Knight Therapeutics Announces Health Canada Approval for WYNZORA® to Treat Psoriasis Vulgaris

MONTREAL, Dec. 18, 2025 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a pan-American (ex-USA) specialty pharmaceutical company, announced today that Health Canada has approved WYNZORA^®, a white uniform cream containing 0.05 mg/g of calcipotriol (CAL) and 0.5 mg/g of betamethasone dipropionate (BDP), indicated for the topical treatment of psoriasis vulgaris in adults and adolescents aged 12-17 years for up to 8 weeks.¹

Knight obtained the Canadian rights to WYNZORA^® through its June 2025 acquisition of the assets of Paladin Pharma Inc. (“Paladin”). In November 2024, Paladin had entered into a license agreement with MC2 Therapeutics ("MC2") to commercialize WYNZORA^® in Canada. MC2 is a private pharmaceutical company based in Hørsholm, Denmark and in Guildford, United Kingdom.

“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 in Markham, Ontario.

“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 CEO, Knight Therapeutics Inc.

About WYNZORA^®

WYNZORA^® is a cream-based fixed dose combination of CAL and BDP for topical treatment of psoriasis vulgaris developed by MC2. WYNZORA^® has a broad mode of action by targeting keratinocyte proliferation and differentiation and inhibiting expression of pro-inflammatory hallmark cytokines such as IL-23, IL-17A/F and TNF-α. In WYNZORA^®, the combination of CAL and BDP has greater anti-inflammatory and anti-proliferative effects than either component alone. WYNZORA^® is uniquely enabled by MC2’s formulation and drug delivery system PAD Technology^TM, allowing an effective convenient-to-use aqueous formulation. MC2 obtained approval of WYNZORA^® in the US by the FDA on July 20^th, 2020, and WYNZORA^® was approved in the first country in Europe on July 9^th, 2021. 

The Health Canada approval is based on the results of two randomized, investigator-blind, vehicle-controlled 8-week trials (MC2-01-C2 and MC2-01-C7) in adults. CAL/BDP gel/suspension was included as an active comparator, and the trials were designed to show superiority to vehicle and non-inferiority of WYNZORA^® to CAL/BDP (50 mcg/g CAL and 0.5 mL/g BDP) gel /suspension.^2,3

The primary efficacy endpoint in trial MC2-01-C2 was the proportion of subjects in each treatment group with treatment success at Week 8, defined as a minimum 2-point decrease from baseline to week 8 on the Physician Global Assessment (PGA) scale of disease severity on the trunk and limbs. This was the secondary endpoint trial MC2-01-C7. The primary efficacy endpoint in trial MC2-01-C7 was the percentage change in modified Psoriasis Area and Severity Index (mPASI) on the body (trunk and/or limbs) from Baseline to Week 8. This was the secondary endpoint for trial MC2-01-C2.¹

Results from both primary and secondary efficacy endpoints in both MC2-01-C2 and MC2-01-C7 demonstrated that WYNZORA^® had superior efficacy compared to vehicle (p < 0.0001) for all confirmatory efficacy endpoints in treating psoriasis on the body (trunk and/or limbs). WYNZORA^® demonstrated a statistically significant, greater PGA treatment success and mean percentage change from Baseline in mPASI at Week 8 compared to the vehicle. In addition, WYNZORA^® was non-inferior to CAL/BDP gel/ suspension at Week 8 for PGA treatment success [Study MC2-01-C2 Difference 14.6% (95% CI:7.6%, 21.6%); Study MC2-01-C7 Difference 7.9% (95% CI: -1.7, 17.5)]; and mPASI [Study MC2-01-C2 Difference 12.02% (96.7% CI: 7.00, 17.04); Study MC2-01-C7 Difference -4.2 (95% CI: -9.6, 1.2)].^1,2,3 The most frequently reported adverse reactions were "Application site reactions" including application site irritation, pain, pruritus, eczema, exfoliation, telangiectasia and folliculitis. All reported adverse reactions were seen at a frequency below 1%.¹

About Psoriasis

Psoriasis is a chronic, immune-mediated inflammatory disease of the skin.⁴ It is often characterized by sharply demarcated, scaly dull-red plaques, particularly on the extensor parts of limbs and on the scalp.^5,6 An estimated 1 million Canadians and 125 million people worldwide, are affected by psoriasis.⁶ Chronic plaque psoriasis (psoriasis vulgaris) is the most common type and accounts for 80% to 90% of cases. ⁷ The severity of disease may vary among patients, ranging from mild to moderate to severe.⁷ The clinical course of psoriasis is unpredictable, with fluctuating severity overtime.⁸

