Phase II study results of the 300mg dose of i.m. peramivir.
-- Reductions in viral shedding and percentage of patients shedding virus
were consistent with the data seen in our previous phase II study.
-- Pharmacokinetic data in the treated population indicate that patients
achieved consistent drug levels, which were similar to those seen in
our previous well-controlled Phase I trial.
BioCryst is continuing development of a more concentrated formulation and plans to test higher doses of i.m. peramivir in the next Phase II study. The doses to be studied in Phase II will be selected based on a planned mid 2008 analysis of the ongoing Phase I study of the more concentrated formulation.
"We are encouraged by the signs of activity of i.m. peramivir and are prepared to move forward and evaluate a higher dose. The consistency seen between the results of our recent clinical trials gives us confidence that i.m. peramivir has the potential to be an effective treatment for influenza," stated Dr. Thomas J. Simon, Interim Chief Medical Officer.
BCX-4208 development update
Following review of a planned interim analysis of the ongoing Phase IIa trial of BCX-4208 in psoriasis, Roche has terminated its license agreement for the development of BCX-4208 for autoimmune diseases and transplant. As a result, BioCryst will regain worldwide rights to BCX-4208. Roche and BioCryst have agreed to complete the ongoing Phase IIa trial. The planned interim analysis showed that BCX-4208 was safe and well-tolerated; clinical efficacy was not demonstrated.
The ongoing Phase IIa trial is a randomized, double blind, placebo
controlled, dose ranging study in 66 patients with moderate to severe
plaque psoriasis. BCX-4208 is administered once a day for 6 weeks at a dose
of either 20mg or 120mg. The primary objectives of this study are to assess
the safety, tolerability, an
|SOURCE BioCryst Pharmaceuticals, Inc.|
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