Journey Medical Publishes Full Phase 3 Trial Results for DFD-29

Full results of the MVOR-1 (NCT05296629) and MVOR-2 (NCT05343455) phase 3 clinical trials have been published by Journey Medical Corporation for its minocycline hydrochloride, 40 mg extended release capsules (DFD-29/Emrosi) in the treatment of rosacea.¹ The findings, which were published in the Journal of the American Medical Association - Dermatology showed the oral treatment’s efficacy, safety, and tolerability for adults with moderate-to-severe papulopustular rosacea.

After 16 weeks of once-daily treatment, the therapy reached its co-primary and all secondary endpoints with no safety issues. Lesion and erythema reduction was statistically significant when compared to doxycycline capsules (40 mg) and placebo, according to the Investigator’s Global Assessment (IGA) and Clinician’s Erythema Assessment (CEA) scales. Adult participants (n = 653) in both multicenter, double-blind trials in the US and Germany were randomized 3:3:2 to receive either DFD-29, doxycycline, or placebo between March 2022 and May 2023.

In the MVOR-1 trial, 65.0% of patients taking DFD-29 saw IGA success, compared to 46.1% in the doxycycline group and 31.2% in the placebo cohort. The DFD-29 group showed a mean reduction of 21.3 lesions, while the doxycycline group had a reduction of 15.8 lesions, and the placebo group demonstrated a reduction of 12.1 lesions. Furthermore, after 16 weeks, a greater percentage of DFD-29 patients experienced at least a 2-grade reduction from baseline in CEA score compared to placebo (31.7% vs 13.8%).

In the MVOR-2 trial, 60.1% of patients taking DFD-29 saw IGA success, compared to 31.4% in the doxycycline group and 26.8% in the placebo cohort. The DFD-29 group showed a mean reduction of 18 lesions, while the doxycycline group had a reduction of 14.9 lesions, and the placebo group demonstrated a reduction of 11.1 lesions. Additionally, more DFD-29 patients experienced at least a 2-grade reduction after 16 weeks in CEA score compared to placebo (24.5% vs 12.0%).

Regarding the safety profile, there were no serious adverse effects in either trial. Any treatment-emergent adverse events were minor and remained similar between all the groups. The most common adverse effect reported was nasopharyngitis.

DFD-29 was approved by the FDA in November 2024 and is planned to launch this spring, making it the only oral, systemic therapy approved to address both erythema and inflammatory lesions associated with rosacea.²

The co-founder, president, and Chief Executive Officer of Journey Medical, Claude Maraoui, said in a statement, “Emrosi’s FDA approval last November, supported by these robust and clinically meaningful outcomes, positions it as a potential new treatment paradigm for millions of patients with rosacea. We are thrilled that the positive results of our two Phase 3 clinical trials were published in JAMA Dermatology. This milestone underscores the significance of these findings and reinforces Emrosi’s potential to meaningfully benefit patients when we launch, which we expect will be in early spring.”¹

References

1. Journey Medical Corporation Announces Publication in the Journal of the American Medical Association - Dermatology of the Phase 3 Clinical Trial Results of Emrosi™ (DFD-29) to Treat Rosacea. News release. March 5, 2025. Accessed March 6, 2025. https://ir.journeymedicalcorp.com/new-events/press-releases/detail/79/journey-medical-corporation-announces-publication-in-the

2. Journey Medical Corporation. Journey Medical Corporation Announces U.S. FDA Approval of Emrosi™ (Minocycline Hydrochloride Extended Release Capsules, 40 mg) for the Treatment of Rosacea. GlobeNewswire News Room. November 4, 2024. Accessed March 6, 2025. https://www.globenewswire.com/news-release/2024/11/04/2973917/0/en/Journey-Medical-Corporation-Announces-U-S-FDA-Approval-of-Emrosi-Minocycline-Hydrochloride-Extended-Release-Capsules-40-mg-for-the-Treatment-of-Rosacea.html