MC2 Therapeutics Announces Submission of New Drug Application to US FDA for Wynzora™ Cream (Calcipotriene 0.005% and Betamethasone Dipropionate 0.064%) for Treatment of Plaque Psoriasis

COPENHAGEN, Denmark–(BUSINESS WIRE)–MC2 Therapeutics, a late clinical-stage pharmaceutical company focused on novel PAD™ Technology-based topical therapies for chronic inflammatory conditions, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval for Wynzora™ Cream (calcipotriene 0.005% and betamethasone dipropionate 0.064%) for the treatment of plaque psoriasis.

Using its proprietary PAD™ Technology platform, MC2 Therapeutics developed Wynzora™ Cream, a PAD™ Cream incorporating a fixed dose combination of calcipotriene and betamethasone dipropionate, to address a substantiated unmet need among patients with plaque psoriasis who are seeking a topical therapy that is convenient to use as part of their daily routine without compromising efficacy and safety. In a head-to-head Phase 3 clinical trial, Wynzora™ Cream has demonstrated statistically significant greater efficacy and superior treatment convenience compared to its vehicle and Taclonex^® Topical Suspension.

“We are thrilled to have reached this important milestone in our efforts to introduce a new treatment experience to patients,” says Jesper J. Lange, CEO of MC2 Therapeutics A/S. “When we – several years ago – decided to improve the well-established combination of calcipotriene and betamethasone dipropionate by formulating them in a PAD™ Cream we knew that we were setting a very high bar in our ambition to respond to the needs of patients. With Wynzora™ Cream we believe that we have responded beyond expectations setting a new standard in daily routines for patients suffering from plaque psoriasis.”

MC2 Therapeutics is also using its PAD™ Technology-based formulations for other anti-inflammatory drug candidates in relevant indications such as atopic dermatitis, uremic pruritus and dry eye. The Company is also planning to launch an innovative new line of PAD™ Cream-based consumer healthcare products designed for dry, itchy and sensitive skin.

“Patients with chronic inflammatory skin conditions and sensitive skin are also in need of moisturizers, barrier creams, sanitizers, sunscreens, creams for itchy skin etc. Our ambition is to make the new PAD™ experience available to all people with sensitive skin or chronic inflammatory conditions,” Lange said. “PAD™ Technology enables us to make PAD™ Creams with multifold less surfactants compared to conventional creams and lotions thereby optimizing tolerability on sensitive skin.”

About Wynzora™ Cream

Wynzora^™ Cream is the first cream-based fixed dose combination of calcipotriene and betamethasone dipropionate for topical treatment of plaque psoriasis. Wynzora™ Cream is based on PAD™ Technology, which uniquely enables stability of both calcipotriene and betamethasone dipropionate in a convenient aqueous formulation. In a Phase 3 trial conducted at multiple US sites, Wynzora™ Cream demonstrated a statistically significant greater efficacy compared to Taclonex^® Topical Suspension for all endpoints related to physician global assessment (PGA) and PASI. Patients reported superior treatment convenience of Wynzora™ Cream over Taclonex^® Topical Suspension, and no adverse reaction was reported in more than 1% of patients treated with Wynzora™ Cream. The unique combination of favorable safety profile, significant clinical efficacy and high convenience of Wynzora™ 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

MC2 Therapeutics is a privately held pharmaceutical company focused on topical therapies for chronic inflammatory conditions. Using its proprietary PAD™ Technology – a unique oil-in-water dispersion – 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

Next events

Fall Clinical, Las Vegas, October 17^th-20^th October 2019

Jefferies Healthcare Conference, London, November 20^th-21^st 2019

Dermatology Summit, San Francisco, January 12^th 2020

JP Morgan Healthcare Conference, San Francisco, 13^th -16^th January 2020

Winter Clinical, Hawaii, January 16^th–19^th 2020

Contacts

MC2 Therapeutics A/S
Lonni Goltermann, EA to the CEO // +45 2018 1111 or [email protected]