RESEARCH TRIANGLE PARK, NC, USA I March 1, 2014 I BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) announced the presentation of two scientific posters today at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in San Diego describing phase 1 clinical trial results for BioCryst’s potent and selective oral kallikrein inhibitor, BCX4161, together with details of the Company’s plasma kallikrein inhibition assay. BCX4161 is currently being evaluated in a Phase 2 clinical trial, OPuS-1, as a potential treatment for the prevention of hereditary angioedema (HAE) attacks.
Poster #138 titled, “BCX4161, An Oral Kallikrein Inhibitor: Safety and Pharmacokinetic Results of a Phase 1 Study in Healthy Volunteers” summarizes BCX4161 safety and drug exposure in this first-in-human placebo-controlled clinical trial. Poster #143 titled, “A Simple, Sensitive and Selective Fluorogenic Assay to Monitor Plasma Kallikrein Inhibitory Activity of BCX4161 in Activated Plasma” describes an assay developed by BioCryst to determine the kallikrein inhibitory activity of BCX4161 in activated plasma from normal subjects and HAE patients. This assay is being used by BioCryst as a pharmacodynamic (PD) biomarker of drug effect in BCX4161 clinical trials.
BCX4161 was generally safe and well tolerated in the Phase 1 clinical trial, and there were no serious or dose limiting adverse events reported. Plasma levels of BCX4161 showed dose-related exposure consistent with saturable absorption, and plasma kallikrein inhibition correlated with BCX4161 levels. Plasma concentrations of BCX4161 met or exceeded the target range (25-40 ng/mL) predicted for efficacy in preventing HAE attacks for 80-90 percent of the dosing interval. The safety, pharmacokinetic (PK) and PD results of this phase 1 clinical trial supported the selection of the 400 mg TID regimen being tested in the ongoing OPuS-1 clinical trial.
“The research presented today at AAAAI expands our understanding of kallikrein inhibition and the activity of BCX4161. The PD assay results have provided a solid foundation for testing ‘4161’s treatment effect in HAE patients,” said Dr. William P. Sheridan, Chief Medical Officer at BioCryst. “We look forward to sharing results from OPuS-1 by the end of the second quarter.”
About BCX4161
Discovered by BioCryst, BCX4161 is a novel, potent and selective inhibitor of plasma kallikrein in Phase 2 development for the prevention of attacks in patients with hereditary angioedema. By inhibiting plasma kallikrein, BCX4161 suppresses bradykinin production. Bradykinin is the mediator of acute swelling attacks 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’s core development programs include BCX4161 and two next generation oral inhibitors of plasma kallikrein for hereditary angioedema; peramivir, a viral neuraminidase inhibitor for the treatment of influenza; 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: 161
RESEARCH TRIANGLE PARK, NC, USA I March 1, 2014 I BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) announced the presentation of two scientific posters today at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in San Diego describing phase 1 clinical trial results for BioCryst’s potent and selective oral kallikrein inhibitor, BCX4161, together with details of the Company’s plasma kallikrein inhibition assay. BCX4161 is currently being evaluated in a Phase 2 clinical trial, OPuS-1, as a potential treatment for the prevention of hereditary angioedema (HAE) attacks.
Poster #138 titled, “BCX4161, An Oral Kallikrein Inhibitor: Safety and Pharmacokinetic Results of a Phase 1 Study in Healthy Volunteers” summarizes BCX4161 safety and drug exposure in this first-in-human placebo-controlled clinical trial. Poster #143 titled, “A Simple, Sensitive and Selective Fluorogenic Assay to Monitor Plasma Kallikrein Inhibitory Activity of BCX4161 in Activated Plasma” describes an assay developed by BioCryst to determine the kallikrein inhibitory activity of BCX4161 in activated plasma from normal subjects and HAE patients. This assay is being used by BioCryst as a pharmacodynamic (PD) biomarker of drug effect in BCX4161 clinical trials.
BCX4161 was generally safe and well tolerated in the Phase 1 clinical trial, and there were no serious or dose limiting adverse events reported. Plasma levels of BCX4161 showed dose-related exposure consistent with saturable absorption, and plasma kallikrein inhibition correlated with BCX4161 levels. Plasma concentrations of BCX4161 met or exceeded the target range (25-40 ng/mL) predicted for efficacy in preventing HAE attacks for 80-90 percent of the dosing interval. The safety, pharmacokinetic (PK) and PD results of this phase 1 clinical trial supported the selection of the 400 mg TID regimen being tested in the ongoing OPuS-1 clinical trial.
“The research presented today at AAAAI expands our understanding of kallikrein inhibition and the activity of BCX4161. The PD assay results have provided a solid foundation for testing ‘4161’s treatment effect in HAE patients,” said Dr. William P. Sheridan, Chief Medical Officer at BioCryst. “We look forward to sharing results from OPuS-1 by the end of the second quarter.”
About BCX4161
Discovered by BioCryst, BCX4161 is a novel, potent and selective inhibitor of plasma kallikrein in Phase 2 development for the prevention of attacks in patients with hereditary angioedema. By inhibiting plasma kallikrein, BCX4161 suppresses bradykinin production. Bradykinin is the mediator of acute swelling attacks 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’s core development programs include BCX4161 and two next generation oral inhibitors of plasma kallikrein for hereditary angioedema; peramivir, a viral neuraminidase inhibitor for the treatment of influenza; 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: 161
