Journey Medical (DERM) presented data assessing the dermal and systemic pharmacokinetics of oral DFD-29 versus oral Doxycycline 40 mg capsules in healthy subjects at the 44th Fall Clinical Dermatology Conference that is taking place October 24-27, 2024, in Las Vegas, NV. DFD-29 is being developed for the treatment of rosacea in collaboration with Dr. Reddy’s Laboratories (RDY). Claude Maraoui, CEO, stated, “Based on the robust safety and efficacy data seen throughout all our clinical trials, we believe DFD-29 can change the treatment landscape for the millions of patients suffering from rosacea. We submitted a New Drug Application to the U.S. Food and Drug Administration for DFD-29 earlier this year and look forward to the upcoming PDUFA date of November 4, 2024. If approved, DFD-29 has the potential to be the lowest fixed-dose minocycline and the best-in-class therapy for rosacea patients.” This randomized, open-label, single-center, parallel-group study evaluated the systemic and dermal PK of once-daily administration of oral DFD-29 40 mg capsules versus oral doxycycline 40 mg for 21 days in healthy adult volunteers. Plasma PK parameters were similar on Day 1 and Day 21 for minocycline, but doxycycline showed accumulation in the plasma with a significant increase in PK parameters from Day 1 to Day 21. Mean dermal Cmax and AUC for minocycline reached maximum levels on Day 1 and remained at a high level until Day 21, while doxycycline started with low levels on Day 1 and attained peak on Day 21. Minocycline had significantly higher levels than doxycycline in the skin both on Day 1 and Day 21. Both DFD-29 and doxycycline were well tolerated by the healthy volunteers.
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