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Journey Medical Corporation Announces Positive Topline Data from Phase 1 Clinical Trial Assessing the Impact of DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) on Microbial Flora of Healthy Adult Subjects
Clinical trial achieved all three primary objectives and subjects completed 16-week treatment with no significant safety issues Results indicate that DFD-29
About this update from Journey Medical Corporation
[{"type":"text","content":"Clinical trial achieved all three primary objectives and subjects completed 16-week treatment with no significant safety issues Results indicate that DFD-29 can be safely used for up to 16 weeks with no significant risk of microbiota suppression or development of resistance Topline data from Phase 3 clinical trials are anticipated in June 2023; New Drug Application filing subsequently expected in the second half of 2023 SCOTTSDALE, Ariz., June 13, 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 data from the Phase 1 clinical trial assessing the impact of DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) on the microbial flora of healthy adults. The clinical trial also assessed the safety and tolerability of the treatment. DFD-29 is being developed for the treatment of papulopustular rosacea (“PPR”) in collaboration with Dr. Reddy’s Laboratories Ltd. DFD-29-CD-006 is a multi-center, randomized, double-blind, placebo-controlled, parallel group study that enrolled 60 healthy, adult subjects (30 males and 30 females) in a 2:1 randomization between DFD-29 and placebo. Treatment was administered once daily orally over 16 weeks. Microbiological samples were collected from the skin (forehead), stool and vagina at multiple timepoints through the study. The study achieved all primary objectives and no significant safety issues were noted during the study. Treatment with DFD-29 for 16 weeks did not produce significant negative impact on the normal microbial flora and did not induce significant bacterial resistance. Additionally, treatment with DFD-29 did not cause significant proliferation of opportunistic organisms. The results indicate that DFD-29 can be safely used for up to 16 weeks with no significant risk of microbiota suppression or development of resistance. Additional information on the DFD-29 Phase 1 clinical trial can be found on ClinicalTrials.gov using the identifier NCT05597462. Claude Maraoui, Co-Founder, President and Chief Executive Officer of Journey Medical, stated, “We are very pleased with the topline results of this Phase 1 clinical tri...