RESEARCH TRIANGLE PARK, NC, USA I May 13, 2015 I BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced the initiation of a Phase 1 clinical trial to evaluate the safety, pharmacokinetics and pharmacodynamics of orally-administered BCX7353 in healthy volunteers. Discovered by BioCryst, BCX7353 is a novel, selective inhibitor of plasma kallikrein in development for prevention of attacks in patients with hereditary angioedema (HAE). BioCryst has successfully completed nonclinical safety studies, as well as in vitro studies in which BCX7353 exhibited potent and selective inhibition of plasma kallikrein. The pharmacokinetic profile of BCX7353 in preclinical studies indicates its potential for once daily dosing.
“We are pleased to advance BCX7353 into the clinic and look forward to reporting results from this trial during the third quarter 2015. The successful development of a once daily, orally administered prophylactic drug that is safe and efficacious would be a game changer and a convenient treatment alternative for patients suffering from HAE,” said Jon P. Stonehouse, President & Chief Executive Officer of BioCryst.
The main goals of the Phase 1 clinical trial are to assess safety, characterize plasma drug levels in healthy volunteers, and estimate the extent of kallikrein inhibition achieved after oral dosing of BCX7353.
About Hereditary Angioedema
HAE is a rare, severely debilitating and potentially fatal genetic condition that occurs in approximately 1 in 50,000 people. HAE symptoms include recurrent episodes of edema in various locations, including the hands, feet, face, genitalia and airways. In addition, patients often have bouts of excruciating abdominal pain, nausea and vomiting that are caused by swelling in the intestinal walls. Airway swelling is particularly dangerous and can lead to death by asphyxiation. Further information regarding HAE can be found at www.haea.org.
About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals designs, optimizes and develops novel small molecule drugs that block key enzymes involved in rare diseases. BioCryst currently has several ongoing development programs: oral inhibitors of plasma kallikrein for hereditary angioedema, including BCX4161, BCX7353 and other second generation compounds, and BCX4430, a broad spectrum viral RNA polymerase inhibitor. In December 2014, RAPIVABTM (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, was approved by the FDA and is available to treat flu patients in the U.S. For more information, please visit the Company’s website at www.BioCryst.com.
SOURCE: BioCryst Pharmaceuticals
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RESEARCH TRIANGLE PARK, NC, USA I May 13, 2015 I BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced the initiation of a Phase 1 clinical trial to evaluate the safety, pharmacokinetics and pharmacodynamics of orally-administered BCX7353 in healthy volunteers. Discovered by BioCryst, BCX7353 is a novel, selective inhibitor of plasma kallikrein in development for prevention of attacks in patients with hereditary angioedema (HAE). BioCryst has successfully completed nonclinical safety studies, as well as in vitro studies in which BCX7353 exhibited potent and selective inhibition of plasma kallikrein. The pharmacokinetic profile of BCX7353 in preclinical studies indicates its potential for once daily dosing.
“We are pleased to advance BCX7353 into the clinic and look forward to reporting results from this trial during the third quarter 2015. The successful development of a once daily, orally administered prophylactic drug that is safe and efficacious would be a game changer and a convenient treatment alternative for patients suffering from HAE,” said Jon P. Stonehouse, President & Chief Executive Officer of BioCryst.
The main goals of the Phase 1 clinical trial are to assess safety, characterize plasma drug levels in healthy volunteers, and estimate the extent of kallikrein inhibition achieved after oral dosing of BCX7353.
About Hereditary Angioedema
HAE is a rare, severely debilitating and potentially fatal genetic condition that occurs in approximately 1 in 50,000 people. HAE symptoms include recurrent episodes of edema in various locations, including the hands, feet, face, genitalia and airways. In addition, patients often have bouts of excruciating abdominal pain, nausea and vomiting that are caused by swelling in the intestinal walls. Airway swelling is particularly dangerous and can lead to death by asphyxiation. Further information regarding HAE can be found at www.haea.org.
About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals designs, optimizes and develops novel small molecule drugs that block key enzymes involved in rare diseases. BioCryst currently has several ongoing development programs: oral inhibitors of plasma kallikrein for hereditary angioedema, including BCX4161, BCX7353 and other second generation compounds, and BCX4430, a broad spectrum viral RNA polymerase inhibitor. In December 2014, RAPIVABTM (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, was approved by the FDA and is available to treat flu patients in the U.S. For more information, please visit the Company’s website at www.BioCryst.com.
SOURCE: BioCryst Pharmaceuticals
Post Views: 110
