Enrollment complete in DFD-29 phase 3 trials for papulopustular rosacea

Journey Medical Corporation announced that it has completed enrollment in its phase 3 clinical program evaluating the safety and efficacy of DFD-29 for the treatment of papulopustular rosacea, according to a company press release.

The program, in collaboration with Dr. Reddy’s Laboratories Ltd., consists of two multicenter, randomized, double-blind, parallel-group, active-comparator and placebo-controlled clinical trials, MVOR-01 and MVOR-02.

“There have been no serious adverse reactions in the two studies thus far,” Srinivas Sidgiddi, MD, vice president of clinical development and medical affairs at Journey Medical Corporation, told Healio. “The feedback from investigators has been that their patients are generally happy with the study treatment.”

Combined, the studies have enrolled 640 adult patients with moderate to severe papulopustular rosacea (PPR) in both the U.S. and Europe. Patients were randomly assigned 3:3:2 to DFD-29 (minocycline modified release capsules 40 mg), Oracea (doxycycline capsules 40 mg, USP) or placebo.

Primary and secondary objectives include evaluating the drug’s safety, efficacy and tolerability to placebo and doxycycline 40 mg, respectively. Results from the phase 2 trial demonstrated significantly greater efficacy of DFD-29 40 mg compared with placebo, doxycycline 40 mg and DFD-29 20 mg.

According to the release, Journey Medical expects the program data to support a new drug application submission in the United States in the second half of 2023, as well as a potential marketing authorization application in Europe.