Business Wire

MC2 Therapeutics Announces Submission of Marketing Authorization Application in EU for Wynzora ® Cream (50 µg/g calcipotriol and 0.5 mg/g betamethasone (as dipropionate))

Share
Some of the content included in this release is not shown due to cookie policy. The external content is hosted by the following providers:
  • cts.businesswire.com
By viewing the external content you accept the terms and conditions of the third party that is hosting the content.

You can change your cookie consent to allow this kind of content permanently or click the button below to allow only the content in this 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® Creamrepresents 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:
1EudraCT no: 2018-001970-66 / NCT03802344 (EU Phase 3 trial); NCT03308799 (US Phase 3 trial)
2WHO Global report on Psoriasis 2016

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

MC2 Therapeutics
Investors: Lonni Goltermann, +45 2018 1111 or log@mc2therapeutics.com

Media:
EU: Molecule A/S: Mette Thorn Sorensen, +45 4138 4300 or mts@moleculeconsultancy.com
US: Amy Phillips, +1 412.327.9499 or amyphillipspr@gmail.com

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.com

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

SES Update on Annual General Meeting Agenda14.3.2025 20:41:00 CET | Press Release

SES S.A. (“SES” or the “Company”) today issued the following statements in relation to the Company’s upcoming Annual General Meeting (“AGM”), taking place on 3 April 2025: Proposed Additions to SES’s Board of Directors The Company is pleased to propose the addition of two new members, Ellen Lord and John Shaw, to its Board of Directors. Ellen Lord is the former Under Secretary of Defense for Acquisition and Sustainment of the United States Department of Defense and has board experience with listed and non-listed companies, including Voyager Space Holdings Inc., National Defense Industrial Association and Defense Technology Initiative. John Shaw is a former Deputy Commander of the U.S. Space Force and first Commander of the USSF Space Operations Command and Combined Forces Space Component Command. The Company believes that adding the unique and valuable experience and skillsets of Ellen and John to its Board, both of whom bring direct experience in U.S. Department of Defense and U.S. Sp

bd-capital raises €430 million for Second Fund14.3.2025 10:35:00 CET | Press Release

bd-capital, the pan-European, operator-led investment firm, is pleased to announce the final closing of its second fund, bd-capital Fund 2 (“Fund 2”), at €430 million. The fund closed more than 20% over its target of €350 million after less than twelve months in the market. With the closing of Fund 2, bd-capital’s assets under management have increased to over €800 million. Commitments to Fund 2 were secured from a diverse cohort of institutional investors, including insurance companies, pension funds, sovereign wealth funds and family offices. In addition to Europe and the Middle East, a significant proportion of capital came from North American investors. bd-capital’s Managing Partners, Andy Dawson and Richard Baker, said: “We are incredibly grateful for the continued support we have received from our existing limited partners and are delighted to have welcomed such a fantastic group of new investors into Fund 2. To have exceeded our fundraising target in a relatively short timeframe

Reply at NVIDIA GTC 2025: How AI Agents and Digital Humans are Redefining Customer Experience14.3.2025 10:00:00 CET | Press Release

Reply, a global systems integrator and consulting firm, specialised in AI-driven solutions and intelligent systems, is taking part in NVIDIA GTC 2025, a premier conference hosted by NVIDIA that is focused on the future of accelerated computing and AI, held from March 17–21 in San Jose, California. As part of the event, Roberto Del Ponte, Associate Partner at Infinity Reply, will take the stage for an insightful panel discussion titled “Customer Service 2.0: Transforming Experiences with AI Agents and Digital Humans” on March 19, 2025, from 11:00 AM to 12:00 PM PT. The panel will explore the evolving role of AI-driven customer interactions, focusing on AI agents and digital humans. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250314195701/en/ Reply’s participation in NVIDIA GTC 2025 underscores its commitment to advancing the field of digital humans and emotionally intelligent AI solutions. (Graphic: Business Wire) The disc

Galderma Successfully Placed an Inaugural EUR 500 Million Single Tranche Eurobond and New Dual Tranche CHF 435 Million CHF Bonds14.3.2025 07:00:00 CET | Press Release

Galderma Group AG (SWX:GALD): NOT FOR DISTRIBUTION IN THE UNITED STATES OR IN ANY OTHER JURISDICTION IN WHICH SUCH DISTRIBUTION WOULD BE RESTRICTED BY APPLICABLE LAW OR REGULATION. Galderma (SIX: GALD) has made significant progress on its refinancing strategy to spread out its maturity profile, diversify funding sources and reduce its interest costs, by successfully issuing the following bonds: EUR 500 million bond, with a 5-year maturity and a 3.5% fixed-rate annual coupon CHF 190 million bond, with a 4-year maturity and a 1.4025% fixed-rate annual coupon CHF 245 million bond, with a 8-year maturity and a 1.8098% fixed-rate annual coupon The payment dates are March 20, 2025, for the Eurobond and the CHF bonds. The bonds will be listed on the SIX Swiss Exchange. The EUR transaction was led by BNP Paribas, J.P. Morgan, Mizuho, and Santander as active bookrunners, while the CHF transaction was led by UBS and BNP Paribas. Galderma is rated BBB (stable outlook) by Fitch and Fitch is expect

Cessna Citation X and X+ Customers Benefit From Starlink High-Speed Internet Availability13.3.2025 16:00:00 CET | Press Release

Textron Aviation today announced an additional high-speed internet connectivity solution for the Cessna Citation X and X+ following the Federal Aviation Administration’s (FAA) issuance of AeroMech’s Supplemental Type Certificate (STC) for Starlink high-speed internet connectivity. AeroMech’s STC utilizes Starlink’s constellation of Low Earth Orbit (LEO) satellites to provide more reliable connectivity over land, water and remote areas, where traditional in-flight Wi-Fi may not have service. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250313683324/en/ Textron Aviation announced an additional high-speed internet connectivity solution for the Cessna Citation X and X+ following the Federal Aviation Administration’s (FAA) issuance of AeroMech’s Supplemental Type Certificate (STC) for Starlink high-speed internet connectivity. (Photo Credit: Textron Aviation) Beechcraft, Cessna and Hawker customers receive factory-direct suppor

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
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye