ATLANTA, GA, USA I November 19, 2013 I Biota Pharmaceuticals Inc. (“Biota”) (BOTA) announced today that it has commenced dosing in two Phase 1 clinical trials of laninamivir octanoate (“LANI”), its long-acting neuraminidase inhibitor being developed for the treatment of influenza.
One of the Phase 1 clinical trials is a single center, randomized, double-blind, placebo-controlled, single ascending dose study in which the safety and pharmacokinetics of LANI, administered by inhalation via the TwinCaps(R) dry powder inhaler (DPI), will be assessed in adults with mild to moderate chronic asthma. The study is designed to enroll up to 32 subjects. The second Phase 1 clinical trial is a thorough QT/QTc (TQT) study designed to evaluate the effect of therapeutic and supra-therapeutic doses of LANI on cardiac ventricular repolarization, specifically the QT-interval, in healthy volunteers. The study is a single center, parallel design, placebo- and positive-controlled, double-blind, randomized trial. This trial is designed to enroll 168 subjects. Both studies are being conducted to support the requirements of a New Drug Application for LANI. The Company expects top-line results from both of these clinical studies in the first half of 2014.
“We are pleased to augment our ongoing Phase 2 IGLOO clinical trial of LANI with these important studies and anticipate initiating another Phase 1/2 clinical study next month in children aged 5-17 infected with influenza,” stated Russell Plumb, President and Chief Executive Officer of Biota.
About Biota
Biota Pharmaceuticals, Inc. is a biopharmaceutical company focused on the discovery and development of products to prevent and treat serious and potentially life-threatening infectious diseases. The Company currently has two Phase 2 clinical-stage product candidates: LANI, which the Company is developing for the treatment of influenza A and B infections under an IND in the U.S. through a contract with the U.S. Office of Biomedical Advanced Research and Development Authority (BARDA) that is designed to provide up to $231 million in financial support to complete its clinical development; and vapendavir, a potent, oral broad spectrum capsid inhibitor of enteroviruses, including human rhinovirus (HRV). In addition to these clinical-stage programs, the Company has preclinical programs focused on developing treatments for respiratory syncytial virus (RSV) and gram-negative, multi-drug resistant bacterial infections. For additional information about the Company, please visit www.biotapharma.com.
SOURCE: Biota
Post Views: 42
ATLANTA, GA, USA I November 19, 2013 I Biota Pharmaceuticals Inc. (“Biota”) (BOTA) announced today that it has commenced dosing in two Phase 1 clinical trials of laninamivir octanoate (“LANI”), its long-acting neuraminidase inhibitor being developed for the treatment of influenza.
One of the Phase 1 clinical trials is a single center, randomized, double-blind, placebo-controlled, single ascending dose study in which the safety and pharmacokinetics of LANI, administered by inhalation via the TwinCaps(R) dry powder inhaler (DPI), will be assessed in adults with mild to moderate chronic asthma. The study is designed to enroll up to 32 subjects. The second Phase 1 clinical trial is a thorough QT/QTc (TQT) study designed to evaluate the effect of therapeutic and supra-therapeutic doses of LANI on cardiac ventricular repolarization, specifically the QT-interval, in healthy volunteers. The study is a single center, parallel design, placebo- and positive-controlled, double-blind, randomized trial. This trial is designed to enroll 168 subjects. Both studies are being conducted to support the requirements of a New Drug Application for LANI. The Company expects top-line results from both of these clinical studies in the first half of 2014.
“We are pleased to augment our ongoing Phase 2 IGLOO clinical trial of LANI with these important studies and anticipate initiating another Phase 1/2 clinical study next month in children aged 5-17 infected with influenza,” stated Russell Plumb, President and Chief Executive Officer of Biota.
About Biota
Biota Pharmaceuticals, Inc. is a biopharmaceutical company focused on the discovery and development of products to prevent and treat serious and potentially life-threatening infectious diseases. The Company currently has two Phase 2 clinical-stage product candidates: LANI, which the Company is developing for the treatment of influenza A and B infections under an IND in the U.S. through a contract with the U.S. Office of Biomedical Advanced Research and Development Authority (BARDA) that is designed to provide up to $231 million in financial support to complete its clinical development; and vapendavir, a potent, oral broad spectrum capsid inhibitor of enteroviruses, including human rhinovirus (HRV). In addition to these clinical-stage programs, the Company has preclinical programs focused on developing treatments for respiratory syncytial virus (RSV) and gram-negative, multi-drug resistant bacterial infections. For additional information about the Company, please visit www.biotapharma.com.
SOURCE: Biota
Post Views: 42
