First Patient Enrolled in UNION Therapeutic’s Study of Orismilast MR tablet in AD

August 4, 2022

Orismilast is a next generation PDE4 inhibitor shown to be potent in inhibiting pathways important in AD

The first patient has been enrolled in ADESOS, a Phase 2b dose-finding study evaluating the safety and efficacy of UNION therapeutic’s 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 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 hidradenitis suppurativa (HS) by demonstrating broad anti-inflammatory properties with potent inhibition of the main cytokines involved in these indications. 

Data from the study will be presented at the 31st EADV (European Academy of Dermatology and Venereology) Congress at 7-11 September 2022. "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," says Kim Kjøller, Chief Executive Officer of UNION therapeutics, in a press release.

"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,” says 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. “Orismilast modified release tablet has the potential to be an effective and patient-friendly treatment option in AD."

About the ADESOS Phase 2b study

The Phase 2b study is a randomized, double-blind, placebo-controlled, parallel-group, dose-finding study to evaluate the efficacy and safety of orismilast MR tablet in patients with moderate to severe AD. The study will target 210 patients who will be randomized to three active doses (20mg, 30mg, and 40 mg) of orismilast relative to placebo administered twice daily. The study will be conducted in centers in Europe and the US.

Orismilast  is a potent next-generation phosphodiesterase type-4 (PDE4) inhibitor operating early in the inflammation cascade to induce a broad spectrum of downstream anti-inflammatory effects. 

UNION has two product candidates with orismilast in its clinical stage pipeline: Orismilast MR tablet currently investigated for the treatment of psoriasis, AD and HS; and topical orismilast with clinical proof of concept established in AD. UNION is progressing orismilast as a modified release tablet to minimize the occurrence of gastrointestinal side effects typically associated with PDE4-inhibition.

In September 2021, UNION entered into a strategic partnership and licensing agreement with Innovent Biologic for orismilast in Mainland China, Hong Kong, Macau and Taiwan.

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