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Journey Medical Corporation Announces Positive Comparative Pharmacokinetic (PK) Data for DFD-29
Phase 3, registrational studies remain on track for first half of 2023 topline data readout SCOTTSDALE, Ariz., Dec. 20, 2022 (GLOBE NEWSWIRE) -- Journey
About this update from Journey Medical Corporation
[{"type":"text","content":"Phase 3, registrational studies remain on track for first half of 2023 topline data readout\nSCOTTSDALE, Ariz., Dec. 20, 2022 (GLOBE NEWSWIRE) -- Journey Medical Corporation (NASDAQ: DERM) (“Journey Medical”), a commercial-stage biopharmaceutical company focused on the development and commercialization of pharmaceutical products for the treatment of dermatological conditions, today announced positive PK comparability data of DFD-29 and key updates on the progress of its pivotal, Phase 3 clinical study of DFD-29 for the treatment of papulopustular rosacea in collaboration with Dr. Reddy’s Laboratories Ltd. (“Dr. Reddy’s”). The PK study was designed as a single-center, randomized, open-label, single-dose, three-treatment, crossover, comparative bioavailability study of Journey Medical’s DFD-29 (Minocycline Modified Release Capsules 40 mg) versus SOLODYN® (Minocycline Modified Release Tablets 105 mg). A total of 24 healthy adult volunteers were enrolled and examined for up to 30 days. The primary objectives of the study were to assess: 1) the comparative bioavailability of DFD-29 (Minocycline MR Capsules 40 mg) with SOLODYN® (Minocycline MR Tablets 105 mg) following a single oral dose administration under fasting conditions in healthy adult human subjects; and 2) the effect of food on the bioavailability of DFD-29 (Minocycline MR Capsules 40 mg). The secondary objective of the study was to evaluate and compare the safety and tolerability profiles of each study treatment. The study successfully demonstrated that the systemic exposure of DFD-29 (40 mg) was significantly lower than that of SOLODYN (105 mg). Additionally, the study showed that food did not have a significant effect on the pharmacokinetics of DFD-29. Claude Maraoui, Co-Founder, President and Chief Executive Officer of Journey Medical, stated, “We are pleased to continue advancing the DFD-29 clinical program as part of our collaboration with Dr. Reddy’s. The PK data indicate the safety of DFD-29 is on par with SOLODYN. To date, the enrollment of our pivotal, Phase 3 program has reached 96 percent. We look forward to providing further updates on the DFD-29 program including potential topline data from the Phase 3 studies, anticipated in the first half of 2023. Journey Medical also plans to file a New Drug Application (“NDA”) in the second half of 2023. We hope to show the...