Common symptoms of psoriasis include itching, redness, flaking and scaling. Itch is considered one of the most bothersome symptoms, with patients reporting itch reduction the most important treatment goal.⁹ Yet, the disease burden of psoriasis extends far beyond the physical dermatological symptoms. Psoriasis is considered a systemic inflammatory disorder, similar to rheumatoid arthritis, Crohn’s disease, and systemic lupus erythematosus.¹⁰

About Knight Therapeutics Inc.

Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing and commercializing pharmaceutical products for Canada and Latin America. Knight’s Latin American subsidiaries operate under United Medical, Biotoscana Farma and Laboratorio LKM. Knight Therapeutics Inc.'s shares trade on TSX under the symbol GUD. For more information about Knight Therapeutics Inc., please visit the company's web site at www.knighttx.com or www.sedarplus.ca.

Forward-Looking Statements for Knight

This document contains forward-looking statements for Knight Therapeutics Inc. and its subsidiaries. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight Therapeutics Inc. considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight Therapeutics Inc. and its subsidiaries, may ultimately prove to be incorrect. Factors and risks which could cause actual results to differ materially from current expectations are discussed in Knight Therapeutics Inc.'s Annual Report and in Knight Therapeutics Inc.'s Annual Information Form for the year ended December 31, 2024, as filed on www.sedarplus.ca. Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information or future events, except as required by law.

CONTACT INFORMATION FOR KNIGHT:

References:

1. Knight Therapeutics, Inc. Wynzora^® (calcipotriol and betamethasone dipropionate cream) [product monograph]. Montreal, QC: Knight Therapeutics, Inc.; November 21, 2025.
2. Pinter A, Reich A, Arenberger P, et al. Randomized Phase 3 trial demonstrating high efficacy, favourable safety and convenience of a novel calcipotriol and betamethasone dipropionate cream for the treatment of psoriasis. J Eur Acad Dermatol Venereol. 2023;37(11):2327-2335. doi:10.1111/jdv.19330
3. Stein Gold L, Green LJ, Dhawan S, Vestbjerg B, Praestegaard M, Selmer J. A Phase 3, Randomized Trial Demonstrating the Improved Efficacy and Patient Acceptability of Fixed Dose Calcipotriene and Betamethasone Dipropionate Cream. J Drugs Dermatol. 2021;20(4):420-425. doi:10.36849/JDD.2021.5653
4. Parisi R, Symmons DP, Griffiths CE, Ashcroft DM; Identification and Management of Psoriasis and Associated ComorbidiTy (IMPACT) project team. Global epidemiology of psoriasis: a systematic review of incidence and prevalence. J Invest Dermatol. 2013;133(2):377-385. doi:10.1038/jid.2012.339
5. Canadian Psoriasis Guidelines Committee. Canadian Guidelines for the Management of Plaque Psoriasis. Canadian Dermatology Association; 2009. Accessed May 21, 2025. https://www.dermatology.ca/wp-content/uploads/2012/01/cdnpsoriasisguidelines.pdf
6. Canadian Dermatology Association. Psoriasis. Accessed May 21, 2025. https://dermatology.ca/public-patients/diseases-conditions/skin-conditions/psoriasis/
7. Kim WB, Jerome D, Yeung J. Diagnosis and management of psoriasis. Can Fam Physician. 2017;63(4):278-285.
8. Blackstone B, Patel R, Bewley A. Assessing and Improving Psychological Well-Being in Psoriasis: Considerations for the Clinician. Psoriasis (Auckl). 2022;12:25-33. Published 2022 Mar 25. doi:10.2147/PTT.S328447.
9. Lebwohl M, Langley RG, Paul C, et al. Evolution of Patient Perceptions of Psoriatic Disease: Results from the Understanding Psoriatic Disease Leveraging Insights for Treatment (UPLIFT) Survey. Dermatol Ther (Heidelb). 2022;12(1):61-78. doi:10.1007/s13555-021-00635-4.
10. Lebwohl M. Psoriasis. Ann Intern Med. 2018;168(7):ITC49-ITC64. doi:10.7326/AITC201804030

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