in the United States annually.