UNION therapeutics to present orismilast Phase 2b results in atopic dermatitis as a late-breaking oral presentation at the EADV Congress 2024

• ADESOS Phase 2b results with orismilast in atopic dermatitis (AD) selected as late-breaking oral presentation
• Additionally, two posters on data from the pioneering use of tape stripping for biomarker analysis in the ADESOS study and additional ADESOS Phase 2b results
• Orismilast is a next generation, high potency PDE4 B/D selective inhibitor with reported positive results from a Phase 2b study in psoriasis and Phase 2, IIT, study in hidradenitis suppurativa (HS); orismilast is currently being evaluated in an ongoing Phase 2, IIT study in ulcerative colitis (UC)
• UNION plan to progress orismilast to Phase 3 development in AD

Hellerup, Denmark, September 20, 2024 – UNION therapeutics A/S (UNION), a privately held, clinical stage, pharmaceutical development company focused on immunology, today announced ADESOS Phase 2b results selected as a late-breaking oral presentation at the European Academy of Dermatology and Venerology (EADV) Congress 2024 on September 25-28, 2024, in Amsterdam, Holland. New data from the ADESOS Phase 2b study of orismilast in AD will be presented by Prof. Dr. Eric Simpson.

The efficacy and safety results of orismilast from the Phase 2b ADESOS trial will also be presented as an poster. Additionally, one poster on the molecular effects in the skin of AD patients after oral orismilast treatment will be presented.

“Despite the current developments of new treatments in AD, there is a clear need for safe and efficacious oral treatments. Impact on patients’ experience of itch and pain along with lesional improvements are key to determine the relevance of a treatment”, says Prof. Dr. Eric Simpson. “I am excited to present the results from the Phase 2b ADESOS study at the EADV Congress 2024, showing that orismilast offers the promise as a novel treatment option in AD with early impact on patients’ burden of disease, including significant itch reduction from 1 week of treatment.”

“We are pleased that the Phase 2b results from the ADESOS study have been selected as a late-breaking oral presentation at the EADV Congress 2024”, adds Kim Kjøller, Co-CEO of UNION. “Additionally, we appreciate the opportunity to present two posters on ADESOS Phase 2b results and the molecular effects in the skin after treatment with orismilast, following the pioneering use of tape strips to analyze the effect on relevant disease biomarkers. We look forward to being at the conference and discuss the results with leading experts within the field as we are progressing orismilast in Phase 3 development in atopic dermatitis.”

Presentation details for the late-breaking presentation

Presentation: Orismilast efficacy in adults with moderate-to-severe atopic dermatitis in a phase 2b trial: early impact on itch and patient-reported outcomes

Session code: D1T01.1

Presenter: Prof. Dr. Eric Simpson, Professor of Dermatology, School of Medicine, Frances J. Storrs, M.D. Medical Dermatology Professor, Dermatology, School of Medicine

Date and time: Wednesday September 25, 2024, at 2:30-2:45 PM GMT

Details for the posters

Poster title: Molecular effects in the skin of atopic dermatitis after oral treatment with orismilast

ID: 5905

Poster number: P3569

Poster title: Efficacy and safety of orismilast, a potent PDE4B/D inhibitor, in adults with moderate-to-severe atopic dermatitis: a Phase 2b randomized, double-blinded, placebo-controlled clinical trial (ADESOS)

ID: 4256

Poster number: P0598

About orismilast

Orismilast is a next generation, high potency PDE4 inhibitor targeting the PDE4B/D subtypes linked to inflammation, demonstrating potent inhibition of Th1, Th2 and Th17 pathways. It acts early in the inflammation cascade, inducing a broad range of anti-inflammatory effects across multiple cytokines involved in many dermatological and immunological diseases.1)

UNION is developing orismilast as an oral treatment across immunology. Based on the well-known safety profile of the PDE4 class, initially targeting best-in-class or first-in-class positions in atopic dermatitis (AD), hidradenitis suppurativa (HS), psoriasis and ulcerative colitis (UC).

The FDA has cleared UNION’s Investigational New Drug (IND) application for orismilast and granted Fast Track designation for orismilast for the treatment of moderate to severe AD as well as for the treatment of moderate to severe HS.

Contacts

Morten Boesen, Chief Financial Officer, UNION therapeutics A/S

+45 2381 5487

morten.boesen@uniontherapeutics.com

Sarah Toft-Jørgensen, Director of Communications and IR, UNION therapeutics A/S

+45 5385 3044

sarah.toft-joergensen@uniontherapeutics.com

About UNION therapeutics

UNION therapeutics is a privately held, clinical stage, pharmaceutical development company focused on immunology. UNION’s lead asset is orismilast, a next generation, high potency PDE4 B/D inhibitor, for a range of immunological diseases e.g., atopic dermatitis (AD) and hidradenitis suppurativa. Orismilast holds the potential to become the first safe oral treatment in AD. UNION is headquartered in Hellerup, Denmark, and led by an international team combining biotech entrepreneurs and seasoned pharma executives, with a track record of developing and launching more than fifteen marketed drugs. Read more at www.uniontherapeutics.com