On the Horizon: Innovations in the Acne Treatment Pipeline

The future of acne treatment could see innovative approaches, according to Hilary Baldwin, MD. As research pinpoints the role of inflammation in acne pathophysiology, there are increased opportunities for treatment modalities and mechanisms of action, she told Dermatology Times.

Sponge-Derived Therapy

One of the more unusual acne agents in development to leverage the anti-inflammatory approach is a compound derived from a freshwater sponge, explained Baldwin, medical director of the Acne Treatment and Research Center in Brooklyn, New York.

DMT 310 (Xyngari; Dermata) leverages Spongilla’s green spicules and distinct physical and biochemical effects as part of its unique mechanism of action. The spicules open comedones and create microchannels “to facilitate penetration of active ingredients,” Baldwin explained. It also promotes collagen production, and has been shown to have antimicrobial and anti-inflammatory properties, offering IL-17–targeted activity.¹

In Dermata Therapeutics, Inc’s phase 2b trial (NCT06090721), patients treated with the agent demonstrated greater reduction in inflammatory and noninflammatory lesions compared with those on placebo at week 12, as well as higher rates of Investigator’s Global Assessment (IGA).² Baldwin added that the phase 3 program has been completed, generating further interest. The trial included 550 participants 9 years and older with moderate to severe acne who received a once-weekly application for 12 weeks. Although full data have not been released, topline data from the Spongilla Treatment for Acne Research (STAR-1) program indicated it met all primary end points, positioning it to be “the first once-weekly topical product candidate to demonstrate clinical benefit in a phase 3 clinical trial for moderate to severe acne.”³

Sebum-Targeted Pathways

Another first-in-class agent and late-stage candidate generating interest is Ascletis Pharma Inc’s ASC40 (denifanstat), which acts as a farnesyltransferase inhibitor to reduce sebum production secondary to inhibition of lipogenesis. Baldwin explained that it also inhibits inflammation related to decreased cytokine secretion and Th17 differentiation.¹ Because excess sebum remains foundational in acne pathophysiology, Baldwin emphasized the importance of this approach in treating acne.

The phase 3 multicenter, double-blind, placebo-controlled study (NCT06192264) was conducted in China and included 480 patients with moderate to severe acne. In the double-blind portion, 240 patients received denifanstat 50 mg for 12 weeks, and results were compared with those of patients on placebo during that time to ascertain efficacy. During the open-label phase, the 240 patients continued receiving the dose for a total of 52 weeks to assess safety.^1,4

Baldwin said the results were recently released, “with really good results in terms of lesion count reduction and IGA improvement.” Specifically, the agent met all primary and key secondary efficacy end points, addressing IGA success and total lesion count reduction. It also demonstrated a good safety and tolerability profile, with only mild to moderate related adverse events and only 2 categories (dry eyes and dry skin) reaching an incidence of 5%.^1,4

Vaccines and Microbiomes

Baldwin is also excited about the potential of an acne vaccine. “It’s a therapeutic vaccine, not an immunization against the disease,” Baldwin told Dermatology Times. “This is not a vaccine that you would take in order not to get acne, but rather to stop your acne from becoming severe once it’s already moderate.”

Baldwin said a phase 1 multicenter study (NCT05131373) of Sanofi’s ORI-A-ce001 was completed, but results have yet to be published. Meanwhile, Sanofi is working on a phase 1/2 randomized, double-blind, placebo-controlled study (NCT07013747) in patients with mild acne aged 18 to 45 years, with topline results expected in 2029.^1,5

Another promising treatment direction includes microbiome-directed therapies, using targeted probiotics, prebiotics, or bacteriophages. Baldwin explained potential strategies to increase health-
associated Cutibacterium acnes strains while reducing acne-promoting strains. “Maybe combine that with a bacteriophage, which sets out to kill the type of C acnes most commonly associated with acne, put them together in one cream, and rub bacteria and viruses all over your face to reduce your acne. Sounds a little gross, but it may actually be part of the future of acne therapy,” she told Dermatology Times.

Looking Ahead

Baldwin believes that research and the pipeline hold promise for clinicians and their patients with acne, and she remains hopeful for adding to the options available to them. “I think the future is bright for [acne], and I am looking forward to what they come up with next.”

References

1. Baldwin H. Inflammatory pathways in acne & rosacea. Presented at: 2025 Elevate-Derm Fall Conference; November 12-16, 2025; Tampa, FL.
2. Eichenfield LF, DuBois JC, Gold MH, Nardo CJ, Draelos ZD; DMT310 Study Group. DMT310, a novel once-weekly topical treatment for patients with moderate-to-severe acne vulgaris: results of a phase 2b randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol. 2023;89(5):945-951. doi:10.1016/j.jaad.2023.05.070
3. Dermata’s Xyngari phase 3 trial topline data meets all primary endpoints. News release. Dermata Therapeutics. March 27, 2025. Accessed December 15, 2025. https://www.prnewswire.com/news-releases/breaking-dermatas-xyngari-phase-3-trial-topline-data-meets-all-primary-endpoints-302412922.html
4. Ascletis announces China National Medical Products Administration acceptance of new drug application for denifanstat (ASC40), a first-in-class FASN inhibitor for acne treatment. News release. Ascletis Pharma Inc. December 10, 2025. Accessed December 17, 2025. https://www.prnewswire.com/apac/news-releases/ascletis-announces-china-national-medical-products-administration-acceptance-of-new-drug-application-for-denifanstat-asc40-a-first-in-class-fasn-inhibitor-for-acne-treatment-302637707.html
5. Study to evaluate safety, efficacy and immunogenicity of acne mRNA vaccine in participants with mild acne. ClinicalTrials.gov. Updated September 5, 2025. Accessed December 17, 2025. https://www.clinicaltrials.gov/study/NCT07013747