Corporate Banner
Satellite Banner
Scientific Community
Become a Member | Sign in
Home>News>This Article

Positive Results from Phase 2B Study into Patients with Gout

Published: Monday, January 16, 2012
Last Updated: Monday, January 16, 2012
Bookmark and Share
BioCryst Pharmaceuticals, Inc. announce results from its randomized Phase 2b study of BCX4208 added to allopurinol in patients with gout who had failed to reach the serum uric acid therapeutic goal of <6 mg/dL on allopurinol alone.

The results of this 24-week, blinded safety extension confirm that BCX4208 was generally safe and well-tolerated, and sustained serum uric acid (sUA) control over time. Patients generated healthy immune responses to a vaccine challenge at 16 or 20 weeks of BCX4208 treatment. Following the successful outcome of this 24-week analysis, BioCryst is preparing for end of Phase 2 regulatory discussions to take place in the coming months.

In the original 12-week study, 279 patients were randomized and 160 patients entered the extension phase. Patients continued their blinded, randomized therapy of BCX4208 at doses of 5 mg, 10 mg, 20 mg, 40 mg and placebo once-daily. Allopurinol 300 mg once-daily was administered in all study arms.

This longer-term safety profile of BCX4208 is consistent with the 12-week primary analysis results originally reported in October 2011. BCX4208 added to allopurinol was generally safe and well-tolerated at all doses studied, and responses to vaccines indicated healthy immune function. The types and rates of adverse events through 24 weeks, including infections, were similar between the groups treated with BCX4208 and placebo. No opportunistic or unusual infections were observed.

The previously observed lymphocyte plateau reached by 12 weeks of treatment remained unchanged in the 5 mg, 10 mg and 20 mg BCX4208 arms through 24 weeks. The 40 mg study arm met a protocol-defined cohort stopping rule based on the number of withdrawals for CD4+ cell counts, and this arm was discontinued after week 24. No patients from the placebo, 5 mg or 10 mg cohorts discontinued study drug for confirmed reductions of lymphocyte or CD4+ cell counts below certain protocol-specified thresholds; through 24 weeks, a total of four patients were discontinued from the 20 mg group and eleven patients from the 40 mg group for reductions in CD4+ cell counts.

A healthy immune response was seen in all study arms in a vaccine challenge sub-study conducted in 84 patients. The vaccines were administrated at either 16 or 20 weeks of treatment, and responses were assessed by measuring changes in antibody titers 4 weeks later. The response rates to tetanus toxoid (50%-100%) and polyvalent pneumococcal vaccine (64%-67%) in patients treated with BCX4208 were similar to placebo-treated patients who received tetanus toxoid (50%) and pneumococcal vaccine (64%). The response rates for placebo-treated patients are consistent with responses in normal individuals reported in literature.

The approximate doubling of sUA response rates with BCX4208 seen at 12 weeks was sustained through 24 weeks of treatment. After 24 weeks of treatment, BCX4208 doses of 5 mg, 10 mg, 20 mg and 40 mg/day showed response rates of 40%, 50%, 46% and 55% respectively, compared to 25% for placebo. These results are consistent with the previously reported positive findings at the 12-week primary efficacy time point.

There was a low incidence of gout flares in this study. Gout flares over 24 weeks occurred in 5% of placebo-treated patients compared to 7-16% of patients treated with BCX4208.

“We are very pleased to confirm the continued favorable safety profile and sustained efficacy for BCX4208 as an add-on therapy for gout. The sustained efficacy, healthy immune responses to vaccines, and clean safety profile from 900 patient-months of drug exposure in this study provides a robust basis for Phase 3 trials,” said Dr. William P. Sheridan, Senior Vice President & Chief Medical Officer of BioCryst Pharmaceuticals. “Based on these results, we have selected the 5, 10 and 20 mg doses of BCX4208 for further evaluation.”

Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,800+ scientific posters on ePosters
  • More than 4,000+ scientific videos on LabTube
  • 35 community eNewsletters

Sign In

Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

BioCryst Provides Second Quarter 2012 Financial Results
For the six months ended June 30, 2012, total revenues increased to $16.4 million from $9.2 million in the first half of 2011.
Friday, August 03, 2012
BioCryst Announces Positive Results from Two Phase 2 Trials
The results confirm the safety profile of ulodesine through 52 weeks in Patients with gout.
Wednesday, August 01, 2012
Nancy Hutson Appointed to BioCryst’s Board of Directors
Dr Hutson brings over 30 years of experience as a seasoned professional and leader within the pharmaceutical industry.
Monday, January 30, 2012
BioCryst Pharmaceuticals Presents New BCX4208 Gout Data
Data was presented at the 2011 American College of Rheumatology and the Association of Rheumatology Health Professionals (ACR/ARHP) Annual Scientific Meeting.
Monday, November 21, 2011
Positive Top-Line Results from BCX4208 Phase 2B Gout Study
BioCryst Pharmaceuticals, Inc. announces positive top-line results from its Phase 2b randomized, double-blind, dose-response study of BCX4208 in gout patients.
Monday, October 10, 2011
Scientific News
A New Way to Look at MOFs
International study challenges prevailing view on how metal organic frameworks store gases.
Major Advance in Crystal Structure Prediction Methods
The Cambridge Crystallographic Data Centre (CCDC) announces that the results of its 6th blind test of crystal structure prediction methods demonstrate significant advancement in in comparison with previous tests.
Protein Structure Discovery Opens Window on Basic Life Process
Biochemists at Oregon State University have made a fundamental discovery about protein structure that sheds new light on how proteins fold, which is one of the most basic processes of life.
Clearest Ever Images of Enzyme that Plays Key Roles in Aging, Cancer
UCLA-led research on telomerase could lead to new strategies for treating disease
New Approach to Treating Heparin-induced Blood Disorder
A potential treatment for a serious clotting condition that can strike patients who receive heparin to treat or prevent blood clots may lie within reach by elucidating the structure of the protein complex at its root.
Escape Prevention
Studying flu virus structure brings us a step closer to a permanent vaccine.
Structure of Protein at Root of Muscular Disease Decoded
Researchers at Rice University and Baylor College of Medicine have unlocked the structural details of a protein seen as key to treating a neuromuscular disease.
A Natural Light Switch
MIT scientists identify and map the protein behind a light-sensing mechanism.
First Complete Structural Study Of A Pegylated Protein
Significant data obtained at NUI Galway reports first crystal structure of a protein modified with a single PEG chain.
Cellular Contamination Pathway for Heavy Elements Identified
Berkeley Lab scientists find that an iron-binding protein can transport actinides into cells.
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,800+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,000+ scientific videos