Union begins enrollment in phase 2b oral orismilast psoriasis trial

The first patient has been enrolled in a phase 2b study oral orismilast for the treatment of moderate to severe psoriasis, Union therapeutics A/S announced in a press release.

A phosphodiesterase type-4 (PDE4) inhibitor, orismilast is being developed as a modified release tablet for the treatment of many inflammatory dermatologic diseases including psoriasis, hidradenitis suppurativa and atopic dermatitis.

The randomized, double-blind, placebo-controlled, parallel-group, dose-ranging phase 2b IASOS study will evaluate the safety and efficacy of the drug compared with placebo in 200 patients in three active dose groups.

The study aims to identify the appropriate dose 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,” Richard Warren, MD, PhD, senior investigator on the study, said in the press 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.”

The FDA approved an Investigational New Drug program for oral orismilast in November 2020 and a fast track designation was granted in November 2021.