Positive Topline Results Announced for Oral Orismilast for Treatment of Psoriasis

Union therapeutics A/S, a privately held, multi-asset, clinical stage, pharmaceutical development company, has announced the results of an IASOS Phase 2b dose-ranging study evaluating the safety and efficacy of oral orismilast in patients with moderate to severe psoriasis.¹

The Phase 2b study was a randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study targeting 200 patients at clinical sites in the US, the UK, Germany, and Poland.

Data showed that all active arms of oral orismilast achieved the primary endpoint of percentage change in Psoriasis Activity and Severity Index (PASI) from baseline to week 16 measured against placebo, with statistical significance reached already at the first time point after 4 weeks of treatment. Results support the target product profile of a best-in-class next-generation phosphodiesterase type-4 (PDE4) inhibitor and confirm the well-established favorable safety profile

Orismilast operates early in the inflammation cascade, inducing a broad range of anti-inflammatory effects across multiple cytokines involved in many dermatological and immunological diseases. It holds the potential to become a safe and efficacious oral treatment for many immunological diseases, and UNION is currently developing oral orismilast for the treatment of atopic dermatitis, psoriasis and hidradenitis suppurativa. UNION plans to present topline data at an upcoming dermatology conference.

Psoriasis is a chronic, systemic, inflammatory skin disease that is diagnosed in an estimated 8 million patients in the US. Plaque psoriasis is the most common variant and can appear on any area of the body, but most often presents on the scalp, knees, elbows, trunk, and limbs. Patients with psoriasis experience substantial morbidity and increased rates of inflammatory arthritis, cardiometabolic diseases, and mental health disorders.

Reference

1. Press Release: UNION therapeutics announces enrollment of first patient in the IASOS Phase 2b study of oral orismilast in psoriasis patients. January 9, 2023. Accessed January 9, 2023. 2022. https://uniontherapeutics.com/union-therapeutics-announces-enrollment-of-first-patient-in-the-iasos-phase-2b-study-of-oral-orismilast-in-psoriasis-patients-2/