Journey Medical says Phase 1 trial of DFD-29 achieved all primary objectives

Journey Medical (DERM) announced topline data from the Phase 1 clinical trial assessing the impact of DFD-29 on the microbial flora of healthy adults. The clinical trial also assessed the safety and tolerability of the treatment. DFD-29 is being developed for the treatment of papulopustular rosacea in collaboration with Dr. Reddy’s Laboratories (RDY). DFD-29-CD-006 is a multi-center, randomized, double-blind, placebo-controlled, parallel group study that enrolled 60 healthy, adult subjects 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, 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. Treatment with DFD-29 for 16 weeks did not produce significant negative impact on the normal microbial flora and did not induce significant bacterial resistance. Additionally, treatment with DFD-29 did not cause significant proliferation of opportunistic organisms. The results indicate that DFD-29 can be safely used for up to 16 weeks with no significant risk of microbiota suppression or development of resistance. 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, that are expected to support a New Drug Application 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 enrolled patients in the United States, and the other enrolled 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, Oracea 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. To date, no major safety issues have been reported, and no drug-related serious adverse events have been observed.