First Patient Enrolled in Phase 2b Study of Oral Orismilast in Psoriasis

January 5, 2022

Union Therapeutics' orismilast is a next generation PDE4 inhibitor with broad anti-inflammatory properties that is also in development for the treatment of HS and AD.

The first patient has been enrolled in IASOS, a Phase 2b dose-ranging study evaluating the safety and efficacy of oral orismilast in patients with moderate to severe psoriasis, according to UNION therapeutics.

Orismilast is a next generation PDE4 inhibitor with broad anti-inflammatory properties also in development for the treatment of hidradenitis suppurativa (HS) and atopic dermatitis (AD).

In November 2020, the US Food and Drug Administration (FDA) approved UNION's Investigational New Drug Program (IND) for advancing oral orismilast into a Phase 2b trial in patients with moderate to severe psoriasis. UNION has now launched the IASOS Phase 2b study with the purpose of identifying the appropriate dose-regimen for Phase 3 studies.

"Psoriasis is one of the most common chronic inflammatory skin diseases in the world. Even though there are many biologics approved for the treatment of psoriasis, there are still limited oral treatments that are efficacious, can be used long term and do not require screening before initiation and during use,” says Prof. Richard Warren, MD, PhD, The University of Manchester and Consultant Dermatologist, Salford Royal NHS Foundation Trust, Senior Investigator of the Phase 2b study, in a news release.  “Oral orismilast has the potential to become an efficacious and patient-friendly treatment option for patients with psoriasis and we are pleased to have enrolled the first patient in this Phase 2b study."

"Orismilast holds the potential to be a best-in-class treatment and game-changer for psoriasis patients. With the first patient enrolled in the Phase 2b study in psoriasis, we are one step closer to offering psoriasis patients a novel oral treatment option," adds Kim Kjøller, Chief Executive Officer of UNION therapeutics.

About the IASOS Phase 2b study

The Phase 2b study is a randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to evaluate the efficacy and safety of orismilast in patients with moderate to severe plaque psoriasis. The primary objective is to evaluate the efficacy and safety of a modified release orismilast tablet versus placebo. The study targets to include 200 patients who will be randomized to three active doses and placebo administered twice daily. The study will be conducted in approximately 40 centers in Europe and North America. The overall aim of the study is to identify the appropriate dose-regimen for Phase 3 studies with oral orismilast in psoriasis.

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