Study demonstrated systemic exposure of DFD-29 was significantly lower than that of Solodyn (105 mg)
Data presented at 43rd Annual Fall Clinical Dermatology Conference
New Drug Application submission to FDA for DFD-29 anticipated in the fourth quarter of 2023
SCOTTSDALE, Ariz., Oct. 20, 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 data from a comparative bioavailability (bridging) study of DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) vs. Solodyn® (Minocycline Hydrochloride Extended-Release Tablets, 105 mg). DFD-29 is being developed for the treatment of rosacea in collaboration with Dr. Reddy’s Laboratories Ltd. The data were presented at the 43rd Annual Fall Clinical Dermatology Conference taking place in Las Vegas, NV.
“The results of this bioavailability study successfully demonstrate that the systemic exposure of minocycline with DFD-29 (40 mg) was significantly lower than that of Solodyn (105 mg),” said Srinivas Sidgiddi, M.D., Vice President, Research & Development of Journey Medical. “We’re also encouraged by DFD-29’s safety profile demonstrated throughout our ongoing development program.”
The single-center, randomized, open-label, laboratory-blinded, three-way, six-sequence crossover study enrolled 24 healthy subjects with three objectives: 1) to assess the comparative bioavailability of DFD-29 vs. Solodyn (105 mg), 2) to evaluate the impact of food on DFD-29 bioavailability and 3) to evaluate the safety and tolerability profile of DFD-29. The mean age of the subjects was 42.4 years, 87% male (n=20), 78.3% Caucasian (n=18) and 78.3% were not Hispanic or Latino (n=18).
The study compared the pharmacokinetics of a single dose of: 1) DFD-29 after an overnight fast of ≥10.5 hours; 2) DFD-29 after an overnight fast of ≥10.5 hours and 30 minutes after the start of a high-fat, high-calorie breakfast; and 3) Solodyn (105 mg) after an overnight fast of ≥10.5 hours.
Data highlights include:
- Bioavailability of minocycline was significantly lower after a single dose of DFD-29 under fasting and fed conditions vs. Solodyn (105 mg) following a single dose under fasting conditions.
- Food intake had no impact on maximum concentration (Cmax) of minocycline from DFD-29 but may delay absorption and may slightly increase exposure (AUC).
- Treatment-emergent adverse events were mostly mild (21/22; 95.5%), the most common being headache. No serious adverse events were reported in the study.
Claude Maraoui, Co-Founder, President and Chief Executive Officer of Journey Medical, stated, “We continue to be encouraged by the growing body of clinical research evaluating DFD-29. Given the previously reported positive results from our two Phase 3 clinical trials of DFD-29, we anticipate submitting a New Drug Application to the FDA by the end of this year. If approved, DFD-29 will be the lowest-dose minocycline on the market and may create a paradigm shift in how rosacea is treated in the millions of patients suffering from this condition.”
