Admin
1st October 2009, 05:25 AM
Press Release:
BioCryst Announces Initiation of Phase 2 Study of BCX4208 for the Treatment of GoutBioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that it is initiating a Phase 2 study of BCX4208 for the treatment of gout. The primary objective of BioCryst's Phase 2 study is to determine the effect of different doses of orally administered BCX4208 on serum uric acid levels in patients with gout. The gout trial is expected to enroll up to 120 subjects.
"Over the last few decades gout has markedly increased in incidence and prevalence, both in the U.S. and elsewhere. This includes a greater number of difficult cases of chronic or frequently recurrent gout in patients who are intolerant or refractory to the currently approved uric acid lowering drugs," stated Robert Terkeltaub, M.D., VA Rheumatology Section Chief, San Diego Professor of Medicine. "The longstanding unmet need for innovative therapies to reduce hyperuricemia is now being addressed by novel agents, among them BCX4208, that act as novel therapeutics affecting uric acid formation or elimination."
Additionally, Michael A. Becker, M.D., Professor of Medicine Emeritus at The University of Chicago said, "Marked urate lowering effects have been observed in studies in healthy subjects administered BCX4208, achieved by a mechanism unlike that of any currently available gout treatment. This clinical trial of BCX4208 is important for the five million Americans suffering with this disease who need alternatives to current therapies for gout."
The study is a Phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of BCX4208 in subjects with gout. The study's primary endpoint is the change in uric acid in the blood compared to baseline measurement prior to treatment. In a previous study of BCX4208 in patients with psoriasis, patients were administered daily doses up to 120 mg for 6 weeks. Results showed that BCX4208 was safe and well tolerated up to the maximum dose studied, and produced a statistically significant reduction in uric acid concentration in patients.
"BioCryst is pleased to be able to progress the clinical development of BCX4208, a novel and potent PNP inhibitor, with this Phase 2 clinical trial in gout. We expect that the study will define dosing suitable for further development and research in this new indication," said Dr. William P. Sheridan, Chief Medical Officer at BioCryst. "This is an important step in our strategy to broaden the utility of our PNP inhibitors and to deliver a new treatment option to patients with this disease."
BCX4208 is a next generation purine nucleoside phosphorylase (PNP) inhibitor with the potential for once-a day dosing suitable for chronic administration. A recent study has shown that BCX4208 may have utility in diseases dependent on T-cells, B-cells or uric acid. With its novel mechanism of action, BCX4208 has the potential to address unmet medical needs across a broad spectrum of inflammatory diseases.
BioCryst Announces Initiation of Phase 2 Study of BCX4208 for the Treatment of GoutBioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that it is initiating a Phase 2 study of BCX4208 for the treatment of gout. The primary objective of BioCryst's Phase 2 study is to determine the effect of different doses of orally administered BCX4208 on serum uric acid levels in patients with gout. The gout trial is expected to enroll up to 120 subjects.
"Over the last few decades gout has markedly increased in incidence and prevalence, both in the U.S. and elsewhere. This includes a greater number of difficult cases of chronic or frequently recurrent gout in patients who are intolerant or refractory to the currently approved uric acid lowering drugs," stated Robert Terkeltaub, M.D., VA Rheumatology Section Chief, San Diego Professor of Medicine. "The longstanding unmet need for innovative therapies to reduce hyperuricemia is now being addressed by novel agents, among them BCX4208, that act as novel therapeutics affecting uric acid formation or elimination."
Additionally, Michael A. Becker, M.D., Professor of Medicine Emeritus at The University of Chicago said, "Marked urate lowering effects have been observed in studies in healthy subjects administered BCX4208, achieved by a mechanism unlike that of any currently available gout treatment. This clinical trial of BCX4208 is important for the five million Americans suffering with this disease who need alternatives to current therapies for gout."
The study is a Phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of BCX4208 in subjects with gout. The study's primary endpoint is the change in uric acid in the blood compared to baseline measurement prior to treatment. In a previous study of BCX4208 in patients with psoriasis, patients were administered daily doses up to 120 mg for 6 weeks. Results showed that BCX4208 was safe and well tolerated up to the maximum dose studied, and produced a statistically significant reduction in uric acid concentration in patients.
"BioCryst is pleased to be able to progress the clinical development of BCX4208, a novel and potent PNP inhibitor, with this Phase 2 clinical trial in gout. We expect that the study will define dosing suitable for further development and research in this new indication," said Dr. William P. Sheridan, Chief Medical Officer at BioCryst. "This is an important step in our strategy to broaden the utility of our PNP inhibitors and to deliver a new treatment option to patients with this disease."
BCX4208 is a next generation purine nucleoside phosphorylase (PNP) inhibitor with the potential for once-a day dosing suitable for chronic administration. A recent study has shown that BCX4208 may have utility in diseases dependent on T-cells, B-cells or uric acid. With its novel mechanism of action, BCX4208 has the potential to address unmet medical needs across a broad spectrum of inflammatory diseases.