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Dermata Announces Topline Results from DMT310 Phase 2 Clinical Trial for the Treatment of Moderate-to-Severe Rosacea
- Data supportive of DMT310 as a treatment for inflammatory skin diseases, but rosacea study did not meet primary endpoints -- DMT310 produced no serious
About this update from Dermata Therapeutics, Inc.
[{"type":"text","content":"- Data supportive of DMT310 as a treatment for inflammatory skin diseases, but rosacea study did not meet primary endpoints -- DMT310 produced no serious adverse events related to treatment -- Dermata remains on track to request an End of Phase 2 meeting with the FDA for DMT310 for the treatment of acne in the first quarter of 2023 -SAN DIEGO, CA / ACCESSWIRE / December 5, 2022 / Dermata Therapeutics, Inc. (\"Dermata\" or the \"Company\") (Nasdaq:DRMA)(DRMAW), a clinical-stage biotechnology company focusing on the treatment of medical and aesthetic skin conditions, today announced topline results from its Phase 2 trial of once-weekly topical application of DMT310 for the treatment of moderate-to-severe rosacea. DMT310 is Dermata's lead product candidate, with both mechanical and chemical mechanisms of action, with positive Phase 2 data in moderate-to-severe acne and Phase 1b data in mild-to-moderate psoriasis.\"While the final data were not what we had hoped for, we were encouraged to see a 44% reduction in inflammatory lesion counts after just 4 treatments with DMT310, which mirrors the 45% reduction in inflammatory lesion counts we saw in our DMT310 Phase 2b acne study,\" stated Christopher Nardo Ph.D., Dermata's Chief Development Officer. \"We believe the above average dropout rate of 23% for patients treated with DMT310 seen in this rosacea study, versus 13% seen in the Phase 2b acne study, could explain the reduced treatment effect of DMT310 at Week 12. Rosacea is a complicated skin disease that affects patients with sensitive skin and the disease waxes and wanes with environmental and physiological exposures. Some patients did achieve a meaningful change in their rosacea with 36% of DMT310 patients meeting the criteria for a responder on the Investigators Global Assessment scale at Week 12. However, DMT310 was not able to statistically separate from placebo with 23% of placebo patients meeting the criteria as a responder at Week 12,\" continued Dr. Nardo. \"A treatment responder is defined as an IGA grade of ‘clear' or ‘almost clear' and at least a 2-grade improvement from baseline. Lastly, we want to thank the patients and investigators who participated in this study.\"\"While we are disappointed with the results in rosacea, we are still encouraged by DMT310's treatment potential for acne, as we have seen a highly statist...