Calcipotriene, Betamethasone Dipropionate Cream Meets Phase 3 Trial Endpoints

Calcipotriene and betamethasone dipropionate cream met its primary endpoint for treating plaque psoriasis during its phase 3 trial in the European Union, according to an announcement from MC2 Therapeutics.

The trial involved a comparison of 2 calcipotriene and betamethasone dipropionates—Wynzora cream and Daivobet gel. The results revealed Physician Global Assessment (PGA) treatment success for Wynzora was 52%, with the change from baseline in modified Psoriasis Area and Severity Index (mPASI) being 68% for Wynzora Cream, significantly higher than Daivobet at week 4.

Patient-reported outcomes for the calcipotriene and betamethasone dipropionates were also significant as patients reported treatment convenience at week 4 and week 8. Also, there was a change in the dermatology life quality index at week 4 and week 8.

The FDA is reviewing the company's application for the cream, which will also be submitted for review in the EU as well. The treatment is a once-daily, non-greasy produce that absorbs into the skin within a few minutes using the company's PAD Technology.

“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,” said Jesper Lange, LLM, chief executive officer of MC2 Therapeutics.

“Wynzora Cream takes the treatment experience in daily routines to a new level. Our PAD Technology has enabled an aqueous cream formulation that is designed for high convenience in daily routines illustrated by the positive patient reported treatment convenience and quality of life outcomes in our Phase 3 trials. This is a key component of treatment in real life settings,” said Lange.