Based on these results, Journey Medical plans to submit an NDA to the FDA for DFD-29 in the second half of 2023.

Minocycline Hydrochloride Modified Release Capsules (DFD-29) outperformed Oracea (doxycycline) capsules and placebo for the treatment of moderate-to-severe papulopustular rosacea in adults, according to positive topline results from two Phase 3 studies.

Journey Medical’s DFD-29 is being developed for the treatment of rosacea in collaboration with Dr. Reddy’s Laboratories Ltd. Based on these positive study results, Journey plans to submit a new drug application to the US Food and Drug Administration for DFD-29 in the second half of 2023.

Subjects in the Minocycline Versus Oracea in Rosacea-1 (MVOR-1) and Minocycline Versus Oracea in Rosacea-2 (MVOR-2) Phase 3 clinical trials were randomized in a 3:3:2 ratio to treatment with DFD-29, Doxycycline Capsules, 40 mg (Oracea) or placebo once daily for 16 weeks. The primary objective of both studies was to evaluate the safety and efficacy of DFD-29 compared to placebo for the treatment of papulopustular rosacea. The secondary objective was to evaluate the safety and efficacy of DFD-29 compared to Oracea. Both clinical trials achieved the co-primary and all secondary endpoints, which compared the efficacy of DFD-29 to Oracea and placebo for the treatment of rosacea. The proportion of subjects achieving Investigator’s Global Assessment (IGA) treatment success in the DFD-29 group was statistically superior to those in Oracea and placebo groups. 

Additionally, the reduction in the total inflammatory lesion count from baseline to week 16 in the DFD-29 group was statistically superior to Oracea and placebo groups. 

There were no major safety issues and no serious adverse events related to study products in both MVOR-1 and MVOR-2 trials. The number of treatment-emergent adverse events (TEAEs) and their severity were similar between the treatment groups. The number of TEAEs related to study products were also similar between the groups.

MVOR-1 Topline Results

In the DFD-29 group, 65% of subjects demonstrated IGA success, while 46.1% showed IGA success in the Oracea group and 31.2% of subjects showed IGA success in the placebo group. The difference between the DFD-29 and Oracea groups was statistically significant with a p-value of 0.007, and the difference between the DFD-29 and the placebo groups was statistically significant with a p-value of <0.001. The DFD-29 group showed a mean reduction of 21.3 lesions, while the Oracea group showed a mean reduction of 15.9 lesions, and the placebo group showed a mean reduction of 12.2 lesions from baseline to week 16. The difference between the DFD-29 and Oracea groups and the difference between the DFD-29 and placebo groups were statistically significant, each with a p-value of <0.001.

MVOR-2 Topline Results

In the DFD-29 group, 60.1% of subjects demonstrated IGA success, while 31.4% showed IGA success in the Oracea group and 26.8% of subjects showed IGA success in the placebo group. The difference between the DFD-29 and Oracea groups was statistically significant with a p-value of <0.001, and the difference between the DFD-29 and the placebo groups was statistically significant with a p-value of <0.001. The DFD-29 group showed a mean reduction of 18.4 lesions, while the Oracea group showed a mean reduction of 14.9 lesions, and the placebo group showed a mean reduction of 11.1 lesions from baseline to week 16. The difference between the DFD-29 and Oracea groups and the difference between the DFD-29 and placebo groups were statistically significant, each with a p-value of <0.001.

 “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,” says Claude Maraoui, Co-Founder, President, and Chief Executive Officer of Journey Medical, in a news release. “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.”