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UNION initiates Phase 2b Dose-Ranging Study Evaluating ATx201 OINTMENT in Patients with Mild-to-Moderate Atopic Dermatitis

  • Multi-national, double-blinded, and vehicle-controlled study
  • Study expected to enroll approximately 210 patients
  • Topline results expected in Q3 2020

COPENHAGEN, Denmark: UNION therapeutics A/S (“UNION”), a privately held clinical stage pharmaceutical company dedicated to the discovery and development of novel medicines for patients with unmet medical needs in inflammatory and infectious diseases, today announced the First Patient First Visit in a Phase 2b dose-ranging study evaluating the safety and efficacy of ATx201 OINTMENT in adult and adolescent patients with mild-to-moderate atopic dermatitis.

“Atopic dermatitis is a debilitating disease affecting the lives of millions of patients and their families. Despite it being the most common form of eczema, the current treatments continue to be characterized by a trade-off between efficacy and safety. We hope to be able to break this trade-off with ATx201 OINTMENT, and believe it could become a new mainstay treatment for atopic dermatitis”, states Rasmus Toft-Kehler, CEO of UNION.

“The mechanism of action of ATx201 is novel, making it a new class of treatment for inflammatory diseases and differentiating it from the products on the market as well as in development. Our initial clinical and preclinical studies have generated support for the mechanism of action to be well suited for treatment of atopic dermatitis. We are therefore very excited to initiate this study as an important step towards helping the many patients with atopic dermatitis”, states Professor Morten Sommer, Chief Scientific Officer of UNION.

“Despite positive advancements in recent years, the medical need for new treatment solutions for atopic dermatitis is very significant, and I look forward to seeing the data for ATx201”, says Jacob Thyssen, Clinical Professor in Dermatology at Copenhagen University and Herlev-Gentofte Hospital, and Principal Investigator in Denmark on the study.

ATx201 Phase 2b study
The randomized, double-blinded, vehicle-controlled, parallel group Phase 2b study is designed to evaluate the safety and efficacy of ATx201 OINTMENT as a monotherapy and to establish the dosing regimen for a potential Phase 3 program in patients with mild-to-moderate atopic dermatitis. The study is expected to enroll approximately 210 patients aged 12 years and older with mild-to-moderate atopic dermatitis. The study is conducted at sites in three countries in the European Union. The study will evaluate two active treatment groups compared to a placebo (vehicle) treatment group for 6 weeks, with patients randomized in a 1:1:1 fashion:

  • Treatment group 1: Twice-daily treatment with 4% ATx201 OINTMENT
  • Treatment group 2: Twice-daily treatment with 7% ATx201 OINTMENT
  • Treatment group 3: Twice-daily treatment with placebo (vehicle)

The primary end-point of the study is the mean change in Eczema Area Severity Index (EASI) from baseline to week 6. Secondary end-points include a number of other efficacy measures as well as patient reported outcomes. Topline data is expected in Q3 2020.

About UNION:
UNION is a privately held, clinical stage, pharmaceutical company dedicated to the development of novel treatments for inflammatory and infectious diseases. The company is working of a versatile new mode-of-action chemistry platform. The leadership team of UNION has successfully developed multiple approved drugs on the market. UNION is headquartered in Copenhagen (Denmark) and managed by a global team across Europe and USA.

This press release contains forward-looking statements. Forward-looking statements are statements that are not historical facts and can be identified by words such as committed, will, steps, may, can, portfolio, planned, advancing, look forward, expected, or similar words. These forward-looking statements are based upon current expectations, estimates, believed potentials and can, therefore, involve risks and uncertainties. Many of these risks and uncertainties can be difficult to predict and could be out of the control of UNION therapeutics A/S. We may not actually achieve our intended plans, and you should not place undue reliance on these forward-looking statements.

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