Proof of Concept Study Supports Dermata’s Topical Delivery Mechanism for Botulinum Toxin
DMT410 is a combination regimen for the treatment of skin diseases and aesthetic conditions. DMT310 is first topically applied to the skin, followed by topical application of botulinum toxin.
Dermata Therapeutics’ DMT410 (DMT310 + botulinum toxin) performed well in a Phase 1proof of concept study for the treatment of primary axillary hyperhidrosis, the Company reports.
DMT410 is a combination regimen for the treatment of skin diseases and aesthetic conditions. DMT310 is first topically applied to the skin, followed by topical application of botulinum toxin.
"This study provides convincing evidence that DMT310, our Spongilla lacustris powder with millions of microscopic needle-like spicules, is effective in creating channels through the stratum corneum for biologics to enter the dermis, resulting in effects similar to injections," says Gerry Proehl, President and CEO of Dermata Therapeutics, LLC, in a news release.
In the Phase 1 DMT410 Hyperhidrosis trial, 10 patients were enrolled at one site, in an open-label, 2-arm, 4-week study. Each patient had a baseline of at least 50mg of sweat production in each axilla. Each axilla received topical application of DMT310 powder reconstituted with either hydrogen peroxide or sterile saline massaged onto the skin. After application of the DMT310 was washed off, both axillae then received topical application of BTX, reconstituted per its label, by massaging it into the same treatment area of each axilla.
The primary endpoints were the percent of patients with greater than 50 percent reduction in gravimetrically measured sweat production from baseline; the percent of patients with gravimetric sweat production less than 50mg; and the mean absolute change from baseline in gravimetrically measured sweat production. At Day 29, 80 percent of patients achieved an overall decrease in gravimetric sweat production of greater than 50 percent; 85 percent of patients achieved a gravimetric sweat production of less than 50mg; and the mean absolute change in gravimetric sweat production was -114.64mg.
DMT410 was well tolerated with only two adverse events, and only one related to treatment. These results demonstrate DMT410's clinically meaningful effects in reducing hyperhidrosis symptoms similar to results from BOTOX® injections for hyperhidrosis.
"We are very encouraged with these results and the multiple other biologic combination therapy opportunities this presents for DMT400," says Christopher Nardo, PhD, Dermata’s Senior VP of Development. "There are many potential benefits of using DMT310 as a dermal delivery mechanism for not only botulinum toxin but also other biologics. We believe this provides the potential for lower systemic drug exposure, greater patient acceptance due to the injection-free delivery, and the possibility to expand the use of biologics to patients with milder disease."