Journey Medical Corporation Announces Presentation of Data from Phase 1 Clinical Trial Assessing the Impact of DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) on Microbial Flora of Healthy Adults at 2024 AAD Annual Meeting

Clinical trial achieved all three primary objectives and subjects completed 16-week treatment with no significant safety issues

Results indicate that DFD-29 can be safely used for up to 16 weeks with no detectable effects on microbiota in the skin, GI tract, or vagina

New Drug Application for DFD-29 currently under review by U.S. FDA

SCOTTSDALE, Ariz., March 11, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”), a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of FDA-approved prescription pharmaceutical products for the treatment of dermatological conditions, announces that data from the Phase 1 clinical trial (DFD-29-CD-006) assessing the impact of DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) on the microbial flora of healthy adults were presented at the 2024 American Academy of Dermatology (AAD) Annual Meeting that took place March 8-12, 2024, in San Diego, CA. The clinical trial also assessed the safety and tolerability of the treatment. The data were presented by Srinivas Sidgiddi, M.D., Vice President, Research & Development of Journey Medical. DFD-29 is being developed for the treatment of rosacea in collaboration with Dr. Reddy’s Laboratories Ltd.

Claude Maraoui, Co-Founder, President, and Chief Executive Officer of Journey Medical, stated, “We are encouraged by the data presented at the AAD meeting as they demonstrate that DFD-29 can be safely used for up to 16 weeks with no significant risk of microbiota suppression or development of resistance. Based on the robust safety and efficacy data seen throughout all of our clinical trials, we believe that DFD-29 has the potential to change the treatment landscape for the millions of patients suffering from rosacea. If approved, DFD-29 has potential to be best-in-class and the only oral medication to address both inflammatory lesions and erythema (redness) from rosacea.”

DFD-29-CD-006 is a multicenter, randomized, double-blind, placebo-controlled, parallel group study that enrolled 60 healthy, adult subjects (30 males and 30 females) in a 2:1 randomization between DFD-29 and placebo. Treatment was administered once daily orally over 16 weeks. Microbiological samples were collected from the skin (forehead), stool and vagina at multiple timepoints through the study. The study achieved all primary objectives and no significant safety issues were noted during the study. Additional information on the DFD-29 Phase 1 clinical trial can be found on ClinicalTrials.gov using the identifier NCT05597462.