The Phase 3 clinical trials are part of a collaboration with Dr. Reddy’s Laboratories Ltd. for the ongoing development and commercialization of the DFD-29 (Minocycline Modified Release Capsules 40 mg) program.

Journey Medical Corporation’s Phase 3 clinical trial program of DFD-29 for papulopustular rosacea is now fully enrolled.

The Phase 3 clinical trials are part of a collaboration with Dr. Reddy’s Laboratories Ltd. for the ongoing development and commercialization of the DFD-29 (Minocycline Modified Release Capsules 40 mg) program.

 “We are thrilled to have completed enrollment in our two DFD-29 Phase 3 clinical trials and look forward to announcing topline data in the first half of 2023, with a New Drug Application (“NDA”) filing subsequently expected in the second half of 2023,” says Claude Maraoui, Co-Founder, President and Chief Executive Officer of Journey Medical, in a press release. “We are extremely grateful to the patients, physicians and their research teams participating in these clinical trials, as they are essential to the development of a new treatment option for the millions of patients worldwide who suffer with rosacea. Data from the Phase 2 multicenter clinical trial demonstrated that DFD-29 achieved nearly double the efficacy compared to doxycycline capsules 40 mg on reducing total inflammatory lesions and Investigator’s Global Assessment (“IGA”) treatment success, suggesting the potential of DFD-29 as a more effective treatment option for rosacea. After approval, we anticipate DFD-29 achieving peak annual net sales exceeding $100 million.”

The DFD-29 Phase 3 clinical program consists of two multicenter, randomized, double-blind, parallel-group, active-comparator, and placebo-controlled clinical trials, MVOR-01 and MVOR-02 (Minocycline versus Oracea in Rosacea), that are expected to support an NDA submission in the United States and potentially a Marketing Authorization Application in Europe. The combined enrollment target of 640 total adult patients with moderate to severe PPR was achieved in the trials; one trial was enrolling patients in the United States, and the other was enrolling patients in both the United States and Europe. The MVOR-01 and MVOR-02 clinical trials are randomized in a 3:3:2 ratio to DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg), Oracea (Doxycycline capsules 40 mg) or placebo once daily for 16 weeks. The primary objective is to evaluate the safety, efficacy and tolerability of DFD-29 compared to placebo for the treatment of PPR. The secondary objective is to evaluate the safety, efficacy and tolerability of DFD-29 compared to Oracea (Doxycycline capsules 40 mg). To date, no major safety issues have been reported, and no drug-related serious adverse events have been observed.

Data published in The Journal of Clinical and Aesthetic Dermatology determined DFD-29 40 mg demonstrated significantly greater efficacy than doxycycline 40 mg, placebo and DFD-29 20 mg for the treatment of PPR in a Phase 2 clinical study. DFD-29 40 mg demonstrated statistical significance compared to both placebo and doxycycline 40 mg on both co-primary endpoints—proportion of subjects with IGA treatment success (grade 0 or 1 with at least a two-grade reduction from baseline at week 16) and total inflammatory lesion count reduction from baseline to week 16.

"Despite how common rosacea is, and effective treatment is still an unmet need for so many patients," says Joshua Zeichner, MD Director of Cosmetic and Clinical Research in the department of dermatology at The Mount Sinai Hospital in New York City. "This new oral medication will bring an additional option for patients not adequately controlled with the currently available treatments. Minocycline is traditionally thought of as an acne treatment, but there’s mounting data supporting is used for rosacea as well. "

Additional information on the DFD-29 Phase 3 clinical trial program can be found on ClinicalTrials.gov using the identifiers: NCT05296629 and NCT05343455.