Knight Therapeutics gets Health Canada OK for Wynzora

Executive Summary

• Health Canada has granted approval for Wynzora, a topical cream for the treatment of psoriasis vulgaris in adults and adolescents aged 12 to 17, marking a significant commercial milestone for Knight Therapeutics.
• Knight Therapeutics acquired the Canadian rights to Wynzora in June 2025 through the acquisition of Paladin Pharma Inc. assets, following a November 2024 license agreement with MC2 Therapeutics.
• The approval is based on clinical trial data demonstrating superior efficacy compared to a vehicle control and non-inferiority to an active comparator (CAL/BDP gel/suspension), with a safety profile showing adverse reactions in less than 1% of patients.

Key Details

• Regulatory Approval: Health Canada approved Wynzora for the topical treatment of psoriasis vulgaris in adults and adolescents (12-17 years) for up to eight weeks.
• Product Composition: Wynzora is a white uniform cream containing 0.05 mg/g calcipotriol (CAL) and 0.5 mg/g betamethasone dipropionate (BDP).
• Acquisition Context: Knight Therapeutics obtained Canadian rights via the June 2025 acquisition of Paladin Pharma Inc. assets. Paladin had previously licensed commercialization rights in Canada from MC2 Therapeutics in November 2024.
• Clinical Trial Basis: Approval relies on two randomized, investigator-blind, vehicle-controlled eight-week trials (MC2-01-C2 and MC2-01-C7).
  • Efficacy: Wynzora demonstrated superior efficacy compared to vehicle (p < 0.0001) for all confirmatory endpoints.
  • Primary Endpoints:
    • Trial MC2-01-C2: Proportion of subjects with treatment success (minimum two-point decrease on PGA scale) at week 8.
    • Trial MC2-01-C7: Percentage change in modified Psoriasis Area and Severity Index (mPASI) from baseline to week 8.
  • Comparator: Wynzora was non-inferior to CAL/BDP gel/suspension (50 mcg/g CAL and 0.5 mL/g BDP) for PGA treatment success at week 8.
• Safety Profile: The most frequently reported adverse reactions were application site reactions (irritation, pain, pruritus, eczema, exfoliation, telangiectasia, folliculitis), all occurring at a frequency below 1%.
• Global Context: MC2 Therapeutics previously obtained FDA approval in the US on July 20, 2020, and approval in the first European country on July 9, 2021.
• Mechanism of Action: Wynzora targets keratinocyte proliferation/differentiation and inhibits pro-inflammatory cytokines (IL-23, IL-17A/F, TNF-alpha) via MC2's PAD Technology formulation.

Notable Quotes

• "By uniting two proven mechanisms in a once-daily cream, Wynzora addresses the twin challenges of adherence and symptom control. Health Canada's approval expands the treatment landscape with an evidence-based, practical therapy that can improve quality of life without adding monitoring burden," said Dr. Charles Lynde, MD, dermatologist at The Lynde Institute for Dermatology.
• "We are proud to introduce Wynzora to patients in Canada, offering an innovative treatment option for psoriasis vulgaris that combines efficacy with convenience. This launch underscores our commitment to improving quality of life for Canadian patients, while continuing our broader mission to bring innovative therapies to all markets we serve," said Samira Sakhia, president and chief executive officer, Knight Therapeutics.