DFD-29 Shows No Major impact on Healthy Microbial Flora in Rosacea

June 15, 2023

DFD-29 is being developed for the treatment of papulopustular rosacea by Journey Medical Corporation with Dr. Reddy’s Laboratories Ltd.

DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) doesn’t disrupt the microbial floral in healthy adults with papulopustular rosacea, according to data from a Phase 1 clinical trial.

DFD-29 is being developed for the treatment of papulopustular rosacea by Journey Medical Corporation with Dr. Reddy’s Laboratories Ltd.

The clinical trial also assessed the safety and tolerability of the treatment and found that DFD-29 can be safely used for up to 16 weeks with no significant risk of microbiota suppression or development of resistance

DFD-29-CD-006 is a multi-center, randomized, double-blind, placebo-controlled, parallel group study that enrolled 60 healthy, adult subjects (30 males and 30 females) in a 2:1 randomization between DFD-29 and placebo. Treatment was administered once daily orally over 16 weeks. 

Microbiological samples were collected from the skin (forehead), stool and vagina at multiple timepoints through the study. The study achieved all primary objectives and no significant safety issues were noted during the study. Treatment with DFD-29 for 16 weeks did not produce significant negative impact on the normal microbial flora and did not induce significant bacterial resistance. Additionally, treatment with DFD-29 did not cause significant proliferation of opportunistic organisms. The results indicate that DFD-29 can be safely used for up to 16 weeks with no significant risk of microbiota suppression or development of resistance. 

 “We are very pleased with the topline results of this Phase 1 clinical trial, indicating that DFD-29 can be safely used for up to 16 weeks with no significant risk of microbiota suppression or development of resistance.,” says Claude Maraoui, Co-Founder, President and Chief Executive Officer of Journey Medical, in a news release. “Additionally, we anticipate topline data from the Phase 3 clinical trials in June, with a New Drug Application filing subsequently expected in the second half of 2023. If approved, DFD-29 could provide a new treatment option for the millions of patients suffering from rosacea.”

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 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 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.

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