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Journey Medical Corporation Announces Positive Topline Results from its Two Phase 3 Clinical Trials (MVOR-1 and MVOR-2) Evaluating DFD-29 for the Treatment of Papulopustular Rosacea in Adults
The Phase 3 clinical trials achieved the co-primary and all secondary endpoints and subjects completed the 16-week treatment with no significant safety issues
About this update from Journey Medical Corporation
[{"type":"text","content":"The Phase 3 clinical trials achieved the co-primary and all secondary endpoints and subjects completed the 16-week treatment with no significant safety issues DFD-29 demonstrated statistical superiority over both Oracea®(doxycycline) capsules and placebo for IGA treatment success in both studies DFD-29 demonstrated statistical superiority over both Oracea® and placebo for the reduction in the total inflammatory lesion count in both studies SCOTTSDALE, Ariz., July 11, 2023 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”), a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of FDA-approved prescription pharmaceutical products for the treatment of dermatological conditions, today 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 (“MVOR-1”) and Minocycline Versus Oracea in Rosacea-2 (“MVOR-2”), evaluating Minocycline Hydrochloride Modified Release Capsules, 40 mg (“DFD-29”) 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 Ltd. Subjects in the MVOR-1 and MVOR-2 Phase 3 clinical trials were randomized in a 3:3:2 ratio to treatment with DFD-29, Doxycycline Capsules, 40 mg (“Oracea”) or placebo once daily for 16 weeks. 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. The proportion of subjects achieving Investigator’s Global Assessment (“IGA”) treatment success in the DFD-29 group was statistically superior to those in Oracea and placebo groups. 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 t...