An Investigational Once-Weekly Topical Drug Candidate for Moderate-to-Severe Acne
DMT310 is an investigational topical drug candidate made from Villani, Inc.’s proprietary Spongilla lacustris material, a freshwater sponge. It is applied once a week.
In 2017, Villani, Inc. licensed its Spongilla technology to Dermata Therapeutics, which developed DMT310 and completed a Phase 3 trial under the name XYNGARI™. In December 2025, Villani, Inc. terminated the license agreement with Dermata. Under the agreement, the DMT310 clinical data and regulatory rights belong to Villani, Inc. Villani, Inc. intends to continue development of DMT310.
Program Highlights
- Acne trials completed in more than 800 patients: Phase 2a (121), Phase 2b (181) and Phase 3 (520)
- STAR-1 met all three co-primary endpoints at week 12, with statistically significant differences from placebo at week 4, after four weekly applications
- Phase 2b results were published in the Journal of the American Academy of Dermatology
- At the End-of-Phase-2 meeting in 2023, FDA agreed that the Phase 3 program appeared acceptable to support a New Drug Application
- Acne affects approximately 50 million people in the United States
Proposed Mechanism of Action
DMT310 is a powder processed from Spongilla lacustris. Dermata described two components. Microscopic siliceous spicules create microchannels in the skin. In laboratory studies, the sponge’s natural compounds reduced inflammatory signals (IL-8, IL-17A and IL-17F) and inhibited lipogenesis in sebocytes, the oil-producing cells of the skin.
Clinical Development in Acne
Phase 3: STAR-1
A randomized (2:1), double-blind, placebo-controlled, 12-week trial in 520 patients aged 9 years and older with moderate-to-severe acne, conducted in the United States and Latin America. Patients applied DMT310 or placebo once a week. Topline results were reported in March 2025.
| Week 12 results (intent-to-treat) | DMT310 | Placebo | p-value |
|---|---|---|---|
| IGA success | 29.4% | 15.2% | < 0.001 |
| Inflammatory lesions, mean change | −16.8 | −13.1 | < 0.001 |
| Non-inflammatory lesions, mean change | −17.3 | −12.4 | < 0.001 |
| Inflammatory lesions, percent change | −59.1% | −45.3% | < 0.001 |
| Non-inflammatory lesions, percent change | −48.3% | −34.7% | < 0.001 |
At week 4, after four applications, all three co-primary endpoints already differed significantly from placebo (IGA success 11.9% vs. 6.2%, p < 0.05; lesion counts p < 0.001). Dermata reported no serious adverse events attributed to treatment. Results were presented at the European Academy of Dermatology and Venereology Congress 2025 (abstract P3243).
Phase 2b
A randomized, double-blind, placebo-controlled, 12-week trial in 181 patients aged 12 years and older at 14 U.S. sites. At week 12, 44.4% of DMT310 patients achieved IGA success compared with 17.8% on placebo (p < 0.001). Mean inflammatory lesion counts fell by 15.6 compared with 10.8, and non-inflammatory lesion counts by 18.3 compared with 12.4 (both p < 0.001). No serious treatment-related adverse events occurred. Eichenfield LF et al., J Am Acad Dermatol 2023;89(5):945–951
Phase 2a
A randomized trial in 121 patients, completed in 2018. It met its primary endpoint: inflammatory lesions fell by 16 with DMT310 compared with 11 with placebo (p < 0.05). Differences in non-inflammatory lesions and IGA success were not statistically significant.
Other Indications Studied
- Psoriasis, Phase 1b: in a 30-patient open-label study, 29.6% of patients reached a Physician’s Global Assessment score of 0 or 1 at week 8.
- Rosacea, Phase 2: the trial did not meet its primary endpoints.
Regulatory Status and Next Steps
At the End-of-Phase-2 meeting in 2023, FDA agreed that the overall Phase 3 program appeared acceptable to support a New Drug Application and that the three co-primary endpoints were acceptable.
In 2025, as part of its shift to over-the-counter skin care products, Dermata withdrew its investigational new drug application for DMT310. Continued development will require a new investigational new drug application. The remaining steps before a New Drug Application include a second Phase 3 trial, a long-term extension study, and the remaining nonclinical studies.
Development Milestones
- 2017: Villani, Inc. licenses its Spongilla technology to Dermata Therapeutics
- 2018: Phase 2a acne trial meets its primary endpoint
- 2020: Phase 2b acne trial results reported
- 2021: Phase 1b psoriasis study results reported
- 2022: Phase 2 rosacea trial does not meet its primary endpoints
- 2023: Phase 2b results published in the Journal of the American Academy of Dermatology; End-of-Phase-2 meeting with FDA
- 2025: STAR-1 Phase 3 topline results reported (March); Dermata withdraws the IND; Villani, Inc. terminates the license agreement (December)
Partnering
Villani, Inc. welcomes inquiries from pharmaceutical companies and other parties interested in partnering on the continued development of DMT310. Contact us
DMT310 is an investigational drug and has not been approved by the U.S. Food and Drug Administration. XYNGARI™ is a trademark of Dermata Therapeutics, Inc.