The US Food and Drug Administration (FDA) has granted Fast Track designation to Union Therapeutics’ oral orismilast for the treatment of moderate to severe atopic dermatitis (AD).
Orismilast is a next generation PDE4 inhibitor with broad anti-inflammatory properties also in development for the treatment of psoriasis and hidradenitis suppurativa (HS).
The FDA's Fast Track designation is intended to facilitate the development and review of drug candidates that treat serious conditions and address an unmet medical need. A drug candidate that receives Fast Track designation is eligible for more frequent interaction with the FDA to discuss the drug candidate's development plan as well as eligibility for rolling review and priority review.
"We are very pleased to receive this Fast Track designation for oral orismilast and look forward to working closely with the FDA. We believe that oral orismilast holds great promise and has the potential to become an efficacious treatment option for patients who need systemic therapy for atopic dermatitis without the safety issues associated with oral corticosteroids," says Kim Kjøller, Chief Executive Offer of UNION therapeutics, in a news release.
Two challenges exist for the currently commercialized oral PDE4 inhibitors: their overall efficacy within existing indications tends to be moderate and they are limited by gastrointestinal side effects which worsens with dose increase. This represents challenges for an effective PDE4 therapy. Orismilast was selected to improve anti-inflammatory potency whilst minimizing gastrointestinal side effects. Additionally, orismilast has demonstrated clinical proof-of-concept in both psoriasis and AD patients.
Union Therapeutics has two product candidates with orismilast in its clinical stage pipeline: UNI50001, an oral PDE4 inhibitor currently investigated for the treatment of psoriasis, AD and HS; and UNI50002, a non-steroidal topical PDE4 inhibitor currently investigated for the treatment of AD.
"Atopic dermatitis is one of the most common chronic skin diseases worldwide. Despite the recent advancements in the treatment of atopic dermatitis, there is still a high unmet need in terms of safe and efficacious oral treatments that can be used before biologics,” says Jonathan Silverberg, MD, PhD, MPH. "It is encouraging to see that FDA recognizes the potential of orismilast in atopic dermatitis and grants it fast track designation, which would bring orismilast one step closer to patients."
