Journey Medical Corporation Announces DFD-29 Data at 44th Fall Clinical Dermatology Conference

Journey Medical Corporation recently unveiled data at the 44th Fall Clinical Dermatology Conference in Las Vegas, Nevada, comparing the dermal and systemic pharmacokinetics (PK) of their new modified-release oral minocycline product, DFD-29, with oral doxycycline (Oracea®). This study involved healthy adult participants and aimed to evaluate the potential of DFD-29 in treating rosacea.

DFD-29, a 40 mg modified-release formulation of minocycline hydrochloride, was administered once daily for 21 days. The comparative study also included a similar daily dose of oral doxycycline 40 mg capsules. The PK parameters measured included the maximum concentration (Cmax) and the area under the curve (AUC) in both plasma and dermal tissues.

The results illustrated that DFD-29 maintained higher dermal concentrations of minocycline from Day 1 through Day 21 compared to doxycycline, which showed lower initial concentrations that peaked later in the study. Furthermore, while the plasma levels of minocycline remained stable from Day 1 to Day 21, doxycycline demonstrated a significant accumulation in plasma during the same period. Both medications were well tolerated by the study participants, indicating their safety for human use.

Srinivas Sidgiddi, M.D., Vice President of Research & Development at Journey Medical, highlighted that the modified-release formulation of DFD-29 is designed to provide higher dermal concentrations more quickly and consistently than doxycycline. This characteristic could lead to more effective treatment outcomes for patients suffering from rosacea, a chronic skin condition characterized by redness, inflammation, and acne-like lesions.

Rosacea affects a sizable portion of the population, with estimates suggesting over 16 million Americans and 415 million people worldwide are affected. The condition often impacts adults between 30 and 50 years old and can significantly lower self-esteem and disrupt social and professional lives. Many patients report avoiding social engagements and experiencing difficulties at work due to the visible symptoms of rosacea.

Journey Medical Corporation, headquartered in Scottsdale, Arizona, specializes in the commercialization of dermatology-focused prescription pharmaceutical products. The company markets nine products, including seven branded and two generic medications, designed to treat common skin conditions. Founded by Fortress Biotech, Inc., Journey Medical leverages an experienced team with a robust background in the dermatology sector.

The CEO of Journey Medical, Claude Maraoui, emphasized the potential of DFD-29 to transform rosacea treatment based on the safety and efficacy data from clinical trials. The company has submitted a New Drug Application (NDA) for DFD-29 to the U.S. Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) goal date set for November 4, 2024. If approved, DFD-29 could become the lowest fixed-dose minocycline option and a leading treatment choice for rosacea patients.

Overall, the promising PK profile of DFD-29 positions it as a potentially superior therapy for rosacea, with the potential to improve patient outcomes significantly. Journey Medical continues to advance its mission of delivering effective dermatological treatments, driven by innovation and a commitment to addressing unmet medical needs in the field of dermatology.