Northern, WI 6/6/12 (StreetBeat) -- BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced that additional safety and efficacy results from its BCX4208 gout program will be presented at the Annual European Congress of Rheumatology hosted by the European League Against Rheumatism (EULAR) in Berlin, Germany on June 7 & 8, 2012.
Three posters summarize pharmacokinetic (PK), safety and efficacy results from BioCryst’s Phase 2b trial of BCX4208 added to allopurinol in patients with gout who had failed to reach the serum uric acid (sUA) therapeutic goal of <6.0 mg/dL on allopurinol alone. Positive 24-week results were reported from this trial earlier this year.
• “BCX4208, A Novel Enzyme Inhibitor for Chronic Management of Gout Shows a Low Risk of Potential Drug-Drug Interactions” concludes that BCX4208 undergoes renal elimination, is not metabolized by liver cells and does not induce, or inhibit, CYP isoforms or common drug transporters. Therefore, BCX4208 should have a low risk of drug-drug interactions with medications commonly prescribed to patients with gout. (Poster FRI0401)
• “Long-term Safety of BCX4208 Added to Allopurinol in the Chronic Management of Gout: Results of a Phase 2 24-week Blinded Safety Extension and Vaccine Challenge Study” concludes that BCX4208 was safe and generally well-tolerated when added to allopurinol. Patients showed no signal for infections and generated a healthy immune response to vaccination. No differences were seen in the rate or severity of adverse events or infections across all treatment groups. (Poster FRI0380)
• “BCX4208 Added to Allopurinol Increases Response Rates in Patients with Gout who Fail to Reach Goal Range Serum Uric Acid on Allopurinol Alone: A Randomized, Double-Blind, Placebo-Controlled Trial” concludes that BCX4208 plus allopurinol doubled the proportion of patients achieving goal of sUA <6 mg/dL compared to allopurinol alone. In a patient subgroup whose baseline sUA was >6.5 mg/dL, a more than 4-fold increase in response was observed when BCX4208 was added to allopurinol compared to allopurinol alone. (Poster FRI0367)
In addition, the abstract “Effect of BCX4208 Add-On Therapy to Allopurinol 300 mg on Plasma Hypoxanthine and Xanthine Concentrations in Gout Patients” was accepted as an oral presentation and concludes that BCX4208 in combination with allopurinol resulted in dose-dependent mean reductions in plasma xanthine and hypoxanthine concentrations in gout patients. These results confirm the mechanism of action of BCX4208. (Abstract OP0106)
“The conclusions from these trials further validate BCX4208’s potential to be a preferred treatment option for physicians and a large portion of their gout patients. We believe BCX4208 offers important differentiating characteristics in comparison to other treatment options,” said Dr. William Sheridan, Senior Vice President & Chief Medical Officer of BioCryst. “BioCryst has successfully completed a high quality Phase 2 proof-of-concept program and an informative end of Phase 2 meeting with the FDA, and we are continuing discussion with potential partners who are evaluating licensing BCX4208 for Phase 3 development and commercialization.”
Copies of all abstracts are available online through the EULAR website at www.eular.org. The poster and oral presentations will be made available on BioCryst’s BCX4208 publications page once they have been presented on June 8, 2012.
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