MC2 Therapeutics Announces Positive Top-line Results from EU Phase 3 Head-to-Head trial Comparing Wynzora(TM) Cream to Daivobet(R) Gel in Patients with Psoriasis
- Wynzora(TM) Cream demonstrates statistically significantly better treatment efficacy compared to Daivobet(R) Gel.
- Wynzora(TM) Cream demonstrates statistically significantly better treatment convenience and quality of life measures compared to Daivobet(R) Gel.
- Submission of Marketing Authorization Application in EU is planned for H1 2020.
Copenhagen, December 18th, 2019 - MC2 Therapeutics, an emerging pharmaceutical company focused on novel PAD(TM) Technology based topical therapies for chronic inflammatory conditions, today announced that its EU Phase 3 trial (n=490) on the company's investigational drug, Wynzora(TM) Cream, met its primary endpoint and that a Marketing Authorization Application (MAA) is now in preparation for H1 2020.
Wynzora(TM) Cream (calcipotriene and betamethasone dipropionate, 0.005%/0.064% w/w) was studied in adult patients with plaque psoriasis and compared to Daivobet(R) Gel (marketed in the US as Taclonex(R) Topical Suspension) and cream vehicle.
Top-line data demonstrate that:
Wynzora(TM) Cream has statistically significantly greater treatment efficacy compared to Daivobet(R) Gel
- PGA treatment success defined as a minimum two-point decrease in the Physician Global Assessment (PGA) score to clear or almost clear disease at Week 8 (p<0.05). The PGA treatment success for Wynzora(TM) Cream was 52%.
- Change from Baseline in mPASI to Week 8 (p<0.05, per protocol analysis set). The change from Baseline in mPASI was 68% for Wynzora(TM) Cream and statistically significantly better than Daivobet(R) Gel already at Week 4 (p<0.001).
Wynzora(TM) Cream has statistically significantly better patient reported outcomes compared to Daivobet(R) Gel
- Patient reported treatment convenience (PTCS) at Week 4 (p<0.001) and Week 8 (p<0.0001).
- Change from Baseline in the dermatology life quality index (DLQI) at Week 4 (p<0.05) and Week 8 (p<0.05).
Wynzora(TM) Cream demonstrates a favorable safety profile
- Few drug-related adverse reactions generally of mild severity.
- No drug-related adverse reactions with a frequency >=1% in the safety data base proposed for labelling in US and EU.
"We continue to be impressed by the performance of Wynzora(TM) Cream in clinical trials. With a PGA treatment success of 52% and 68% reduction in mPASI and a very favorable safety profile, Wynzora(TM) Cream is delivering on its promise to provide high comfort to physicians and patients in treating plaque psoriasis." stated Jesper J. Lange, CEO of MC2 Therapeutics and added: "Wynzora(TM) Cream takes the treatment experience in daily routines to a new level. Our PAD(TM) Technology has enabled an aqueous cream formulation that is designed for high convenience in daily routines illustrated by the positive patient reported treatment convenience and quality of life outcomes in our Phase 3 trials. This is a key component of treatment in real life settings."
MC2 Therapeutics is seeking to upgrade the treatment experience for patients having chronic inflammatory diseases including plaque psoriasis. Enabled by PAD(TM) Technology, Wynzora(TM) Cream has been developed to provide physicians and patients high comfort on relief of psoriasis symptoms with favorable safety and convenience in daily routines. A once-daily, non-greasy product that quickly absorbs into the skin allowing patients to comfortably put on clothes, go to bed or engage in other physical and social activities within a few minutes after application.
The EU Phase 3 data is an important step in the global development of Wynzora(TM) Cream. MC2 Therapeutics recently announced FDA's acceptance of its New Drug Application on Wynzora(TM) Cream with July 20th, 2020 as the PDUFA action date.
About the Wynzora(TM) Cream Phase 3 Trial
This Phase 3, randomized, multicenter, investigator-blind, parallel-group trial evaluated the efficacy and safety of Wynzora(TM) Cream compared to Wynzora(TM) vehicle and the active comparator Daivobet(R) Gel in patients with psoriasis vulgaris. The trial enrolled 490 patients at 32 clinical centers across Germany, Poland and Czech Republic. Patients applied trial medication topically once daily for eight weeks.
Data from the trial will be presented at upcoming clinical conferences. Global development of Wynzora(TM) Cream will continue and MC2 Therapeutics plans to submit a MAA in EU in the first half of 2020.
About Wynzora(TM) Cream
Wynzora(TM) Cream is the first cream-based fixed dose combination of calcipotriene and betamethasone dipropionate for topical treatment of plaque psoriasis. Wynzora(TM) Cream is based on PAD(TM) Technology, which uniquely enables stability of both calcipotriene and betamethasone dipropionate in a convenient aqueous formulation. In the Phase 3 trials conducted at multiple sites in the US and the EU, Wynzora(TM) Cream has demonstrated a statistically significantly greater efficacy compared to Taclonex(R) Topical Suspension and Daivobet(R) gel. The unique combination of significant clinical efficacy, a favorable safety profile and high convenience of Wynzora(TM) Cream holds promise to increase treatment adherence and overall patient satisfaction in topical treatment of plaque psoriasis in the real-world setting.
About MC2 Therapeutics A/S
MC2 Therapeutics is a privately held pharmaceutical company focused on topical therapies for chronic inflammatory conditions. Using its proprietary PAD(TM) Technology MC2 Therapeutics is developing a pipeline of novel innovative topical therapies designed for unique patient experiences.
For additional information on MC2 Therapeutics Group, please visit www.mc2therapeutics.com
Jesper J. Lange, CEO will present at Dermatology Summit, San Francisco, January 12th, 2020
JP Morgan Healthcare Conference, San Francisco, January 13th - 16th, 2020
Winter Clinical, Hawaii, January 16th - 19th, 2020
AAD, Denver, March 20th - 24th, 2020
MC2 Therapeutics A/S
Lonni Goltermann, EA to the CEO // +45 2018 1111 or firstname.lastname@example.org
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