RESEARCH TRIANGLE PARK, NC, USA I March 25, 2013 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 BCX4161 in healthy volunteers. Discovered by BioCryst, BCX4161 is a novel, selective inhibitor of plasma kallikrein in development for prevention of attacks in patients with hereditary angioedema (HAE).
"Daily, oral administration of a safe and efficacious prophylactic drug would revolutionize treatment for patients suffering from this serious condition," said Jon P. Stonehouse, President & Chief Executive Officer of BioCryst. "BCX4161 has the potential to be the first oral treatment developed specifically for the prevention of HAE attacks."
BioCryst has successfully completed nonclinical safety studies, as well as in vitro and in vivo studies in which BCX4161 exhibited potent and selective inhibition of plasma kallikrein and a favorable safety profile. A poster titled "BCX4161, A Small Molecule Orally Bioavailable Plasma Kallikrein Inhibitor, for the Treatment of Hereditary Angioedema" was presented at the 2013 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in February.
The main goals of the Phase 1 clinical trial are to assess safety, characterize plasma drug levels, and estimate the extent of kallikrein inhibition achieved after oral dosing of BCX4161. This clinical trial is being conducted at Quotient Clinical in the United Kingdom utilizing an integrated Translational PharmaceuticsTM platform and the results are expected to be announced in 2013. If the Phase 1 program achieves its goals, BioCryst plans to initiate a Phase 2 program in HAE patients.
About Hereditary Angioedema
HAE is a rare, severely debilitating and potentially fatal genetic condition that occurs in about 1 in 10,000 to 1 in 50,000 people. HAE symptoms include recurrent episodes of edema in various locations, including the hands, feet, face, genitalia and airway. In addition, patients often have bouts of excruciating abdominal pain, nausea and vomiting that are caused by swelling in the intestinal wall. 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 infectious and inflammatory diseases, with the goal of addressing unmet medical needs of patients and physicians. BioCryst currently has two late-stage development programs: peramivir, a viral neuraminidase inhibitor for the treatment of influenza, and ulodesine, a purine nucleoside phosphorylase (PNP) inhibitor for the treatment of gout. In addition, BioCryst has several early-stage programs: BCX4161 and a next generation oral inhibitor of plasma kallikrein for hereditary angioedema and BCX4430, a broad spectrum antiviral for hemorrhagic fevers. 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 March 25, 2013 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 BCX4161 in healthy volunteers. Discovered by BioCryst, BCX4161 is a novel, selective inhibitor of plasma kallikrein in development for prevention of attacks in patients with hereditary angioedema (HAE).
"Daily, oral administration of a safe and efficacious prophylactic drug would revolutionize treatment for patients suffering from this serious condition," said Jon P. Stonehouse, President & Chief Executive Officer of BioCryst. "BCX4161 has the potential to be the first oral treatment developed specifically for the prevention of HAE attacks."
BioCryst has successfully completed nonclinical safety studies, as well as in vitro and in vivo studies in which BCX4161 exhibited potent and selective inhibition of plasma kallikrein and a favorable safety profile. A poster titled "BCX4161, A Small Molecule Orally Bioavailable Plasma Kallikrein Inhibitor, for the Treatment of Hereditary Angioedema" was presented at the 2013 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in February.
The main goals of the Phase 1 clinical trial are to assess safety, characterize plasma drug levels, and estimate the extent of kallikrein inhibition achieved after oral dosing of BCX4161. This clinical trial is being conducted at Quotient Clinical in the United Kingdom utilizing an integrated Translational PharmaceuticsTM platform and the results are expected to be announced in 2013. If the Phase 1 program achieves its goals, BioCryst plans to initiate a Phase 2 program in HAE patients.
About Hereditary Angioedema
HAE is a rare, severely debilitating and potentially fatal genetic condition that occurs in about 1 in 10,000 to 1 in 50,000 people. HAE symptoms include recurrent episodes of edema in various locations, including the hands, feet, face, genitalia and airway. In addition, patients often have bouts of excruciating abdominal pain, nausea and vomiting that are caused by swelling in the intestinal wall. 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 infectious and inflammatory diseases, with the goal of addressing unmet medical needs of patients and physicians. BioCryst currently has two late-stage development programs: peramivir, a viral neuraminidase inhibitor for the treatment of influenza, and ulodesine, a purine nucleoside phosphorylase (PNP) inhibitor for the treatment of gout. In addition, BioCryst has several early-stage programs: BCX4161 and a next generation oral inhibitor of plasma kallikrein for hereditary angioedema and BCX4430, a broad spectrum antiviral for hemorrhagic fevers. For more information, please visit the Company’s website at www.BioCryst.com.
SOURCE: BioCryst Pharmaceuticals
Post Views: 274
