Journey Medical Corporation Announces Positive Topline Data from Phase 1 Clinical Trial Assessing the Impact of DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) on Microbial Flora of Healthy Adult Subjects - Seite 2

Claude Maraoui, Co-Founder, President and Chief Executive Officer of Journey Medical, stated, “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. 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 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). To date, no major safety issues have been reported, and no drug-related serious adverse events have been observed.

About Rosacea
Rosacea is a chronic, relapsing, inflammatory skin condition that most commonly presents with symptoms such as deep facial redness, acne-like inflammatory lesions (papules and pustules) and spider veins (telangiectasia). According to The National Rosacea Society, it is estimated that rosacea affects well over 16 million Americans and as many as 415 million worldwide. Rosacea is most frequently seen in adults between 30 and 50 years of age. Surveys conducted by The National Rosacea Society report more than 90 percent of rosacea patients said their condition had lowered their self-confidence and self-esteem, and 41 percent reported that it had caused them to avoid public contact or cancel social engagements. Among rosacea patients with severe symptoms, 88 percent said the disorder had adversely affected their professional interactions, and 51 percent said they had missed work because of their condition.