ATLANTA, GA, USA I June 11, 2013 I Biota Pharmaceuticals, Inc. (BOTA) (the “Company”) today announced that it has commenced dosing in a multi-national, randomized, double blind, placebo controlled, parallel arm Phase 2 clinical trial of laninamivir octanoate, a long-acting neuraminidase inhibitor. The trial, referred to as “IGLOO”, will compare the safety and efficacy of 40 mg and 80 mg of laninamivir octanoate with placebo, all delivered by a TwinCaps(R) inhaler in adults with symptomatic influenza A or B infection. The trial is designed to enroll 636 subjects, randomized equally across the three treatment arms, with the primary end point being the time to alleviation of influenza symptoms. Secondary end points include whether the use of laninamivir octanoate reduces the incidence of secondary bacterial infections compared to placebo. The Company‘s goal is to have top-line data from this trial available in mid-2014.
IGLOO is being conducted under the Company’s contract with the U.S. Office of Biomedical Advanced Research and Development Authority (“BARDA“). Further details regarding the design of IGLOO are available at www.clinicaltrials.gov.
“The initiation of this robust, multi-center Phase 2 trial for the treatment of influenza is an important milestone in the clinical development of laninamivir octanoate,” stated Dr. John Lambert, the Company’s Vice President of Product Development. “We believe that the potential for once-only inhaled dosing of laninamivir octanoate could represent a significant advantage over the five-day, twice-daily dosing associated with the currently marketed neuraminidase inhibitors to treat influenza.”
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 in development: laninamivir octanoate, which it is developing under an existing contract with BARDA that is intended to provide up to $231 million in financial support for the Company to complete the clinical development of laninamivir octanoate for the treatment of influenza A and B infections in the U.S.; and vapendavir, a potent, oral broad-spectrum capsid inhibitor of human rhinovirus. In addition to these clinical-stage programs, the Company has preclinical programs focused on developing treatments for respiratory syncytial virus and gram-negative and multi-drug resistant bacterial infections. The Company has a world-wide license from Daiichi Sankyo Company, Ltd to develop and commercialize a number of long-acting neuraminidase inhibitors, including laninamivir octanoate, which is marketed by Daiichi Sankyo in Japan as Inavir(R). The Company receives a royalty on net sales of Inavir(R) in Japan, as well as on global net sales of Relenza(R), a first-generation neuraminidase inhibitor marketed by GlaxoSmithKline. For additional information about the Company, please visit www.biotapharma.com.
SOURCE: Biota
Post Views: 244
ATLANTA, GA, USA I June 11, 2013 I Biota Pharmaceuticals, Inc. (BOTA) (the “Company”) today announced that it has commenced dosing in a multi-national, randomized, double blind, placebo controlled, parallel arm Phase 2 clinical trial of laninamivir octanoate, a long-acting neuraminidase inhibitor. The trial, referred to as “IGLOO”, will compare the safety and efficacy of 40 mg and 80 mg of laninamivir octanoate with placebo, all delivered by a TwinCaps(R) inhaler in adults with symptomatic influenza A or B infection. The trial is designed to enroll 636 subjects, randomized equally across the three treatment arms, with the primary end point being the time to alleviation of influenza symptoms. Secondary end points include whether the use of laninamivir octanoate reduces the incidence of secondary bacterial infections compared to placebo. The Company‘s goal is to have top-line data from this trial available in mid-2014.
IGLOO is being conducted under the Company’s contract with the U.S. Office of Biomedical Advanced Research and Development Authority (“BARDA“). Further details regarding the design of IGLOO are available at www.clinicaltrials.gov.
“The initiation of this robust, multi-center Phase 2 trial for the treatment of influenza is an important milestone in the clinical development of laninamivir octanoate,” stated Dr. John Lambert, the Company’s Vice President of Product Development. “We believe that the potential for once-only inhaled dosing of laninamivir octanoate could represent a significant advantage over the five-day, twice-daily dosing associated with the currently marketed neuraminidase inhibitors to treat influenza.”
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 in development: laninamivir octanoate, which it is developing under an existing contract with BARDA that is intended to provide up to $231 million in financial support for the Company to complete the clinical development of laninamivir octanoate for the treatment of influenza A and B infections in the U.S.; and vapendavir, a potent, oral broad-spectrum capsid inhibitor of human rhinovirus. In addition to these clinical-stage programs, the Company has preclinical programs focused on developing treatments for respiratory syncytial virus and gram-negative and multi-drug resistant bacterial infections. The Company has a world-wide license from Daiichi Sankyo Company, Ltd to develop and commercialize a number of long-acting neuraminidase inhibitors, including laninamivir octanoate, which is marketed by Daiichi Sankyo in Japan as Inavir(R). The Company receives a royalty on net sales of Inavir(R) in Japan, as well as on global net sales of Relenza(R), a first-generation neuraminidase inhibitor marketed by GlaxoSmithKline. For additional information about the Company, please visit www.biotapharma.com.
SOURCE: Biota
Post Views: 244
