Journey Medical Corporation shared 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.

The PK study was designed as a single-center, randomized, open-label, single-dose, three-treatment, crossover, comparative bioavailability study of DFD-29 (Minocycline Modified Release Capsules 40mg) compared to Solodyn (Minocycline Modified Release Tablets 105mg). 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 with Solodyn 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. 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 (40mg) was significantly lower than that of Solodyn. Additionally, the study showed that food did not have a significant effect on the pharmacokinetics of DFD-29.

“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 in the second half of 2023. We hope to show the potential of DFD-29 as an effective treatment option for the millions of patients worldwide who suffer with rosacea," says Claude Maraoui, Co-Founder, President and Chief Executive Officer of Journey Medical, in a news release,