DFD-29 rosacea treatment shows no significant impact on healthy, microbial flora

Key takeaways:

• DFD-29 induced no significant changes in the microbial floral of healthy adults and can be safely used for 16 weeks.
• Phase 3 results for DFD-29 in the treatment of rosacea will be announced later this month.

Journey Medical Corporation announced positive, topline results from its phase 1 clinical trial evaluating the impact of DFD-29 on the microbial flora of healthy adults, according to a company press release.

“We are very pleased with the topline results of this Phase 1 clinical trial, indicating that DFD-29 can be safely used for up to 16 weeks with no significant risk of microbiota suppression or development of resistance” Claude Maraoui, president and CEO of Journey Medical Corporation, told Healio.

DFD-29 is a 40 mg minocycline hydrochloride modified release capsule that is currently being developed for the treatment of papulopustular rosacea.

Claude Maraoui

In this multicenter, randomized, double-blind, phase 1 study, DFD-29 was assessed for its effects on the microbial floral of 60 healthy individuals compared with placebo.

Patients were randomly assigned in a 2:1 ratio to receive once-daily DFD-29 or placebo orally for 16 weeks. Researchers collected microbiological samples from the skin of the forehead, stool and vagina at multiple timepoints in the study.

Results showed that all primary objectives were met including no significant change in the number of colony-forming units of microbial species or changes in MIC90 of selected colonized microbial species in patients treated with DFD-29 compared with placebo.

Additionally, DFD-29 treatment did not cause significant proliferation of opportunistic organisms, negative impact on normal microbial floral or bacterial resistance over the course of 16 weeks, according to the release.

These results bode well for DFD-29 which has recently undergone phase 3 trials for the treatment of papulopustular rosacea.

“We anticipate topline data from the Phase 3 clinical trials in June, with a New Drug Application filing subsequently expected in the second half of 2023,” Maraoui said.

Reference

• Impact of DFD-29 on Microbial Flora of Healthy, Adult Human Subjects When Administered Over 16 Weeks. Updated Nov. 8, 2022. Accessed June 13, 2023. https://clinicaltrials.gov/ct2/show/NCT05597462.