Journey Medical initiates rosacea drug trial
Journey Medical Corporation has begun the first of two phase 3 trials evaluating DFD-29 for the treatment of papulopustular rosacea, the company announced in a press release.
The first of up to 340 patients has received DFD-29 — minocycline modified release capsules 40 mg — in a multicenter, randomized, double-blind, parallel-group trial. There will be both an active and placebo-controlled trial.
In the studies, participants will be randomly assigned 3:3:2 to receive DFD-29, doxycycline capsules 40 mg (Oracea, USP) or placebo for 16 weeks.
“Reaching this milestone marks another important inflection point for Journey Medical. We began as a commercial-stage pharmaceutical company and have evolved into a fully integrated pharmaceutical company with a research and development division that has the capability to expand available dermatologic treatment options,” Claude Maraoui, cofounder, president and CEO of Journey Medical Corporation, said in the release. “Research to date demonstrates the potential of DFD-29 as a more effective treatment option that we hope to provide for the millions of patients worldwide that suffer with rosacea.”
The two trials, which will study the safety, efficacy and tolerability of DFD-29, are a collaboration with Dr. Reddy’s Laboratories for the development and commercialization of the drug.