July 28,2020
MC2 Therapeutics, a commercial stage pharmaceutical company developing a new standard of topical therapies for chronic inflammatory conditions, announced today that the U.S. Food and Drug Administration (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.
The FDA approval is based on the results of the US Phase 3 clinical trial (1) against active comparator Taclonex® Topical Suspension (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%). A total of 794 patients were randomized in this trial and 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% (95% CI; 7.6%, 21.6%) 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%).
“Wynzora® Cream is a novel topical treatment for plaque psoriasis which offers a unique combination of high efficacy, favorable safety and excellent treatment convenience in a single product,” said Linda Stein Gold, MD, Director of Dermatology Clinical Research at Henry Ford Health System in Detroit, Michigan, and lead principal investigator in the study.
Studies show that more than half of psoriasis patients are dissatisfied with their treatment and that a large proportion of patients are not treated at all (2).
“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."
Founder and Executive Chairman of MC2 Therapeutics, Mads Clausen concurred: "Wynzora® is a prime example of what we envision PAD™ Technology can do to help patients, physicians and payers release the full potential of topical therapies in real world settings."
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