Journey Medical Corporation (NASDAQ:DERM) shares are trading lower after the company announced topline results from the two Phase 3 trials, evaluating Minocycline Hydrochloride Modified Release Capsules (DFD-29) for adult patients with moderate-to-severe papulopustular rosacea.
DFD-29 is being developed for rosacea in collaboration with Dr. Reddy's Laboratories Ltd (NYSE:RDY).
The company said the trials - Minocycline Versus Oracea in Rosacea-1 (MVOR-1) and Minocycline Versus Oracea in Rosacea-2 (MVOR-2), achieved the co-primary and all secondary endpoints and subjects completed the 16-week treatment with no significant safety issues.
In MVOR-1, In the DFD-29 group, 65.0% of subjects demonstrated IGA success, compared to 46.1% in the Oracea (Doxycycline) group and 31.2% 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 vs. 15.9 in the Oracea group and 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.
In MVOR-2, in the DFD-29 group, 60.1% of subjects demonstrated IGA success vs. 31.4% and 26.8%.
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 vs. 14.9 in the Oracea group vs. 11.1 lesions from baseline to week 16.
Recently, Journey Medical announced topline data from the Phase 1 clinical trial assessing the impact of DFD-29 on the microbial flora of healthy adults.
Price Action: DERM shares are down 25% at $2.13 on the last check Tuesday.
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