Pharma Focus Europe

Journey Medical Corporation to Reveal Phase 3 Trial Findings for DFD-29 in Papulopustular Rosacea Treatment Around July 10, 2023

Tuesday, July 04, 2023

Journey Medical Corporation (Nasdaq: DERM) has made an announcement regarding the upcoming release of the topline results for its Phase 3 clinical trials of DFD-29, a potential treatment for moderate to severe papulopustular rosacea (PPR). The trials, known as MVOR-1 and MVOR-2, are double-blind, multicenter studies that compare DFD-29 with Oracea® and a placebo. The company expects to disclose the results during the week of July 10, 2023. Journey Medical has partnered with Dr. Reddy's Laboratories Ltd. in the development of DFD-29 for PPR treatment.

The Phase 3 program for DFD-29 consists of two trials involving a total of 640 adult patients diagnosed with moderate to severe PPR. One trial enrolled participants from the United States, while the other included patients from both the United States and Europe. The trials utilized a random assignment ratio of 3:3:2, with patients receiving DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg), Oracea (Doxycycline Capsules, 40 mg), or a placebo once daily for 16 weeks. The primary objective of the trials is to assess the safety, efficacy, and tolerability of DFD-29 compared to the placebo for PPR treatment. The secondary objective is to evaluate the safety, efficacy, and tolerability of DFD-29 compared to Oracea.

Rosacea is a chronic inflammatory skin condition characterized by symptoms such as facial redness, papules, pustules, and telangiectasia. It affects a substantial number of individuals worldwide, with over 16 million Americans and an estimated 415 million people globally suffering from rosacea. The condition is most commonly seen in adults aged 30 to 50 years. Rosacea can have significant negative impacts on self-confidence, self-esteem, and social interactions, leading to reduced public contact and work absences. Oracea® is a registered trademark of Galderma Holdings, S.A.

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