Gout, a common form of inflammatory arthritis resulting from high levels of uric acid in the blood , is more common among men and senior citizens. In recent years, the prevalence of gout has significantly increased and an estimated 8.3 million individuals in the U.S. suffer from this painful disease.
The conventional mode of treating gout is by lowering the amount of uric acid in the blood by FDA-approved drugs like Zyloprim (Allopurinol), which has been marketed in the United States since 1966, and Uloric, approved in 2009, both of which are xanthine oxidase inhibitors. Last September, the FDA approved Savient Pharmaceuticals' (SVNT) Krystexxa for gout in adults who do not respond to or who cannot tolerate conventional therapy. Krystexxa is the second new drug approved for gout in more than 40 years, and the first being Takeda Pharmaceuticals' Uloric.
Working on the development of an add-on therapy to other urate-lowering treatments is BioCryst Pharmaceuticals Inc. (BCRX: Quote), a biotechnology company that is also focused on drugs for cancer and influenza.
For readers who are new to BioCryst, here's a brief overview of the company and its upcoming catalysts...
A phase 2b study of BCX4208 as add-on therapy in gout patients who have not responded to the widely-prescribed allopurinol therapy alone was initiated late last year. The 250-patient phase 2b study is designed to evaluate the safety and efficacy of BCX4208 in combination with allopurinol in gout patients who have failed to reach the serum uric acid objective of less than 6 mg/dL following treatment with allopurinol 300 mg alone. In order to reduce future gout attacks, it is important to lower the serum uric acid to a healthy level of less than 6 mg/dL.
The company has already exceeded target enrollment in the ongoing phase 2b study and will report primary efficacy and safety results from the first 12 weeks of treatment early in the fourth quarter (early 4Q). The preliminary 6-month data of the phase 2b study is scheduled for early 2012.
BCX4208 is a next generation purine nucleoside phosphorylase inhibitor with the potential for once-daily dosing for chronic administration. Last year, BioCryst reported positive results from two phase 2 studies of BCX4208 in different doses pitted against placebo in patients with gout.
A 12-week phase 2 study evaluating BCX4208 in about 40 patients with gout and moderately impaired renal function and a phase 1 study evaluating the metabolic profile of BCX4208 are ongoing. Both the studies are expected to conclude by early 2012.
BioCryst's drug pipeline also includes Peramivir, a neuraminidase inhibitor for the treatment of influenza, and Forodesine, an orally-available purine nucleoside phosphorylase inhibitor for hematological malignancies.
Peramivir, an intravenously administered investigational anti-viral agent acts against influenza A and B viruses, including strains of influenza viruses that may be resistant to available neuraminidase inhibitors. The drug is approved in Japan and Korea. In the U.S., Peramivir is being developed under a $234.8 million contract from the Biomedical Advanced Research and Development Authority.
A phase 3 study to evaluate the efficacy and safety of Peramivir administered intravenously in addition to the standard of care Tamiflu compared to standard of care alone in adults and adolescents who are hospitalized due to serious influenza was initiated in November 2009. The study is currently recruiting participants and is expected to be completed by May 2013.
In the U.S., BioCryst has a collaborative agreement with the U.S. Department of HHS (Health and Human Services) for Peramivir, in Japan, with Shionogi & Co. Ltd. and in Korea, with Green Cross Corp.
Forodesine is an orally-available transition-state analog inhibitor of purine nucleoside phosphorylase that has been granted Orphan Drug status by the FDA for three indications: T-cell non-Hodgkin's lymphoma, chronic lymphocytic leukemia and related leukemias and for B-acute lymphoblastic leukemia. Forodesine is under phase III testing for cutaneous T cell lymphoma, phase II development for chronic lymphocytic leukemia and under phase I testing for acute lymphoblastic leukemia.
BioCryst is in dispute with its partner for Forodesine development - Mundipharma International Holdings Ltd., and other potential partnerships for the future development of the drug candidate in the U.S. are being explored. No additional studies will be conducted with Forodesine, sans a partner.
The company also has two preclinical compounds, namely BCX4161 for hereditary angioedema and BCX5191 for treatment of hepatitis C. The IND filings for the two compounds are expected to be made during the second half of 2012.
Founded in 1986, BioCryst went public in March 1994 offering its shares at a price of $6.50 each. In the second quarter ended June 30, 2011, the company incurred a net loss of $16.27 million or $0.36 per share wider than the year-ago quarterly loss of $10.19 million or $0.23 per share. Total revenue in the second quarter of 2011 declined to $3.7 million from $7.6 million in the year-ago comparable quarter due to less revenue recognized under the contract with HHS for the continued development of intravenous Peramivir.
Given the fact that BioCryst has a number of events lined up in the coming quarters, its stock is worth watching.
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by RTT Staff Writer
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