UNION therapeutics completes ADESOS Phase 2b study, to present at RAVE 2024

UNION Therapeutics A/S, a clinical-stage pharmaceutical company based in Hellerup, Denmark, has announced the successful completion of the ADESOS Phase 2b trial. This trial evaluated orismilast as an oral treatment for 233 patients suffering from moderate-to-severe atopic dermatitis (AD). The results from this pivotal study have been chosen for an oral presentation at the late-breaking research sessions of the Revolutionizing Alopecia Areata, Vitiligo, and Eczema (RAVE) Conference 2024 in Chicago.

Orismilast, a next-generation, high potency PDE4 B/D selective inhibitor, has shown promising results in previous studies, including a Phase 2b trial for psoriasis and a Phase 2 trial for hidradenitis suppurativa (HS). Currently, it is also being evaluated in an ongoing IIT study for ulcerative colitis (UC). The completion of the ADESOS study represents a significant milestone as UNION progresses orismilast into Phase 3 development for atopic dermatitis.

The ADESOS Phase 2b study was a randomized, double-blind, placebo-controlled, dose-finding trial conducted across multiple centers in Europe and the United States. It included 233 patients who were assigned to receive three different doses of orismilast (20mg, 30mg, and 40mg) or a placebo, administered twice daily. The primary objective was to assess the efficacy and safety of orismilast in treating moderate-to-severe AD.

The study's success underscores the potential of orismilast as a groundbreaking oral treatment for AD, a chronic inflammatory skin disease affecting a significant portion of the population globally. AD is characterized by recurrent eczematous skin lesions and intense itching, substantially impacting the psychosocial well-being of patients and their families. Current treatment options for AD are limited, particularly in terms of safe and effective oral medications, highlighting the unmet medical need that orismilast aims to address.

Professor Jonathan Silverberg, MD, PhD, MPH, of The George Washington University School of Medicine and Health Sciences, and the Signatory Investigator for the ADESOS study, will be presenting the study results. He emphasized the importance of innovation in AD treatment, noting orismilast's potential to meet the need for a safe and effective oral therapy. His presentation is scheduled for June 10, 2024, at the RAVE Conference.

Kim Kjøller, Co-Chief Executive Officer of UNION Therapeutics, expressed satisfaction with the study's outcomes, noting that the positive results in atopic dermatitis align with previous successful trials in psoriasis and HS. He highlighted the significance of the upcoming presentation at the RAVE Conference as an opportunity to share and discuss these findings with leading experts in the field.

Orismilast's development pathway includes an End of Phase 2 meeting with the FDA to discuss advancing to Phase 3 trials for AD. The drug, known for its potent inhibition of the PDE4B/D subtypes linked to inflammation, acts early in the inflammatory cascade, affecting multiple cytokines involved in dermatological and immunological diseases. This broad anti-inflammatory action positions orismilast as a potentially first-in-class treatment for AD and HS, and best-in-class for psoriasis.

The FDA has already granted Fast Track designation for orismilast for the treatment of moderate to severe AD and HS, marking a significant step towards addressing the needs of patients suffering from these chronic conditions. The ongoing research and development efforts by UNION aim to establish orismilast as a versatile and impactful treatment option across various immunological disorders.