Name | Title | Contact Details |
---|---|---|
Joseph Griffin |
Vice President, Regulatory Affairs and Quality Assurance / Corporate Compliance Officer | Profile |
Biota Pharmaceuticals is focused on the discovery and development of direct-acting antivirals to treat infections that affect a significant number of patients globally. The Company has four product candidates in development that address viral infections that have limited therapeutic options. We are currently enrolling patients for the Phase 2b SPIRITUS trial for vapendavir, a potent, broad spectrum capsid inhibitor of enteroviruses, for the treatment of human rhinovirus (HRV) infected patients with moderate-to-severe asthma. Our second Phase 2 clinical product candidate is BTA074 (AP611074), a novel topical treatment for genital warts caused by HPV types 6 & 11. We also are developing BTA-C585, an oral fusion inhibitor in development for the treatment of respiratory syncytial virus infections. We anticipate beginning a Phase 1 clinical trial with BTA-C585 in Q3 2105. Laninamivir octanoate, a one-time, inhaled neuraminidase for the treatment of influenza A and B infections has completed a global Phase 2 trial.
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BioAgilytix is a leading bioanalytical contract research organization (CRO) that supports the development of novel therapeutic biologics and biosimilars. Located in Research Triangle Park, North Carolina, BioAgilytix specializes in large-molecule bioanalysis providing critical insight into the safety, efficacy, and mechanism of action of drug candidates throughout the clinical trial process. Specifically, BioAgilytix offers assay development, validation, and sample analysis services for immunoassays and cell-based assays under non-GLP, spirit-of-GLP, and GLP, as well as product release testing under GMP. BioAgilytix is an engaged and energetic partner committed to delivering exceptional value and veteran expertise through a collaborative process that consistently results in successful projects.