MC2-THERAPEUTICS
16.7.2020 13:15:13 CEST | Business Wire | Press release
MC2 Therapeutics, a commercial stage pharmaceutical company focused on topical therapies for chronic inflammatory conditions, today announced the submission of its Marketing Authorization Application (MAA) in EU for Wynzora® Cream (50 µg/g calcipotriol and 0.5 mg/g betamethasone (as dipropionate)) for the treatment of plaque psoriasis. The European filing follows the submission of a New Drug Application on Wynzora® Cream to the U.S. Food and Drug Administration (FDA) in September 2019.
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. The trial enrolled 490 patients at 32 clinical centers. Patients applied trial medication topically once daily for eight weeks. Dovobet/Daivobet® Gel is marketed as Taclonex® Topical Suspension in the US.
In this EU Phase 3 trial Wynzora® Cream demonstrated significantly greater treatment success compared to Dovobet/Daivobet® Gel, assessed by the proportion of subjects obtaining minimum two-points improvement in the Physician Global Assessment (PGA). Wynzora® Cream reached 51% PGA treatment success and a reduction from baseline in mPASI of 68%. In addition, the patient reported acceptability of treatment and the dermatology life quality index (DLQI) were rated significantly better for Wynzora® Cream than for Dovobet/Daivobet® Gel.
The pooled safety data from the two Phase 3 trials shows a favorable safety profile with no drug-related dermal adverse reactions exceeding 1%.
"With this submission we stay on track in our global development of Wynzora® Cream,” said Jesper J. Lange, CEO of MC2 Therapeutics and added: “Enabled by our PAD™ Technology, Wynzora® Cream is uniquely designed to address the three essentials of topical drugs - high efficacy, a favorable safety profile and a formulation that allows patients to quickly move on in daily routines within minutes of a toothbrushing. We want to use PAD™ Technology to set a new standard and release the full potential of novel topical drugs for the benefit of patients, physicians, payers and societies. Wynzora ® Cream represents all of that - no compromises”.
Psoriasis is a common, non-contagious, chronic skin disease, with no clear cause or cure. The negative impact of plaque psoriasis on people’s lives can be immense as it affects the appearance of the skin with red, scaly plaques and itching. Psoriasis affects people of all ages, and in all countries. The reported prevalence of psoriasis is 2-4% of the population making psoriasis a serious global problem with more than 100 million individuals affected worldwide. The flares of psoriasis can be unpredictable and significant comorbidities are common, including arthritis, cardiovascular diseases, metabolic syndrome, inflammatory bowel disease and depression.2
"More than 90% of psoriasis patients use topical drugs. However, there is a need for a significant upgrade of topicals to address the problem of treatment discontinuation and low adherence in topical therapies,” said Prof. Dr. Med. Matthias Augustin, Director Institute of Health Care Research in Dermatology and Nursing, University of Hamburg and lead principal investigator in the EU Phase 3 trial and continues: “Of course the efficacy and safety profile of a topical drug has to be compelling, but ease of use in daily routines is a third key element that can motivate patients to be adherent to topical treatment and thereby obtain satisfactory treatment outcomes and improved quality of life in the real-world setting. From a health economics point of view, optimizing real-world topical treatment satisfaction can be an important element in controlling the cost for our societies. As I see it, the clinical profile of Wynzora® Cream is a prime example of a treatment of plaque psoriasis that can address these challenges.”
About Wynzora® Cream
Wynzora® Cream is a cream-based fixed dose combination of calcipotriol and betamethasone dipropionate for topical treatment of plaque psoriasis. Wynzora® Cream is based on PAD™ Technology, which uniquely enables stability of both calcipotriol and betamethasone dipropionate in a convenient-to-use aqueous formulation. In the phase 3 trials conducted at multiple sites in the US and the EU, Wynzora® Cream has demonstrated significantly greater efficacy compared to Taclonex® Topical Suspension and Dovobet/Daivobet® gel. The unique combination of significant clinical efficacy, a favorable safety profile and high convenience of Wynzora® Cream holds promise to less treatment discontinuation and overall better patient satisfaction in topical treatment of plaque psoriasis in the real-world setting.
About MC2 Therapeutics
MC2 Therapeutics is a privately held commercial stage pharmaceutical company focused on novel topical therapies for chronic inflammatory conditions. Using its PAD™ Technology it aims to set a new standard of treatment experience for patients and to release the full potential of novel topical drugs for the benefit of patients, physicians, payers and societies. PAD™ Technology is the basis for its innovative pipeline of drug candidates within atopic dermatitis, uremic pruritus, lichen sclerosus and dry eye.
