Journey Medical has completed participant enrolment and randomisation in its Phase III clinical trials programme of DFD-29 (minocycline modified release capsules 40mg) to treat papulopustular rosacea (PPR).
The Phase III clinical trials programme, which is part of a partnership with Dr. Reddy’s Laboratories, has been designed for evaluating the tolerability, efficacy, and safety of DFD-29.
It includes two parallel-group, randomised, placebo-controlled, active-comparator, multicentre, and double-blind clinical trials, MVOR-01 and MVOR-02 (Minocycline versus Oracea in Rosacea).
These two trials are anticipated to support a new drug application (NDA) submission in the US, as well as a marketing authorisation application in Europe.
A total of 640 moderate to severe PPR adult patients have been enrolled in the two trials.
One trial was enrolling participants in the US and Europe while the other was enrolling patients only in the US.
In both the trials, participants were randomised in a 3:3:2 ratio to receive DFD-29, Oracea (Doxycycline capsules 40mg), or a placebo once a day for a period of 16 weeks.
The efficacy, tolerability, and safety of DFD-29 compared to a placebo to treat PPR is the primary objective of the trials.
The trials’ secondary objective is to assess DFD-29’s tolerability, efficacy, and safety compared to Oracea.
No drug-related serious adverse events and no major safety issues have been reported to date.
In a Phase II clinical study, DFD-29 40mg showed significantly better efficacy compared to doxycycline 40mg, a placebo, and DFD-29 20mg to treat PPR.
Journey Medical co-founder, president and CEO Claude Maraoui said: “We are thrilled to have completed enrolment in our two DFD-29 Phase III clinical trials and look forward to announcing topline data in the first half of 2023, with an NDA filing subsequently expected in the second half of 2023.
“Data from the Phase II multicentre clinical trial demonstrated that DFD-29 achieved nearly double the efficacy compared to doxycycline capsules 40mg on reducing total inflammatory lesions and Investigator’s Global Assessment (IGA) treatment success, suggesting the potential of DFD-29 as a more effective treatment option for rosacea.”