FDA approves IND program for orismilast in plaque psoriasis

An investigational new drug program has been approved by the FDA for oral orismilast for the treatment of plaque psoriasis, Union Therapeutics announced in a press release.

This will allow orismilast, a PDE4 inhibitor, to advance to phase 2b trials in adults with moderate to severe plaque psoriasis.

“Orismilast is a next generation PDE4 inhibitor with an improved therapeutic window compared to earlier oral PDE4 inhibitors, supporting the opportunity to achieve improved efficacy while maintaining good tolerability. It holds the potential to become a best-in-class treatment and a game-changer for psoriasis patients,” Union co-founder Morten Sommer, PhD, said in the release. “Currently, oral treatment options for plaque psoriasis are limited, and many patients with moderate to severe psoriasis are receiving systemic injectable therapies. Oral orismilast would therefore offer an efficacious and patient-friendly treatment.”

Safety and efficacy of orismilast vs. placebo will be evaluated in the parallel-group, randomized, dose-ranging, double-blinded, four-armed study, which is expected to begin later this year.

“With the green light granted by the FDA to continue our clinical research, we are one step closer to offering psoriasis patients a novel, improved oral treatment option and thereby enhancing their quality of life. We confidently believe in the benefits of oral orismilast, and the IND approval marks a significant milestone in our clinical development,” Union CEO Kim Domela Kjoeller, MD, said in the release.