BioCryst/Roche's psoriasis drug enters Ph II

Alabama, USA-based BioCryst Pharmaceuticals and Swiss drug major Roche have initiated the first Phase II study to evaluate their co-developed drug candidate BCX-4208/R3421. This clinical trial, led by Roche, is designed to evaluate BCX-4208 in patients with moderate-to-severe plaque psoriasis.

The orally-available small-molecule inhibitor of purine nucleoside phosphorylase (PNP) is an enzyme that is essential for the proliferation of activated T cells. With its novel mechanism of action, BCX- 4208 has the potential to address unmet medical needs across a broad spectrum of autoimmune diseases as well as in the area of acute transplant rejection, the firm stated.

The Phase I single and multiple ascending dose trials in healthy volunteers were successfully completed in 2006. The new Phase II study is a double-blind, placebo-controlled randomized trial, comprised of three arms, each enrolling 20 patients for a total of 60 subjects with moderate-to-severe psoriasis. Two arms will receive active drug in different dosage strengths, while patients in the third group will be given placebo. Patients in all three arms will be dosed once daily for six weeks.