Clinical Dermata’s DMT310 Phase 2 clinical trial for rosacea treatment...

Dermata’s DMT310 Phase 2 clinical trial for rosacea treatment crashes but shows promising acne treatment results

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Dermata Therapeutics is a clinical-stage biotechnology company headquartered in San Diego, California. The company specializes in treating medical and aesthetic skin conditions and DMT310 is the company’s lead product candidate. 

DMT310 is the company’s first product developed through its Spongilla technology platform. The once-a-week treatment is a powder that is mixed with a fluidizing agent prior to its use and is the company’s lead asset in the treatment of moderate-to-severe rosacea. The disease generally affects people with sensitive skin and can be aggravated due to environmental and physiological factors.

However, results from the phase 2 trials for the product have exhibited less than adequate results. Despite the fact that after 4 treatments with DMT310 there was a 44% reduction in inflammatory lesion counts, results which were mirrored in the drugs DMT310 Phase 2b acne study where 45% reduction in inflammatory lesion counts were observed, they are still not what was expected. Chief Development Officer Christopher Nardo, has attributed this to high dropout and placebo response rates.

“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,” explained Nardo. “36% of DMT310 patients met the criteria for a responder on the Investigators Global Assessment scale at Week 12 but  DMT310 was not able to statistically separate from the placebo with 23% of placebo patients meeting the criteria as a responder at Week 12 as well.”

According to Dermata’s President and CEO, while these results may be disappointing, DMT310’s treatment potential for acne is still significant. The treatment demonstrated statistically significant results in Phase 2b moderate-to-severe acne study on all three co-primary endpoints. 

While the company will continue to evaluate data on DMT310’s potential as a treatment for rosacea, presently, the company is invested in using resources to prepare for the End of Phase 2 meeting with the FDA for DMT310 in moderate-to-severe acne. Smooth sailing would mean that in 2023, Dermata will be able to initiate phase 3 of the acne program. It is also possible that in the future DMT310 may exhibit qualities necessary in the treatment of other skin inflammatory diseases.

2023 will prove to be a crucial year for Dermata as money is already dwindling. When 2022 began the company had $11 million in cash which has reduced to $8.1 million as of the end of September. 

In order to minimize costs, the company is planning to partner up with runner-up asset DMT410. DMT410 is being developed for excessive sweating. The second product candidate uses the company’s Spongilla technology as a method for topical intradermal delivery of botulinum toxin in the treatment of multiple medical skin conditions.

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