Journey Medical to announce results from Phase 3 DFD-29 trials week of July 10

Journey Medical announced that it expects topline results from the two Phase 3 multicenter, randomized, double-blind, parallel-group, active-comparator and placebo-controlled clinical trials, MVOR-1 and MVOR-2, evaluating DFD-29 for the treatment of moderate to severe papulopustular rosacea, to be announced the week of July 10, 2023. DFD-29 is being developed for the treatment of PPR in collaboration with Dr. Reddy’s Laboratories Ltd. 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.