For additional information on MC2 Therapeutics, please visit www.mc2therapeutics.com
References:
1
EudraCT no: 2018-001970-66 / NCT03802344 (EU Phase 3 trial); NCT03308799 (US Phase 3 trial)
2
WHO Global report on Psoriasis 2016
View source version on businesswire.com: https://www.businesswire.com/news/home/20200716005526/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Cognite Positioned as a Front Runner in LNS Research Solution Selection Matrix for Industrial AI Platforms23.4.2026 20:00:00 CEST | Press release
Cognite, the global leader in Industrial AI, has been named a Front Runner in the LNS Research Solution Selection Matrix for Industrial AI Platforms (SSM). The LNS Research SSM evaluates vendors using a rigorous methodology that leverages its “3P” framework—Product, Potential, and Presence—to assess both current capabilities and future readiness. Within the report, Cognite is recognized in three key areas: depth in user-centric industrial AI applications, its knowledge graph-based data model, and its strong partner ecosystem. Together, all three give Cognite the ability to unify and contextualize complex industrial data, enabling organizations to operationalize AI at scale. “Cognite brings a sophisticated data model built for industrial complexities, along with advanced analytics and AI-driven insights, which is crucial for industrial organizations to achieve meaningful productivity gains and enterprise-wide ROI,” said Vivek Murugesan, Research Analyst at LNS Research. “These capabilit
Venture Global Announces Closing of $750,000,000 Senior Secured Notes by Venture Global Calcasieu Pass, LLC23.4.2026 19:47:00 CEST | Press release
Venture Global, Inc. (“Venture Global”, NYSE: VG) announced today that its subsidiary, Venture Global Calcasieu Pass, LLC (“VGCP”) has closed an offering of $750,000,000 aggregate principal amount of 6.000% senior secured notes due 2036 (the “Notes”). The Notes will mature on May 1, 2036. VGCP used the net proceeds from the offering, together with cash on hand and proceeds received from certain hedge terminations, for the prepayment, in full, of VGCP’s outstanding term loans, and to pay fees and expenses in connection with the offering. The Notes are guaranteed by TransCameron Pipeline, LLC (VGCP’s affiliate). The Notes are secured on a pari passu basis by a first-priority security interest in the assets that secure VGCP’s existing senior secured first lien credit facilities and VGCP’s existing senior secured notes. The Notes were not registered under the Securities Act of 1933, as amended (the “Securities Act”) or the securities laws of any state or other jurisdictions, and the Notes
Does Muscle Composition Identify High-Risk Individuals in Chronic Kidney Disease? New AMRA Medical Study Says Yes, Reveals Strong Link to Mortality23.4.2026 17:10:00 CEST | Press release
AMRA Medical researchers recently set out to answer the question: what is the relationship between adverse muscle composition (AMC) and mortality in kidney disease? Recent findings demonstrate that AMC, characterized by low muscle volume z-score and high muscle fat infiltration, is an independent and strong predictor of all-cause mortality in individuals with chronic kidney disease (CKD). The findings, published in Clinical Journal of the American Society of Nephrology, were based on data from the UK Biobank imaging study and further reinforce the clinical relevance of MRI-derived muscle biomarkers in identifying high-risk populations across chronic diseases. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260423198497/en/ AMRA's MRI-based muscle biomarkers in clinical trials Researchers from AMRA, alongside our collaborators at Linköping University (LiU), analyzed 894 participants with CKD using AMRA’s MRI-based body composi
Diligent Unveils AI Board Member and Agentic GRC Workforce at Elevate 202623.4.2026 15:00:00 CEST | Press release
Diligent’s agentic AI strengthens board oversight and transforms how GRC teams work — reducing manual effort and outside-advisor dependency, tightening control over sensitive workflows and enabling leaders to make faster, more defensible decisions Diligent, the AI leader in governance, risk and compliance (GRC) SaaS solutions, today unveiled a new generation of autonomous AI agents, including AI Board Member — a secure AI assistant for directors — and a coordinated network of agents embedded across the Diligent One Platform. Accessible through a single command center, agents automate multi-step workflows across governance, risk, compliance and third-party management, giving organizations the impact of a “GRC manager” without adding headcount. “AI supercharges teams that embrace it, and boards are no exception,” said Brian Stafford, President and CEO of Diligent. “With AI Board Member and a network of autonomous agents woven through the Diligent One Platform, we’re giving the C-suite an
Safe Software Bolsters Leadership Team with CFO and CPO Appointments to Drive Next Phase of Growth23.4.2026 15:00:00 CEST | Press release
CFO and CPO executive hires to enhance operational and financial performance on the company’s path to $250M by 2028 Safe Software (Safe), creator of FME, the only All-Data, Any-AI enterprise integration platform, today welcomes two executives to its leadership team as it moves into the next phase of growth. Judd Lee has been appointed as the company’s Chief Financial Officer (CFO), and Vanessa Ribreau has been appointed as Chief People Officer (CPO). Having recently crossed $100M in revenue, the expanded leadership team will further enable the company to scale as it accelerates toward its goal of reaching $250M in revenue by 2028. Judd Lee is a seasoned CFO with over 15 years of experience partnering closely with CEOs to align financial strategy and accelerate sustainable growth. He is known for his strong commitment to mentorship and for building high-performing global teams rooted in trust, morale and a shared sense of purpose. With more than two decades of financial leadership acros
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom