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Find Clinical Drug Pipeline Developments & Deals by MC2 Therapeutics
WYNZORA is a cream-based fixed dose combination of calcipotriene and betamethasone dipropionate for topical treatment of plaque psoriasis. It is based on PAD™ Technology, which enables stability of both calcipotriene and betamethasone dipropionate in aqueous formulation.
MC2-25 Cream is an effective isocyanate scavenger showing >90 % inhibition of protein carbamylation and counteracting the morphological skin changes induced by carbamylation as demonstrated in an in vitro reconstructed human uremic skin model.
MC2-25 CKD-aP is formulated to be highly tolerable, moisturizing, convenient to use and it quickly absorbs into the skin allowing patients to get on with their life and their daily routines.
In this collaboration Almirall will commercialize Wynzora® Cream for treatment of plaque psoriasis in Europe and MC2 Therapeutics will be responsible for manufacturing and supply.
Collaboration accelerates a Q1 2021 comprehensive launch of MC2’s WYNZORA® Cream to patients with plaque psoriasis in the US. WYNZORA® Cream is the first drug based on PADTM Technology – providing innovative solutions to unmet needs in chronic inflammatory conditions.
The FDA approval is based on the results of the US Phase 3 clinical trial1 against active comparator Taclonex® Topical Suspension (calcipotriene and betamethasone dipropionate.
The MAA is supported by two comprehensive Phase 3 trials1 including a trial conducted in EU evaluating the efficacy and safety of Wynzora® Cream compared to vehicle and active comparator Dovobet/Daivobet® Gel in patients with psoriasis vulgaris.