Journey Medical Reports Positive Phase 1 Results for Emrosi Rosacea Treatment, Showing No Impact on Microbiome

Journey Medical Corporation查看公司主页 has announced the publication of positive Phase 1 clinical trial results for Emrosi (搜索)搜索该药品 (40 mg minocycline查看药品详情 hydrochloride modified-release capsules) in the Journal of Drugs in Dermatology, demonstrating that the FDA-approved rosacea (搜索)搜索该疾病 treatment can be safely used for up to 16 weeks without impacting the body's natural microbiome.

The multicenter, randomized, double-blind, placebo-controlled study (DFD-29查看药品详情-CD-006) enrolled 60 healthy adult subjects in a 2:1 randomization between DFD-29 (the investigational name for Emrosi (搜索)搜索该药品) and placebo. Treatment was administered once daily orally over 16 weeks, with microbiological samples collected from the skin (forehead), stool, and vagina at multiple timepoints throughout the study.

Study Achieves All Primary Endpoints

The clinical trial successfully met all three primary microbiological objectives:

1. No significant change in the normal microbiome of the skin, vagina, or gastrointestinal tract
2. No noticeable development of antibiotic resistance to minocycline
3. No significant emergence of opportunistic organisms compared to treatment with placebo

"We are very pleased to see these important data published in the Journal of Drugs in Dermatology," said Claude Maraoui, Co-Founder, President and Chief Executive Officer of Journey Medical. "This peer-reviewed validation reinforces the differentiated profile of Emrosi (搜索)搜索该药品 as an effective, low-dose oral treatment for rosacea (搜索)搜索该疾病 that does not meaningfully disrupt the normal microbiota or contribute to antibiotic resistance."

Addressing Significant Unmet Medical Need

Rosacea (搜索)搜索该疾病 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, the condition affects over 16 million Americans and as many as 415 million people worldwide, most frequently seen in adults between 30 and 50 years of age.

The disease carries substantial psychosocial burden. Surveys conducted by The National Rosacea (搜索)搜索该疾病 Society report that more than 90 percent of rosacea patients said their condition had lowered their self-confidence and self-esteem, and 41 percent stated 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.

Safety Profile and Clinical Implications

There were no significant safety issues noted during the 16-week study period. The most common adverse reaction reported by ≥1% of subjects treated with Emrosi (搜索)搜索该药品 and more frequently than in subjects receiving placebo was dyspepsia.

Emrosi (搜索)搜索该药品 is formulated as a modified-release capsule containing 10 mg immediate release and 30 mg extended release minocycline查看药品详情 hydrochloride, and is indicated for the treatment of inflammatory lesions (papules and pustules) of rosacea (搜索)搜索该疾病 in adults.

The results support Emrosi (搜索)搜索该药品's potential for long-term use and underscore Journey Medical's commitment to bringing safe, innovative dermatology treatments to patients. Additional information on the DFD-29查看药品详情 Phase 1 clinical trial can be found on ClinicalTrials.gov using the identifier NCT05597462查看临床试验.

Journey Medical Corporation查看公司主页 is a commercial-stage pharmaceutical company that primarily focuses on selling and marketing FDA-approved prescription pharmaceutical products for the treatment of dermatological conditions. The company currently markets eight branded FDA-approved prescription drugs that help treat and heal common skin conditions.