Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”), a commercial-stage biopharmaceutical company that focuses on the development and commercialization of pharmaceutical products for the treatment of dermatological conditions, today announced completion of treatment in the Phase 1 clinical trial assessing the impact of DFD-29 (Minocycline Modified Release Capsules 40 mg) on the microbial flora of healthy adults. The clinical trial is also assessing the safety and tolerability of the treatment. DFD-29 is being developed for the treatment of papulopustular rosacea (“PPR”) in collaboration with Dr. Reddy’s Laboratories Ltd.

DFD-29-CD-006 is a multi-center, 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. 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.

Claude Maraoui, Co-Founder, President and Chief Executive Officer of Journey Medical, stated, “DFD-29 continues to make positive progress in the clinic, bringing us closer to potentially providing a new treatment option for the millions of patients suffering from rosacea. We expect to report topline results from the Phase 1 trial in the first half of 2023. In addition, we are pleased that the DFD-29 Phase 3 clinical trials have been fully enrolled as of January 2023. We anticipate topline data from the Phase 3 clinical trials in the first half of 2023, with a New Drug Application filing subsequently expected in the second half of 2023.”

The DFD-29 Phase 3 clinical program consists of two multicenter, randomized, double-blind, parallel-group, active-comparator and placebo-controlled clinical trials, MVOR-1 and MVOR-2 (Minocycline versus Oracea® in Rosacea), that are expected to support a New Drug Application (NDA) submission in the United States and a Marketing Authorization Application in Europe. The combined enrollment target of 640 total adult patients with moderate to severe PPR was achieved in the trials; one trial was enrolling patients in the United States, and the other was enrolling patients in both the United States and Europe. The MVOR-1 and MVOR-2 clinical trials are randomized in a 3:3:2 ratio to DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg), Oracea® (Doxycycline capsules 40 mg) or placebo once daily for 16 weeks. The primary objective is to evaluate the safety, efficacy and tolerability of DFD-29 compared to placebo for the treatment of PPR. The secondary objective is to evaluate the safety, efficacy and tolerability of DFD-29 compared to Oracea® (Doxycycline capsules 40 mg). To date, no major safety issues have been reported, and no drug-related serious adverse events have been observed.