UNION therapeutics A/S (UNION), a privately-held, multi-asset, clinical stage, pharmaceutical development company focused on immunology and infectious diseases, announces that the first patient has been enrolled in ADESOS, a Phase 2b dose-finding study evaluating the safety and efficacy of orismilast MR tablet in adult patients with moderate to severe AD. The purpose of the study is to identify the appropriate dose regimen for Phase 3 studies.
In November 2021, the US Food and Drug Administration (FDA) granted Fast Track designation to orismilast MR tablet for the treatment of moderate to severe AD. The FDA’s Fast Track designation is intended to facilitate the development and review of drug candidates that treat serious conditions and address an unmet medical need. This underscores the need for new treatment options with potential to fulfil the unmet medical needs for people affected by AD.
UNION has recently investigated the inhibitory effect of orismilast on the secretion of various inflammatory cytokines in human peripheral blood mononuclear cells in vitro. Orismilast underlined its potential in AD, psoriasis, and HS by demonstrating broad anti-inflammatory properties with potent inhibition of the main cytokines involved in these indications1). Data from the study will be presented at the 31st EADV (European Academy of Dermatology and Venereology) Congress at 7-11 September 2022.
Kim Kjøller, Chief Executive Officer of UNION therapeutics said:
“Orismilast modified release tablet holds the potential to become a first-in-class treatment and become an efficacious treatment option for patients who need systemic therapy for atopic dermatitis. The initiation of the ADESOS study marks an important advancement of UNION’s pipeline.”
Jonathan Silverberg, MD, PhD, MPH, Associate Professor of Dermatology at The George Washington University School of Medicine and Health Sciences and Signatory Investigator for ADESOS adds:
“AD is one of the most common chronic skin diseases worldwide. Despite recent advancements in the treatment of AD, there are still many unmet needs for safe and effective oral treatments. Orismilast modified release tablet has the potential to be an effective and patient-friendly treatment option in AD.”
