UNION therapeutics has announced that 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.
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.
“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,” says Kim Kjøller, Chief Executive Officer of UNION therapeutics.
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.
Photo of Kim Kjøller: LEO Pharma