Dermata Therapeutics, Inc. (Nasdaq: DRMA), a late-stage biotechnology company focused on medical and aesthetic skin conditions, reported encouraging enrollment progress for its Phase 3 Spongilla Treatment of Acne Research (STAR-1) clinical trial during its first quarter 2024 financial update.
"We are very encouraged by the enrollment numbers to date of our STAR-1 clinical trial in acne and we are on track to complete enrollment by the end of 2024," stated Gerry Proehl, Dermata's Chairman, President, and Chief Executive Officer. "With very few competing Phase 3 acne studies, we are confident in our team's ability to get our STAR-1 study fully enrolled this year."
DMT310: A Novel Approach to Acne Treatment
DMT310 represents Dermata's lead candidate from its proprietary Spongilla technology platform. The once-weekly topical treatment, derived from naturally sourced freshwater sponge, employs multiple unique mechanisms of action to target moderate-to-severe acne.
The STAR-1 trial, which began enrolling patients in December 2023, is the first of two required Phase 3 studies before the company can submit a new drug application (NDA). Approximately 550 patients with moderate-to-severe acne will be followed for 12 weeks to evaluate the efficacy, safety, and tolerability of once-weekly DMT310 treatments compared to placebo.
Based on current enrollment projections, Dermata expects to report topline results from STAR-1 in the first quarter of 2025. If successful, the company plans to quickly initiate the second Phase 3 study.
"If positive, we believe this would put us in a strong position to initiate the second Phase 3 study quickly thereafter, while we also explore potential partnership opportunities for DMT310," Proehl noted. "Based on recent findings in the acne space, we believe if DMT310 is approved as a once-weekly topical acne treatment, it could be a first-line treatment option for the over 32 million diagnosed patients suffering from acne in the US."
DMT410 Program Advances with Patent Protection
In parallel with its acne program, Dermata continues to make progress on partnership discussions for its DMT410 program, which utilizes the company's Spongilla technology to facilitate intradermal delivery of botulinum toxin through topical application rather than injections.
The company recently received issuance of a Japanese patent for DMT410 for the treatment of hyperhidrosis, strengthening its intellectual property portfolio. DMT410 has successfully completed proof-of-concept Phase 1 clinical trials in combination with BOTOX® for both primary axillary hyperhidrosis and multiple aesthetic skin conditions.
Financial Position
As of March 31, 2024, Dermata reported $4.7 million in cash and cash equivalents, compared to $7.4 million at the end of 2023. The company expects current resources to fund operations into the third quarter of 2024.
Research and development expenses increased to $1.6 million for Q1 2024, up from $1.2 million in Q1 2023, primarily due to increased clinical trial expenses from the STAR-1 study and higher stock-based compensation. General and administrative expenses also rose to $1.6 million from $1.1 million in the same period last year, driven by increased stock-based compensation and public company costs.
Clinical Development Strategy
Dermata's clinical development strategy for DMT310 builds on positive data observed in its Phase 2b acne study. The company has designed the Phase 3 program to detect statistically significant differences in primary endpoints between once-weekly DMT310 treatments and placebo.
If the Phase 3 program proves successful, Dermata intends to submit an NDA to the FDA seeking regulatory approval of DMT310 for moderate-to-severe acne. The company reached final agreement with the FDA to proceed with the Phase 3 clinical program after submitting amended protocols and demonstrating sufficient chemistry, manufacturing, and controls.
Market Opportunity
Acne represents a significant market opportunity, affecting over 32 million diagnosed patients in the United States alone. Current treatment options often require daily application or oral medications with potential side effects. DMT310's once-weekly application schedule could offer a competitive advantage if approved.
Similarly, the DMT410 program addresses unmet needs in hyperhidrosis and aesthetic dermatology by potentially enabling topical delivery of botulinum toxin without injections, which could expand the market for these treatments.
"It is an enormous accomplishment for our team to have successfully initiated the first of two DMT310 Phase 3 clinical studies in acne," Proehl commented. "We feel confident that based on the positive data observed in our DMT310 Phase 2b acne study that we have powered and designed the Phase 3 clinical studies to sufficiently detect a statistically significant difference in the primary endpoints of once weekly treatments of DMT310 when compared with placebo."
