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.
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 a Phase-3-ready asset in 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 patients in clinical trials.
Gout is a chronic inflammatory arthritis caused by monosodium urate crystal deposits in joints and the kidneys resulting from elevated 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.
About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals designs, optimizes and develops novel small molecule drugs that block key enzymes involved in infectious and inflammatory diseases. BioCryst currently has two late-stage development programs: peramivir, a viral neuraminidase inhibitor for the treatment of influenza, and BCX4208, a purine nucleoside phosphorylase (PNP) inhibitor for the treatment of gout. In addition, BioCryst is advancing two preclinical programs towards IND filings: BCX5191, a nucleoside analog inhibitor of HCV RNA polymerase (NS5B) for hepatitis C, and BCX4161, an oral inhibitor of plasma kallikrein for hereditary angioedema. Utilizing state-of-the-art structure-guided drug design and crystallography, BioCryst continues to discover innovative compounds with the goal of addressing unmet medical needs of patients and physicians. For more information, please visit the Company's website at www.BioCryst.com.
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 our compounds will prove effective in clinical trials; that development and commercialization of our 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 of our product candidates 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 our product candidates; that our product candidates may not receive required regulatory clearances from the FDA; that ongoing and future preclinical and clinical development may not have positive results; that we or our licensees may not be able to continue future development of our current and future development programs; that our development programs may never result in future product, license or royalty payments being received by BioCryst; that BioCryst may not be able to retain its current pharmaceutical and biotechnology partners for further development of its product candidates or it may not reach favorable agreements with potential pharmaceutical and biotechnology partners for further development of its product candidates; that our actual cash burn rate may not be consistent with our expectations; that BioCryst may not have sufficient cash to continue funding the development, manufacturing, marketing or distribution of its products and that additional funding, if necessary, may not be available at all or on terms acceptable to BioCryst. Please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst's most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and current reports on Form 8-K, all of which identify important factors that could cause the actual results to differ materially from those contained in our projections and forward-looking statements.