BioCryst Successfully Completes Trial With Oral BCX-4208 for Psoriasis

BioCryst Pharmaceuticals has announced that BCX-4208 has successfully completed a Phase I, placebo-controlled, single ascending dose, pharmacokinetic and safety trial involving 84 healthy volunteers.

The study, which evaluated the pharmacokinetic profile for this oral formulation, measured BCX-4208 inhibition of the target enzyme purine nucleoside phosphorylase (PNP), and included detailed safety evaluations of renal and liver function, hematologic parameters, immunological markers and cardiac function as measured through continuous electrocardiogram monitoring, including detailed QTc evaluations.

Results from this Phase I study indicate that single doses of BCX-4208 ranging from 0.5 mg/kg to 3 mg/kg were well-tolerated among the broad spectrum of safety parameters being monitored. Additionally, BCX-4208 achieved a dose-related inhibition of PNP, which effectively increases the serum level of deoxyguanosine that is necessary for selective suppression of T-cell activation.

Based on these positive results, BioCryst intends to initiate a randomized, double-blind, escalating, multidose Phase I trial with BCX-4208 to further evaluate its safety profile and pharmacokinetics in approximately 60 healthy volunteers beginning in the second quarter of 2005.