Journey Medical Corp. announced that it has fully enrolled and randomized all of the patients in its Phase 3 clinical program to assess the safety, efficacy and tolerability of DFD-29 (minocycline modified release capsules 40 mg) for the treatment of papulopustular rosacea, the company announced in a news release. 

The Phase 3 clinical trials are part of a collaboration with Dr. Reddy’s Laboratories for the ongoing development and commercialization of the DFD-29 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 filing subsequently expected in the second half of 2023," Claude Maraoui, Co-Founder, President, and Chief Executive Officer of Journey Medical, said in the news release.

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 papulopustular rosacea. 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 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," Mr. Maraoui said.