The study examined 490 plaque psoriasis patients across 32 clinical centers in Poland, Germany and Czech Republic, where researchers had participants apply the cream once daily for eight weeks.
Results showed the betamethasone dipropionate and calcipotriene cream displayed greater efficacy in comparison to the gel with a Physician Global Assessment (PGA) treatment success of 52% at week 8 and while also exhibiting a 68% reduction from the modified Psoriasis Area and Severity Index (mPASI) baseline at week 4. The topical also showed a favorable safety profile in the phase 3 study.
Additionally, MC2 Therapeutics’ new cream revealed better patient reported outcomes compared to the topical gel with p<0.001 Patient Reported Treatment Convenience (PTCS) at week 4 and p<0.0001 at week 8, as well as an alteration from the Dermatology Life Quality Index (DLQI) baseline with p<0.05 at week 4 and 8.
“We continue to be impressed by the performance of Wynzora Cream in clinical trials. With a PGA treatment success of 52% and 68% reduction in mPASI and a very favorable safety profile, Wynzora Cream is delivering on its promise to provide high comfort to physicians and patients in treating plaque psoriasis,” states Lange.
Complete data results from the study will be presented at clinical conferences in the upcoming year. MC2 Therapeutics also plans to apply for marketing authorization in the EU during the first quarter of 2020.
MC2 Therapeutics Announces Positive Top-line Results from EU Phase 3 Head-to-Head trial Comparing Wynzora™ Cream to Daivobet® Gel in Patients with Psoriasis. mc2therapeutics.com. https://www.mc2therapeutics.com/news/?nid=5df9ddee44c43. Published December 18, 2019. Accessed December 20, 2019.