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Journey Medical Corporation Announces First Patient Dosed in Phase 3 Clinical Trial Evaluating DFD-29 (Minocycline Modified Release Capsules 40 mg) for the Treatment of Rosacea
Published Phase 2 clinical data show DFD-29 had approximately double the efficacy compared to Doxycycline capsules 40 mg on reducing total inflammatory
About this update from Journey Medical Corporation
[{"type":"text","content":"Published Phase 2 clinical data show DFD-29 had approximately double the efficacy compared to Doxycycline capsules 40 mg on reducing total inflammatory lesions and IGA treatment success\nSCOTTSDALE, Ariz., March 17, 2022 (GLOBE NEWSWIRE) -- Journey Medical Corporation (NASDAQ: DERM) (“Journey Medical”), a commercial-stage pharmaceutical company that focuses on the development and commercialization of pharmaceutical products for the treatment of dermatological conditions, today announced that the first patient has been dosed in a Phase 3 clinical trial 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. (“Dr. Reddy’s”) for the ongoing development and commercialization of the DFD-29 program. Two multicenter, randomized, double-blind, parallel-group, active and placebo-controlled Phase 3 clinical trials will each enroll up to 320 adult patients with moderate to severe papulopustular rosacea (“PPR”). One trial is enrolling patients in the United States and the other is enrolling in the United States and Europe. The studies will be 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 of the studies 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). Claude Maraoui, Co-Founder, President and Chief Executive Officer of Journey Medical, stated, “Reaching this milestone marks another important inflection point for Journey Medical. We began as a commercial-stage pharmaceutical company and have evolved into a fully-integrated pharmaceutical company with a research and development division that has the capability to expand available dermatologic treatment options. Research to date demonstrates the potential of DFD-29 as a more effective treatment option that we hope to provide for the millions of patients worldwide that suffer with rosacea.” Research published in The Journal of Clinical and Aesthetic Dermatology in December 20...