Journey Medical achieved co-primary endpoints in MVOR-1, MVOR-2 studies

Journey Medical Corporation (DERM) announced positive topline results from the two Phase 3 multicenter, randomized, double-blind, parallel-group, active-comparator and placebo-controlled clinical trials, Minocycline Versus Oracea in Rosacea-1 and Minocycline Versus Oracea in Rosacea-2, evaluating Minocycline Hydrochloride Modified Release Capsules, 40 mg for the treatment of moderate-to-severe papulopustular rosacea in adults. DFD-29 is being developed for the treatment of rosacea in collaboration with Dr. Reddy’s Laboratories (RDY). The primary objective of both studies was to evaluate the safety and efficacy of DFD-29 compared to placebo for the treatment of papulopustular rosacea. The secondary objective was to evaluate the safety and efficacy of DFD-29 compared to Oracea. Both clinical trials achieved the co-primary and all secondary endpoints, which compared the efficacy of DFD-29 to Oracea and placebo for the treatment of rosacea. Additionally, the reduction in the total inflammatory lesion count from baseline to week 16 in the DFD-29 group was statistically superior to Oracea and placebo groups. There were no major safety issues and no serious adverse events related to study products in both MVOR-1 and MVOR-2 trials. The number of treatment emergent adverse events and their severity were similar between the treatment groups. The number of TEAEs related to study products were also similar between the groups.