Is BCRX saying 4208 is dead or higher doses for longer durations may be required? ... or that they'll check it out for Gout or other autoimmune stuff, not Psoriasis?
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BioCryst Reports Results From BCX-4208 Phase IIa Trial in Subjects With Psoriasis
prnews
Data are Consistent With Previously Announced Interim Findings
BIRMINGHAM, Ala., Sept. 4 /PRNewswire-FirstCall/ -- BioCryst Pharmaceuticals (Nasdaq: BCRX) today announced results from the completed Phase IIa trial of BCX-4208 in patients with moderate to severe plaque psoriasis. Consistent with interim findings reported in May 2008, this study of BCX-4208, a potent, rationally designed, orally available purine nucleoside phosphorylase (PNP) inhibitor, met its primary objectives of safety and tolerability. In addition, BCX-4208 displayed dose-dependent reductions in peripheral blood lymphocyte counts, including subsets measuring B cells (CD20), total T cells (CD3), T helper cells (CD4) and T suppressor/cytotoxic cells (CD8).
Further, plasma levels of BCX-4208 increased with dose, and plasma uric acid levels showed dose-related reductions with BCX-4208. In addition, consistent with interim results, no evidence of clinical efficacy, a secondary objective, was observed in psoriasis patients with the doses and duration of administration tested. The Phase IIa safety and pharmacodynamic data have been submitted for presentation at an upcoming medical meeting.
"The promising results of this study, the largest and most detailed investigation of BCX-4208 to date, suggest that further investigation is warranted," stated William Sheridan, MB BS, Chief Medical Officer of BioCryst. "The pharmacokinetic and pharmacodynamic results extend our knowledge base of PNP inhibition in the clinic, confirm the specificity of the effect and suggest that BCX-4208 may have utility in diseases dependent on T cells, B cells, or uric acid."
The Phase IIa study was a randomized, double-blind, placebo-controlled, dose-ranging trial, which enrolled 66 patients with moderate to severe plaque psoriasis. BCX-4208 was administered once a day for six weeks at a dose of either 20 mg or 120 mg. Patients were monitored for at least four weeks following treatment. The primary objectives of the study were safety and tolerability. Secondary objectives included pharmacodynamic and pharmacokinetic measures, and clinical response.
In the Phase IIa trial, BCX-4208 was generally safe and well-tolerated at doses up to 120 mg daily. Most adverse events reported were considered mild or moderate, and low in frequency. No opportunistic infections were observed. In addition, detailed laboratory and clinical monitoring did not indicate any patterns suggestive of off-target adverse findings.
Earlier this year, following review of a planned interim analysis of the Phase IIa trial, Roche terminated its license agreement for the development of BCX-4208 for autoimmune diseases and transplant. As a result, BioCryst regained worldwide rights to BCX-4208. Roche and BioCryst agreed to complete the Phase IIa trial.
About BCX-4208
BCX-4208 is a potent, rationally-designed, orally available small molecule inhibitor of purine nucleoside phosphorylase (PNP), a purine salvage pathway enzyme that is essential for the proliferation of activated T cells. BioCryst holds worldwide rights to BCX-4208. |
