BioCryst Pharmaceuticals Presents New BCX4208 Gout Data at the 2011 ACR/ARHP Annual Scientific Meeting
BioCryst to host a conference call & webcast today at
This Phase 2b study randomized 279 patients to five study arms: BCX4208 at doses of 5 mg, 10 mg, 20 mg, 40 mg and placebo, administered once-daily for 12-weeks. Allopurinol 300 mg once-daily was administered in all study arms. The primary study endpoint was the proportion of patients with sUA <6 mg/dL at day 85. The mean baseline sUA for the randomized population was 6.9 mg/dL.
The primary endpoint of the study was successfully achieved. When added to allopurinol 300 mg, BCX4208 was superior to allopurinol plus placebo (p=0.009 overall). BCX4208 doses evaluated in the study showed response rates ranging from 33% to 49%, approximately doubling the proportion of patients reaching goal on placebo (18%). BCX4208 added to allopurinol was generally safe and well-tolerated at all doses studied.
"This important study demonstrates that low doses of BCX4208 combined
with allopurinol safely and significantly increase the proportion of
patients reaching therapeutic goal compared to 300 mg allopurinol, the
most commonly prescribed dose in the U.S. The study population was
representative of the general gout population, and included patients
with mild renal impairment, kidney stones and other co-morbidities,"
said lead investigator for the study,
The frequency and types of adverse events, including infections, were similar between the groups treated with BCX4208 and placebo. No opportunistic or unusual infections were reported in either the BCX4208 treated groups or placebo. A dose-dependent decrease in lymphocytes was observed, which reached a plateau between day 57 and 85 for patients still remaining in the study. The frequency of confirmed gout flares was low, ranging from 5% to 11% for BCX4208 doses combined with allopurinol, compared to 5% for placebo plus allopurinol.
BioCryst also presented results from other BCX4208 clinical and
pre-clinical studies at a poster session on
Copies of the abstracts are available online through the ACR website at www.rheumatology.org. In accordance with the conference's embargo policy, the oral presentation and posters will be uploaded to the BioCryst website after completion of the sessions. Please refer to the Company's BCX4208 publications page.
Conference Call and Webcast
Separate from the Scientific Meeting, BioCryst will host a conference
call and webcast today at
Gout is a chronic inflammatory arthritis caused by monosodium urate crystal deposits in joints and the kidneys resulting from elevated serum uric acid (sUA) levels in the blood, a condition known as hyperuricemia. The consequences of gout may include intense, painful flares affecting one or more joints, impaired kidney function and joint destruction. Gout continues to grow in prevalence and severity, affecting over 17 million people in major markets, including 8.3 million in the U.S. A majority of gout patients are also treated to manage other chronic conditions, including hypertension, diabetes and/or high cholesterol. Decreasing sUA to the recommended level (less than 6 mg/dL) can reduce the risk of gout attacks over the long-term. A minority of patients treated with the current standard of care, allopurinol, achieve this therapeutic goal. There is a need for new therapies that effectively and safely get a larger portion of gout suffers to goal without the risk of drug-drug interactions. More information regarding gout and hyperuricemia is available on the CDC website at www.cdc.gov/arthritis/basics/gout.htm.
BCX4208 is a novel enzyme inhibitor with the potential for once-a-day oral dosing suitable for chronic administration to treat gout. It acts upstream of xanthine oxidase in the purine metabolism pathway to reduce sUA in patients with gout and has a mechanism of action that complements xanthine oxidase inhibitors, such as allopurinol and febuxostat, in reducing uric acid production. With its unique mechanism of action, clinical activity and safety in clinical studies to date, BCX4208 is nearing the end of Phase 2 development as an add-on therapy to xanthine oxidase inhibitors to address unmet medical needs in patients with gout. To date, BCX4208 has been studied in over 500 subjects in clinical trials.
This press release contains forward-looking statements, including
statements regarding future results, performance or achievements. These
statements involve known and unknown risks, uncertainties and other
factors which may cause our actual results, performance or achievements
to be materially different from any future results, performances or
achievements expressed or implied by the forward-looking statements.
These statements reflect our current views with respect to future events
and are based on assumptions and subject to risks and uncertainties.
Given these uncertainties, you should not place undue reliance on these
forward-looking statements. Some of the factors that could affect the
forward-looking statements contained herein include: that there can be
no assurance that BCX4208 or our other compounds will prove effective in
future clinical studies; that development and commercialization of
BCX4208 or our other compounds may not be successful; that we or our
licensees may not be able to enroll the required number of subjects in
planned clinical trials and that such clinical trials may not be
successfully completed; that BioCryst or its licensees may not commence
as expected additional human clinical trials with BCX4208 or our other
product candidates; that BCX4208 or our other product candidates may not
receive required regulatory clearances from the
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