Journey Medical Corporation Announces Presentation of Data from Phase 1 Clinical Trial Assessing the Impact of DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) on Microbial Flora of Healthy Adults at 2024 AAD Annual Meeting
12 Mar 2024
Clinical Result
Clinical trial achieved all three primary objectives and subjects completed 16-week treatment with no significant safety issues
Results indicate that DFD-29 can be safely used for up to 16 weeks with no detectable effects on microbiota in the skin, GI tract, or vagina
New Drug Application for DFD-29 currently under review by U.S. FDA
March 11, 2024 --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, announces that data from the Phase 1 clinical trial (DFD-29-CD-006) assessing the impact of DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) on the microbial flora of healthy adults were presented at the 2024 American Academy of Dermatology (AAD) Annual Meeting that took place March 8-12, 2024, in San Diego, CA. The clinical trial also assessed the safety and tolerability of the treatment. The data were presented by Srinivas Sidgiddi, M.D., Vice President, Research & Development of Journey Medical. DFD-29 is being developed for the treatment of rosacea in collaboration with Dr. Reddy’s Laboratories Ltd.
Claude Maraoui, Co-Founder, President, and Chief Executive Officer of Journey Medical, stated, “We are encouraged by the data presented at the AAD meeting as they demonstrate that DFD-29 can be safely used for up to 16 weeks with no significant risk of microbiota suppression or development of resistance. Based on the robust safety and efficacy data seen throughout all of our clinical trials, we believe that DFD-29 has the potential to change the treatment landscape for the millions of patients suffering from rosacea. If approved, DFD-29 has potential to be best-in-class and the only oral medication to address both inflammatory lesions and erythema (redness) from rosacea.”
DFD-29-CD-006 is a multicenter, 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. Additional information on the DFD-29 Phase 1 clinical trial can be found on ClinicalTrials.gov using the identifier NCT05597462.
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.
About Journey Medical Corporation
Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”) is 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 through its efficient sales and marketing model. The company currently markets seven branded and two generic products that help treat and heal common skin conditions. The Journey Medical team comprises industry experts with extensive experience in developing and commercializing some of dermatology’s most successful prescription brands. Journey Medical is located in Scottsdale, Arizona and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). Journey Medical’s common stock is registered under the Securities Exchange Act of 1934, as amended, and it files periodic reports with the U.S. Securities and Exchange Commission (“SEC”). For additional information about Journey Medical, visit www.journeymedicalcorp.com.
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