RESEARCH TRIANGLE PARK, NC (
(BCRX - Get Report)
new gout drug data released Wednesday are underwhelming and don't come close to matching the efficacy of a competing gout drug from
Like its protracted and largely wasted effort to develop a new flu drug peramivir, Biocryst also appears to be squandering shareholder money with the gout drug BCX4208.
Biocryst's phase II study enrolled 279 gout patients who were not adequately controlled while taking allopurinol, an older medicine that is considered the current standard of care. The gout patients were randomized among four once-daily doses of BCX4208 or a placebo. All the patients continued to take allopurinol.
After 12 weeks of treatment, the gout patients treated with BCX4208 plus allopurinol had response rates ranging from 33% to 49% compared to 18% for patients treated with a placebo plus allopurinol. The difference in response rates was statistically significant in all but one of the BCX4028 doses tested.
The results were good enough for Biocryst to declare victory and a positive study, but the BCX4028 data are hardly clinically relevant compared to the drug's main competition.
Ardea Bioscience ran a similar phase II study in the same type of allopurinol-resistant gout patient for its experimental drug lesinurad (RDEA594.) The results presented this past spring demonstrated lesinurad response rates in the 70-80% range compared to 28% for placebo.
Biocryst's BCX4208 data look even worse when you consider that the study's best 49% response rate in the highest 40 mg dose cohort also caused significant toxicity. Eight patients treated with the 40 mg dose of BCX4208 had to discontinue the study because the drug caused an unsafe drop in their CD4 immune cells. Two patients in the 20 mg BCX4208 dose cohort also had to drop out of the study for the same reason.
Gout is caused by elevated uric acid levels in the bloodstream that, in turn, causes painful swelling and pain in joints. Gout drugs are designed to lower uric acid levels.
Ardea plans to begin phase III studies of lesinurad in gout before the end of the year. Biocryst is still waiting for additional data from phase II studies expected next year.
Tell me again why investors should place any value in a Biocryst gout drug that is late and relatively ineffective?
--Written by Adam Feuerstein in Boston.
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