Topline results from the phase III MVOR-1 and MVOR-2 trials comparing DFD 29 against Galderma’s Oracea in papulopustular rosacea
Journey Medical Corporation announced positive topline results from the two Phase III multicenter, randomized, double-blind, parallel-group, active-comparator and placebo-controlled clinical trials, Minocycline Versus Oracea in Rosacea-1 (“MVOR-1”) and Minocycline Versus Oracea in Rosacea-2 (“MVOR-2”), evaluating Minocycline Hydrochloride Modified Release Capsules, 40 mg (“DFD 29”) for the treatment of moderate-to-severe papulopustular rosacea in adults
DFD 29 is being developed for the treatment of rosacea in collaboration with Dr. Reddy’s Laboratories Ltd.
Subjects in the MVOR-1 and MVOR-2 Phase III clinical trials were randomized in a 3:3:2 ratio to treatment with DFD 29, Doxycycline Capsules, 40 mg (“Oracea”) or placebo once daily for 16 weeks. The primary objective of both studies was to evaluate the safety and efficacy of DFD 29 compared to placebo for the treatment of papulopustular rosacea. The secondary objective was to evaluate the safety and efficacy of DFD 29 compared to Oracea. Both clinical trials achieved the co-primary and all secondary endpoints, which compared the efficacy of DFD 29 to Oracea and placebo for the treatment of rosacea.
The proportion of subjects achieving Investigator’s Global Assessment (“IGA”) treatment success in the DFD 29 group was statistically superior to those in Oracea and placebo groups. Additionally, the reduction in the total inflammatory lesion count from baseline to week 16 in the DFD 29 group was statistically superior to Oracea and placebo groups. There were no major safety issues and no serious adverse events related to study products in both MVOR-1 and MVOR-2 trials.
The number of treatment emergent adverse events (“TEAEs”) and their severity were similar between the treatment groups. The number of TEAEs related to study products were also similar between the groups.
MVOR-1 Topline Results: In the DFD 29 group, 65.0% of subjects demonstrated IGA success, while 46.1% showed IGA success in the Oracea group and 31.2% of subjects showed IGA success in the placebo group. The difference between the DFD 29 and Oracea groups was statistically significant with a p-value of 0.007, and the difference between the DFD 29 and the placebo groups was statistically significant with a p-value of <0.001. the dfd 29 group showed a mean reduction of 21.3 lesions, while the oracea group showed a mean reduction of 15.9 lesions, and the placebo group showed a mean reduction of 12.2 lesions from baseline to week 16. the difference between the dfd 29 and oracea groups and the difference between the dfd 29 and placebo groups were statistically significant, each with a p-value of >0.001.
MVOR-2 Topline Results; In the DFD 29 group, 60.1% of subjects demonstrated IGA success, while 31.4% showed IGA success in the Oracea group and 26.8% of subjects showed IGA success in the placebo group. The difference between the DFD 29 and Oracea groups was statistically significant with a p-value of <0.001, and the difference between the dfd 29 and the placebo groups was statistically significant with a p-value of <0.001. the dfd 29 group showed a mean reduction of 18.4 lesions, while the oracea group showed a mean reduction of 14.9 lesions, and the placebo group showed a mean reduction of 11.1 lesions from baseline to week 16. the difference between the dfd 29 and oracea groups and the difference between the dfd 29 and placebo groups were statistically significant, each with a p-value of <0.001
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
1 mins