Journey Medical Corporation announced that it has fully enrolled and randomized all of the patients in its Phase 3 clinical program to assess the safety, efficacy and tolerability of DFD-29 (Minocycline Modified Release Capsules 40 mg) for the treatment of papulopustular rosacea. The Phase 3 clinical trials are part of a collaboration with Dr. Reddy's Laboratories Ltd. for the ongoing development and commercialization of the DFD-29 program. The DFD-29 Phase 3 clinical program consists of two multicenter, randomized, double-blind, parallel-group, active-comparator and placebo-controlled clinical trials, MVOR-01 and MVOR-02 (Minocycline versus Oraceain Rosacea), that are expected to support an NDA submission in the United States and potentially 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-01 and MVOR-02 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. Data published in The Journal of Clinical and Aesthetic Dermatology determined DFD-29 40 mg demonstrated significantly greater efficacy than doxycycline 40 mg, placebo and DFD-29 20 mg for the treatment of PPR in a Phase 2 clinical study.

DFD-29 40 mg demonstrated statistical significance compared to both placebo and doxycycline 40 mg on both co-primary endpoints—proportion of subjects with IGA treatment success (grade 0 or 1 with at least a two-grade reduction from baseline at week 16) and total inflammatory lesion count reduction from baseline to week 16. Additional information on the DFD-29 Phase 3 clinical trial program can be found on ClinicalTrials.gov using the identifiers: NCT05296629 and NCT05343455. About Rosacea: Rosacea is a chronic, relapsing, inflammatory skin condition that most commonly presents with symptoms such as deep facial redness, acne-like inflammatory lesions (papules and pustules) and spider veins (telangiectasia).

According to The National Rosacea Society, it is estimated that rosacea affects well over 16 million Americans and as many as 415 million worldwide. Rosacea is most frequently seen in adults between 30 and 50 years of age. Surveys conducted by The National Rosacea Society report more than 90% of rosacea patients said their condition had lowered their self-confidence and self-esteem, and 41 percent reported that it had caused them to avoid public contact or cancel social engagements.

Among rosacea patients with severe symptoms, 88% said the disorder had adversely affected their professional interactions, and 51% said they had missed work because of their condition.