Shares of BioCryst Pharmaceuticals ($BCRX) bumped up 12% this morning after the biotech unveiled a set of positive top-line data for its mid-stage gout drug. In a 12-week Phase IIb study of BCX4208, four doses of the treatment combined with allopurinol registered positive results ranging from 33% to 49% compared to an 18% mark for the placebo arm.
All but one of the doses tested achieved a statistically significant response over the placebo. Investigators recruited 279 patients for the study who had already failed to respond adequately to allopurinol alone. BioCryst reported that two patients were discontinued from the 20 mg group, with 8 dropping out from the 40 mg group "due to pre-specified stopping rules based on CD4+ cell counts."
BioCryst’s claimed success, though, failed to impress TheStreet’s Adam Feuerstein. The developer’s big problem, he writes, is that Ardea BioScience’s gout drug--RDEA594--posted much better data in Phase II, with patients on the drug reporting response rates ranging up to 80%. That leaves BioCryst wasting shareholders’ money on a development program, he adds scornfully.
"These positive results in 2nd line treatment are consistent with findings from our prior first-line combination study, and reinforce BCX4208's potential to safely address the unmet medical need for new treatment options that help gout patients reach their therapeutic goal," said Dr. William P. Sheridan, the biotech's chief medical officer. "We expect to report 6-month results from the ongoing extension study in early 2012, which will provide additional insight into BCX4208's safety and efficacy profile. We are on track to conclude this Phase II program during the first half of next year and we look forward to discussing the results in more detail with regulatory authorities and potential partners."
BioCryst is perhaps best known for its flu drug peramivir, which was the focus of considerable attention during the recent swine flu pandemic. But the biotech has two other late-stage programs under way as well, keeping it in the eye of the biotech investment community.