DFD-29 Demonstrates Superiority Over Oracea and Placebo in Phase 3 Rosacea Trials

Journey Medical查看公司主页's DFD-29查看药品详情 (minocycline查看药品详情 hydrochloride modified release capsules) has shown statistically significant superiority over both Oracea查看药品详情 (doxycycline查看药品详情) and placebo in treating moderate-to-severe papulopustular rosacea (搜索)搜索该疾病 in adults. The positive topline results come from two Phase 3 clinical trials, MVOR-1 and MVOR-2, potentially paving the way for a new treatment paradigm for millions affected by rosacea.

Phase 3 Trial Results

The MVOR-1 and MVOR-2 trials randomized subjects in a 3:3:2 ratio to receive DFD-29查看药品详情, Oracea查看药品详情 (40 mg doxycycline查看药品详情), or placebo once daily for 16 weeks. The primary objective was to evaluate the safety and efficacy of DFD-29 compared to placebo, while the secondary objective assessed its efficacy compared to Oracea. Both trials successfully achieved the co-primary and all secondary endpoints.

In MVOR-1, 65% of subjects in the DFD-29查看药品详情 group achieved Investigator's Global Assessment (IGA) success, compared to 46.1% in the Oracea查看药品详情 group (p=0.007) and 31.2% in the placebo group (p<0.001). The DFD-29 group also demonstrated a mean reduction of 21.3 lesions from baseline to week 16, significantly greater than the 15.9 lesions in the Oracea group and 12.2 lesions in the placebo group (p<0.001 for both comparisons).

Similarly, MVOR-2 showed that 60.1% of subjects in the DFD-29查看药品详情 group achieved IGA success, compared to 31.4% in the Oracea查看药品详情 group (p<0.001) and 26.8% in the placebo group (p<0.001). The mean lesion reduction from baseline to week 16 was 18.4 in the DFD-29 group, 14.9 in the Oracea group, and 11.1 in the placebo group (p<0.001 for both comparisons).

Safety Profile

Both trials reported no major safety issues and no serious adverse events related to the study products. The number and severity of treatment-emergent adverse events (TEAEs) were similar across all treatment groups, including those related to the study products.

Implications for Rosacea Treatment

"We are very pleased with the positive results for our two Phase 3 clinical trials evaluating DFD-29查看药品详情 for the treatment of rosacea (搜索)搜索该疾病, which demonstrated statistical superiority over both Oracea查看药品详情 and placebo," said Claude Maraoui, Co-Founder, President, and Chief Executive Officer of Journey Medical查看公司主页. "With these clinically meaningful outcomes, DFD-29 has the potential to be the new treatment paradigm for the millions of patients suffering from rosacea as the lowest-dose oral minocycline查看药品详情 on the market."

Journey Medical查看公司主页 anticipates submitting a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for DFD-29查看药品详情 in the second half of 2023.