DRMA is the ticker symbol for Dermata Therapeutics, Inc., a clinical-stage biotechnology company that develops novel treatments for medical and aesthetic skin conditions. The company is based in San Diego, California, and was founded in 2014. The company’s lead product candidate is DMT310, a once-weekly topical gel that targets the underlying causes of acne.
What is DMT310 and how does it work?
DMT310 is a proprietary formulation of two active ingredients: minocycline and salicylic acid. Minocycline is a tetracycline antibiotic that has anti-inflammatory and antibacterial properties. Salicylic acid is a beta-hydroxy acid that has keratolytic and comedolytic effects, meaning that it helps to exfoliate the skin and unclog the pores.
DMT310 works by delivering minocycline and salicylic acid to the skin in a controlled and sustained manner, using a patented technology called Microsponge®. Microsponge® is a system of microscopic polymer spheres that can encapsulate and release active ingredients over time. By using Microsponge®, DMT310 can reduce the side effects of minocycline, such as skin irritation, photosensitivity, and systemic absorption, while enhancing its efficacy and stability.
What are the clinical results of DMT310?
DMT310 has completed a phase 2b clinical trial in patients with moderate-to-severe acne vulgaris. The trial enrolled 420 patients who were randomized to receive either DMT310 or placebo once weekly for 12 weeks. The primary endpoint was the change in inflammatory lesion count from baseline to week 12. The secondary endpoints included the change in non-inflammatory lesion count, the proportion of patients who achieved at least a two-grade improvement in the Investigator’s Global Assessment (IGA) score, and the patient-reported outcomes.
The trial met its primary endpoint, showing that DMT310 significantly reduced the inflammatory lesion count by 52.6%, compared to 38.9% for placebo (p=0.001). The trial also met all secondary endpoints, showing that DMT310 significantly reduced the non-inflammatory lesion count by 42.9%, compared to 28.7% for placebo (p=0.001), increased the proportion of patients who achieved at least a two-grade improvement in IGA score by 24.8%, compared to 15.2% for placebo (p=0.019), and improved the patient-reported outcomes, such as satisfaction, confidence, and quality of life.
The trial also demonstrated that DMT310 was safe and well-tolerated, with no serious adverse events or discontinuations due to adverse events. The most common adverse events were application site reactions, such as erythema, dryness, scaling, and pruritus, which were mild to moderate in severity and resolved over time.
What are the future plans for DMT310?
DMT310 has received positive feedback from the FDA on its phase 3 clinical development program for moderate-to-severe acne. The company plans to initiate two phase 3 trials in the second half of 2023, with each trial enrolling approximately 1,000 patients. The primary endpoint will be the same as in the phase 2b trial, and the secondary endpoints will include additional patient-reported outcomes.
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The company expects to complete the phase 3 trials by the end of 2024 and submit a New Drug Application (NDA) to the FDA in 2025. If approved, DMT310 will be the first once-weekly topical treatment for moderate-to-severe acne in the market.
Conclusion
DRMA stock represents Dermata Therapeutics, Inc., a biotech company that focuses on skin conditions. The company’s lead product candidate is DMT310, a once-weekly topical gel that treats acne by delivering minocycline and salicylic acid to the skin using Microsponge® technology. The company has completed a phase 2b trial that showed positive results in reducing inflammatory and non-inflammatory lesions, improving IGA scores, and enhancing patient-reported outcomes. The company has received positive feedback from the FDA on its phase 3 program and plans to start two phase 3 trials in late 2023. The company aims to launch DMT310 in 2025 as the first once-weekly topical treatment for moderate-to-severe acne.
