BioCryst Pharmaceuticals (Nasdaq: BCRX) announced interim data from the ongoing Forodesine HCl Phase 2 program in patients with chronic lymphocytic leukemia (CLL) and data from a healthy subject pharmacokinetic and pharmacodynamic study. The CLL study will continue with an amendment to study a new dosing regimen of oral Forodesine, 200 mg twice-daily.

An interim analysis was conducted on data from an exploratory Phase 2 single-arm, open-label program in patients with CLL whose previous treatment had failed. While this analysis showed that no partial or complete responses were observed, five out of 13 patients administered 200 mg of Forodesine HCl once-daily had substantial reductions in malignant lymphocytes, and at the time of the analysis, seven patients were still on study. Forodesine HCl was generally safe and well-tolerated at the 200 mg once-daily dose.

In a parallel, healthy subject, pharmacokinetic and pharmacodynamic study, BioCryst compared the effect of seven days of 200 mg Forodesine HCl dosed once-daily with seven days of 200 mg Forodesine HCl dosed twice-daily. The study demonstrated substantially increased drug exposure and pharmacodynamic effect in subjects administered Forodesine HCl 200 mg twice-daily. Drug exposure, as measured by AUC, increased by 63 percent (P