Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”), a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of FDA-approved prescription pharmaceutical products for the treatment of dermatological conditions, today announced that it expects topline results from the two Phase 3 multicenter, randomized, double-blind, parallel-group, active-comparator and placebo-controlled clinical trials, MVOR-1 (Minocycline versus Oracea® in Rosacea-1) and MVOR-2 (Minocycline versus Oracea in Rosacea-2), evaluating DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) for the treatment of moderate to severe papulopustular rosacea (“PPR”), to be announced the week of July 10, 2023. DFD-29 is being developed for the treatment of PPR in collaboration with Dr. Reddy’s Laboratories Ltd.
The DFD-29 Phase 3 clinical program consists of two multicenter, randomized, double-blind, parallel-group, active-comparator and placebo-controlled clinical trials, MVOR-1 (Minocycline versus Oracea in Rosacea-1) and MVOR-2 (Minocycline versus Oracea in Rosacea-2), that are expected to support a New Drug Application (“NDA”) submission in the United States and 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 enrolled patients in the United States, and the other enrolled patients in both the United States and Europe. The MVOR-1 and MVOR-2 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).
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