MC2 Therapeutics announced the U.S FDA has approved Wynzora Cream (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%) for once-daily topical treatment of plaque psoriasis in adults 18 years of age or older. Wynzora Cream is based on the company’s PAD Technology, which uniquely stabilizes calcipotriene and betamethasone dipropionate in a convenient-to-use aqueous formulation.
The FDA approval was based on the results of a randomized, investigator-blind, multicenter, vehicle- and comparator-controlled, parallel-group phase 3 clinical trial evaluating Wynzora Cream against active comparator Taclonex Topical Suspension (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%). The trial enrolled 794 patients who were randomized to apply one topical treatment a day for 8 weeks. The primary efficacy endpoint was the proportion of patients with PGA treatment success at week 8 defined as at least a 2-grade improvement from baseline in PGA to “clear” or “almost clear”. The difference in PGA treatment success to the active comparator was 14.6% in favor of Wynzora Cream. Reduction of itch as defined by at least a 4-point improvement in the 11-point peak pruritus numeric rating scale (NRS) from baseline to week 4 was assessed among patients who had at least a peak pruritus NRS score of 4 at baseline. A higher proportion of patients achieved at least a 4-point improvement in the peak pruritus NRS score at week 4 in the Wynzora Cream group (60.3%) compared to vehicle (21.4%). The most common side effects included upper respiratory infection, headache, and application site irritation.
“The FDA approval marks an important milestone for patients with plaque psoriasis”, stated Jesper J. Lange, CEO of MC2 Therapeutics and continued: “Our PAD Technology has uniquely enabled us to develop Wynzora Cream with no compromises. It drives the compelling efficacy and safety data of Wynzora Cream and transforms that data into impact for patients through a convenient formulation that allows patients to move on within minutes of a morning routine. It puts patients back in control of therapy and daily life.”
About Wynzora Cream
Wynzora Cream is a cream-based fixed dose combination of calcipotriene and betamethasone dipropionate, formulated on PAD Technology. PAD Technology formulations are tailor-made to meet the target product profile for a selected product candidate. This technology enables the mixing of oil and water into a cream using just a fraction of the emulsifier required in conventional creams and lotions. PAD Technology formulations allow for high penetration of active ingredients to the target tissue, improved solubility and stability of active ingredients, high tolerability and treatment convenience. For additional information, visit Wynzora.com.
About Plaque Psoriasis
Psoriasis is a common, non-contagious, chronic skin disease, with no clear cause or cure, manifesting as red, scaly plaques. According to the National Psoriasis Foundation, itch is present in between 70 and 90 percent of psoriasis patients, and together with flaking and scaling, itching is the most burdensome symptom to patients. The appearance of flares of psoriasis can be unpredictable and affects people of all ages. Approximately 2-4% of the population psoriasis have psoriasis, with more than 100 million individuals affected worldwide.