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Journey Medical Corporation Completes Enrollment in Phase 3 Clinical Trials Evaluating DFD-29 (Minocycline Modified Release Capsules 40 mg) for the Treatment of Papulopustular Rosacea
Topline data expected in the first half of 2023 SCOTTSDALE, Ariz., Jan. 10, 2023 (GLOBE NEWSWIRE) -- Journey Medical Corporation (NASDAQ: DERM) (“Journey
About this update from Journey Medical Corporation
[{"type":"text","content":"Topline data expected in the first half of 2023\nSCOTTSDALE, Ariz., Jan. 10, 2023 (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 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 (“PPR”). 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 thrilled to have completed enrollment in our two DFD-29 Phase 3 clinical trials and 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. We are extremely grateful to the patients, physicians and their research teams participating in these clinical trials, as they are essential to the development of a new treatment option for the millions of patients worldwide who suffer with rosacea. Data from the Phase 2 multicenter clinical trial demonstrated that 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, suggesting the potential of DFD-29 as a more effective treatment option for rosacea. After approval, we anticipate DFD-29 achieving peak annual net sales exceeding $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 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 bot...