Positive topline results show DFD-29 superior in treatment of rosacea
Key takeaways:
- Both phase 3 trials met all primary and secondary endpoints.
- Based on these results, the company plans on submitting a new drug application for DFD-29 in the second half of 2023.
Two phase 3 clinical trials evaluating DFD-29 for the treatment of adults with papulopustular rosacea achieved positive topline results, according to a Journey Medical Corporation press release.
According to Claude Maraoui, president and CEO of Journey Medical Corporation, the results showed statistical superiority over Oracea (doxycycline, Galderma) and placebo.
“This is a significant milestone for Journey Medical and potentially the broader dermatology community,” Maraoui told Healio.
DFD-29 is a 40 mg minocycline hydrochloride modified release capsule that is currently being developed by Journey in collaboration with Dr. Reddy’s Laboratories Ltd. for the treatment of papulopustular rosacea.
Following recently released phase 1 results, these two multicenter, randomized, double-blind, phase 3 studies — MVOR-1 and MVOR-2 — compared DFD-29 with doxycycline and placebo for the treatment of papulopustular rosacea.
Patients were randomly assigned 3:3:2 to receive once-daily DFD-29, doxycycline 40 mg or placebo orally for 16 weeks. Results showed that both trials met all primary and secondary endpoints.
In MVOR-1, 65% of the DFD-29 group demonstrated IGA success compared with 46.1% of the doxycycline group (P = .007) and 31.2% of the placebo group (P < .001). Patients treated with DFD-29 experienced a mean reduction of 21.3 lesions, whereas patients in the doxycycline and placebo groups experienced a mean reduction of 15.9 and 12.2 lesions, respectively (P < .001 for both).
Similarly, in MVOR-2, 60.1% of the DFD-29 groups achieved IGA success compared with 31.4% of the doxycycline group and 26.8% of the placebo group (P < .001 for both). The mean reduction of lesions was also significantly higher in the DFD-29 group (18.4) compared with the doxycycline (14.9) and placebo (11.1) groups (P < .001 for both).
“Based on these positive study results, we plan on submitting a new drug application for DFD-29 in the second half of 2023,” Maraoui said.