Journey Medical Touts Positive PK Data For Bacterial Infection Candidate

Journey Medical Corporation DERM announced PK comparability data of DFD-29 and key updates on the progress of its pivotal, Phase 3 study of DFD-29 for papulopustular rosacea in collaboration with Dr. Reddy's Laboratories Ltd RDY.
Papulopustular rosacea is associated with "whitehead" pustules, pus-filled blemishes, and red, swollen bumps.
The PK study was designed as a comparative bioavailability study of DFD-29 (Minocycline Modified Release Capsules 40 mg) versus Solodyn (Minocycline Modified Release Tablets 105 mg).
Minocycline is a prescription medicine used to treat the symptoms of many different bacterial infections.
A total of 24 healthy adult volunteers were enrolled and examined for up to 30 days.
The study successfully demonstrated that the systemic exposure of DFD-29 (40 mg) was significantly lower than that of SOLODYN (105 mg).
Additionally, the study showed that food did not significantly affect the pharmacokinetics of DFD-29.
Claude Maraoui, Co-Founder, President & CEO of Journey Medical, stated, "the PK data indicate the safety of DFD-29 is on par with Solodyn.
The company looks forward to providing further updates on the DFD-29 program, including potential topline data from the Phase 3 studies anticipated in the first half of 2023.
Journey Medical also plans to file a New Drug Application in the second half of 2023.
Price Action: DERM shares are down 9.23% at $1.18 on the last check Tuesday.