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
Rapid Medical™’s DISTALS Trial Overwhelmingly Positive, Demonstrating Superior Reperfusion with TIGERTRIEVER™ 13 in Medium Vessel Stroke6.2.2026 20:30:00 CET | Press release
TIGERTRIEVER™ 13 is the first device shown to meet safety and effectiveness endpoints for restoring blood flow in smaller but critical areas of the brain, accounting for almost 50% of all ischemic strokes Rapid Medical™, a leading developer of active endovascular devices, today announced late-breaking results from the DISTALS multicenter, randomized controlled trial showing that TIGERTRIEVER™ 13 achieved superior brain tissue reperfusion with an excellent safety profile when compared with medical management in medium vessel occlusion (MVO) stroke. The findings were presented in the main closing session at the 2026 International Stroke Conference (ISC). Top-line results showed that the TIGERTRIEVER™ 13 arm demonstrated 3x more successful reperfusion without symptomatic intracranial hemorrhage (sICH) compared to medical management–86.3% vs 27.7% (p < 0.001). Notably, zero sICH events were reported in the randomized treatment arm treated with TIGERTRIEVER 13. By comparison, sICH rates rep
Al Barari Breaks Ground on The Cape, The Final Chapter of a Legacy6.2.2026 15:46:00 CET | Press release
Al Barari, Dubai’s pioneering nature-led community, has officially marked the groundbreaking of The Cape, its final signature residential development, celebrating two decades of visionary craftsmanship and a continued commitment to creating harmonious living environments rooted in nature. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260206475199/en/ Hazza Zaal, CEO of Al Barari Real Estate Group, alongside the Sales and Construction teams at The Cape Groundbreaking Ceremony, marking a milestone in Al Barari’s final signature development. (Photo: AETOSWire) The milestone ceremony signals the beginning of a landmark chapter for Al Barari, as The Cape represents the culmination of a 20-year legacy defined by intentional design, wellbeing-focused living, and immersive natural landscapes. Located within Dubai’s green heart, The Cape introduces an enriched lifestyle experience surrounded by lush botanical settings, gentle water
Andersen Consulting indgår samarbejdsaftale med Alfa Group6.2.2026 15:41:00 CET | Pressemeddelelse
Andersen Consulting styrker sit udbud inden for cybersikkerhed gennem samarbejdet med Alfa Group, der er en førende teknologivirksomhed med næsten tre årtiers erfaring i at hjælpe organisationer med at beskytte og optimere deres drift. Alfa Group blev grundlagt i 1996 og har hovedsæde i Rom. Virksomheden leverer avancerede løsninger inden for cybersikkerhed, registrering og forebyggelse af svindel, hændelseshåndtering og sårbarhedsstyring samt udvalgte ydelser inden for processtyring. Deres proprietære teknologi, N.O.V.A., er en fuldt integreret administreret tjeneste, der kombinerer Alfa Groups innovationer med tredjepartssystemer for at beskytte digitale infrastrukturer, reducere risici og øge den operationelle effektivitet. Virksomheden betjener kunder på tværs af brancher, herunder finans og forsikring, forsvar og rumfart, telekommunikation, fremstilling, energi og medicinalindustrien. "Vores samarbejde med Andersen Consulting giver os mulighed for at udvide vores rækkevidde og lev
Quantfury and Sandwich Launch Commercial Series to Encourage Better Choices in Retail Trading6.2.2026 15:00:00 CET | Press release
Quantfury Trading Americas Limited (“Quantfury”), a global brokerage offering commission-free trading at real-time spot prices from major exchanges, has partnered with Sandwich, a leading creative agency for tech and product videos, to produce a Social Responsibility Commercial Series. The series of commercials incorporates clear, engaging storytelling to prompt viewers to think about common retail trading behaviors—especially high-energy marketing, gamification of speculation, and heavy focus on potential gains without equal attention to risks—and to choose more thoughtful, informed approaches. Lev Mazur, Founder of Quantfury, said: “It’s a pleasure to work with Sandwich, whose visual storytelling is outstanding. Since day one, Quantfury has aimed to question and improve the standard practices in the global retail trading industry.” Adam Lisagor, Founder of Sandwich, added: “A good investment is a story. Quantfury stood out by wanting to tell a real, interesting story first—rather tha
JSS: 2025 Sake Exports Grew Steadily, Reaching a Record 81 Markets6.2.2026 04:00:00 CET | Press release
Sake exports continued to expand in 2025 in both value and volume, with export destinations reaching a record 81 countries and regions. Export value increased 6% year on year to 45.9 billion yen, while export volume rose 8% to 33.55 million liters (3.73 million cases on a 9-liter basis), marking the second-highest export performance on record. The average export unit price per 750 ml bottle declined 2% year on year to 1,026 yen. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260205671686/en/ Sake Export Performance by Country (Top 10, 2025) Export value has nearly doubled since 2020, and the CAGR over the past five years reached 14%. This underscores sake’s position as a high-growth category globally. Asia remained the largest export destination, with export value totaling 28.8 billion yen, representing an 8% increase year on year and accounting for 63% of total export value. North America recorded exports of 12.4 billion ye
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