Journey Medical's DFD-29 (minocycline hydrochloride modified release capsules) has shown statistically significant superiority over both Oracea (doxycycline) and placebo in treating moderate-to-severe papulopustular rosacea in adults. The positive topline results come from two Phase 3 clinical trials, MVOR-1 and MVOR-2, potentially paving the way for a new treatment paradigm for millions affected by rosacea.
Phase 3 Trial Results
The MVOR-1 and MVOR-2 trials randomized subjects in a 3:3:2 ratio to receive DFD-29, Oracea (40 mg doxycycline), or placebo once daily for 16 weeks. The primary objective was to evaluate the safety and efficacy of DFD-29 compared to placebo, while the secondary objective assessed its efficacy compared to Oracea. Both trials successfully achieved the co-primary and all secondary endpoints.
In MVOR-1, 65% of subjects in the DFD-29 group achieved Investigator's Global Assessment (IGA) success, compared to 46.1% in the Oracea group (p=0.007) and 31.2% in the placebo group (p<0.001). The DFD-29 group also demonstrated a mean reduction of 21.3 lesions from baseline to week 16, significantly greater than the 15.9 lesions in the Oracea group and 12.2 lesions in the placebo group (p<0.001 for both comparisons).
Similarly, MVOR-2 showed that 60.1% of subjects in the DFD-29 group achieved IGA success, compared to 31.4% in the Oracea group (p<0.001) and 26.8% in the placebo group (p<0.001). The mean lesion reduction from baseline to week 16 was 18.4 in the DFD-29 group, 14.9 in the Oracea group, and 11.1 in the placebo group (p<0.001 for both comparisons).
Safety Profile
Both trials reported no major safety issues and no serious adverse events related to the study products. The number and severity of treatment-emergent adverse events (TEAEs) were similar across all treatment groups, including those related to the study products.
Implications for Rosacea Treatment
"We are very pleased with the positive results for our two Phase 3 clinical trials evaluating DFD-29 for the treatment of rosacea, which demonstrated statistical superiority over both Oracea and placebo," said Claude Maraoui, Co-Founder, President, and Chief Executive Officer of Journey Medical. "With these clinically meaningful outcomes, DFD-29 has the potential to be the new treatment paradigm for the millions of patients suffering from rosacea as the lowest-dose oral minocycline on the market."
Journey Medical anticipates submitting a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for DFD-29 in the second half of 2023.
