Journey Medical Corporation Announces 50% Enrollment Milestone Achieved in Phase 3 Clinical Trials Evaluating DFD-29 (Minocycline Modified Release Capsules 40 mg) for the Treatment of Papulopustular Rosacea

About this update from Journey Medical Corporation

[{"type":"text","content":"Topline data expected in the first half of 2023\nSCOTTSDALE, Ariz., Aug. 30, 2022 (GLOBE NEWSWIRE) -- Journey Medical Corporation (NASDAQ: DERM) (“Journey Medical”), a commercial-stage biopharmaceutical company that focuses on the development and commercialization of pharmaceutical products for the treatment of dermatological conditions, today announced that it has enrolled and randomized over 50 percent 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. Claude Maraoui, Co-Founder, President and Chief Executive Officer of Journey Medical, stated, “We are very pleased to have enrolled over 50 percent of the patients in our DFD-29 Phase 3 clinical program, an important milestone for Journey Medical. In a Phase 2 multicenter clinical trial, DFD-29 achieved nearly double the efficacy compared to doxycycline capsules 40 mg on reducing total inflammatory lesions and Investigator’s Global Assessment (“IGA”) treatment success. As such, data to date suggests the potential of DFD-29 as a more effective treatment option that we hope to provide for the millions of patients worldwide who suffer with rosacea. We look forward to announcing topline data in the first half of 2023, with a New Drug Application (“NDA”) filing subsequently expected in the second half of 2023. After approval, we anticipate DFD-29 achieving peak annual net sales in excess of $100 million.” 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 Oracea® in Rosacea), that we expect to support an NDA submission in the United States and potentially a Marketing Authorization Application in Europe. Over 50 percent of the combined enrollment target of 640 total adult patients with moderate to severe papulopustular rosacea (“PPR”) have been enrolled in the trials; one trial is enrolling patients in the United States, and the other is enrolling patients in both the United States and Europe. The MVOR-01 and MVOR-02 clinical tri...

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