Biota Begins Dosing In Phase 2 IGLOO Trial Of LANI In Northern Hemisphere

(RTTNews) - Biota Pharmaceuticals, Inc. (BOTA), Thursday said it began dosing patients in the Northern Hemisphere portion of its ongoing Phase 2 clinical trial of laninamivir octanoate or LANI. The trial named IGLOO, compares the safety and efficacy of 40 mg and 80 mg of LANI with placebo, all delivered by a TwinCaps inhaler in adults with presumed influenza A or B infection. IGLOO is being conducted in connection with the company's contract with the U.S. Office of Biomedical Advanced Research and Development Authority.

The trial was started in the Southern Hemisphere in June and is now continuing in multiple countries in the Northern Hemisphere. The company intends to finsih enrollment in the IGLOO trial by the end of the influenza season in the Northern Hemisphere and have top-line data available in mid-2014.

The company currently has two Phase 2 clinical-stage product candidates; LANI, a long-acting neuraminidase inhibitor that the company is developing for the treatment of influenza A and B infections under an IND in the U.S. and through a contract with 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.