BioCryst Pharmaceuticals has initiated the first Phase II study to evaluate BCX-4208/R3421 for the treatment of moderate to severe psoriasis. This clinical trial is being led by Roche.
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BCX-4208 is an orally available small molecule inhibitor of purine nucleoside phosphorylase (PNP), 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.
“BCX-4208 is the lead compound in our second generation PNP inhibitor program and the initiation of this trial represents a significant step towards demonstrating proof-of-concept with this promising approach in important disease areas,” commented Jon P. Stonehouse, CEO of BioCryst.
Phase I single ascending dose and multiple ascending dose trials in healthy volunteers were successfully completed in 2006. The Phase II study is a double-blind, placebo-controlled randomized trial, comprised of three arms, each enrolling 20 patients for a total of 60 patients with moderate to severe psoriasis. Two arms will receive active drug in different dosage strengths, while patients in the third arm will receive placebo. Patients in all three arms will be dosed once daily for six weeks. The study will be conducted at multiple centers across the US.
In 2005, BioCryst announced a partnership with Roche for the development and commercialization of BCX-4208 for transplantation and autoimmune diseases. Roche holds exclusive worldwide rights to BCX-4208 and BioCryst retains co-promotion rights in the US for several indications.