Dermata Therapeutics, Inc. and Revance Therapeutics, Inc. are partnering for a clinical trial collaboration agreement to evaluate the topical application of Xyngari (formerly known as DMT310), Dermata’s topical Spongilla powder, with daxibotulinumtoxinA-lanm (Daxxify), Revance’s botulinum toxin type A.
The Companies intend to first evaluate Xyngari with for the topical treatment of primary axillary hyperhidrosis and may explore additional indications through a broader partnership in the future.
“We are excited to partner with Revance to further clinical development of our unique program, using our Xyngari product for a needle-free, intradermal delivery of a botulinum toxin, like Daxxify, to the dermis,” says Gerald Proehl, Chairman, President, and Chief Executive Officer of Dermata, in a news release. “This clinical development collaboration will provide the cooperative framework to fully evaluate the treatment effect of Xyngari with Daxxify for treating hyperhidrosis and potentially additional medical and aesthetic indications. We believe that the unique broad coverage ability of Xyngari, with a long-lasting botulinum toxin like Daxxify, could provide patients with a potentially superior treatment option than current injections of a botulinum toxin with a needle.”
“Revance is excited to partner with Dermata to jointly explore the potential for Daxxify and Xyngari for the needle-free treatment of axillary hyperhidrosis and to expand the opportunities for Daxxify beyond injections,” says Mark Foley, Chief Executive Officer of Revance.
Phase 2a Clinical Trial Design
The Phase 2a clinical trial will evaluate the efficacy, safety, and tolerability of Xyngari and Daxxify versus Xyngari and placebo in patients with moderate-to-severe axillary hyperhidrosis for 16 weeks. The trial will be randomized (1:1:1:1), double-blind, placebo-controlled, enrolling approximately 48 patients across sites in the United States. The endpoints will be the percent of patients with greater than 50% 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. Patients will be evaluated at four regular intervals.
Daxxify has received approval in the United States for specific uses in treating moderate to severe glabellar lines and cervical dystonia, while Xyngari is currently in a Phase 3 clinical program in moderate-to-severe acne. Daxxify’s proprietary formulation is manufactured without the use of animal or human proteins and contains highly purified 150 kDa core neurotoxin and the patented peptide excipient RTP004.
