Journey Medical Reports Positive Results From Phase 3 Trials With DFD-29; Plans NDA In H2

(RTTNews) - Journey Medical Corp. (DERM) reported positive topline results from the two Phase 3 double-blind, parallel-group, active-comparator and placebo-controlled clinical trials, Minocycline Versus Oracea in Rosacea-1 or MVOR-1 and Minocycline Versus Oracea in Rosacea-2 or MVOR-2, evaluating Minocycline Hydrochloride Modified Release Capsules, 40 mg for the treatment of moderate-to-severe papulopustular rosacea in adults. The trials achieved the co-primary and all secondary endpoints and subjects completed the 16-week treatment with no significant safety issues, the company said. DFD-29 showed statistical superiority over both Oracea capsules and placebo for Investigator's Global Assessment treatment success in both studies.

Based on these results, the company plans on submitting a new drug application for DFD-29 in the second half of 2023. If approved by the FDA, the company believes that DFD-29 has annual peak sales potential of $300 million, globally.

Minocycline Hydrochloride Modified Release Capsules or DFD-29 is being developed for the treatment of rosacea in collaboration with Dr. Reddy's. The DFD-29 Phase 3 program is expected to support an NDA submission in the U.S. and a Marketing Authorization Application in Europe.

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