BioCentury
ARTICLE | Clinical News

Biota's laninamivir octanoate misses in Phase II influenza

August 2, 2014 1:12 AM UTC

Biota Pharmaceuticals Inc. (NASDAQ:BOTA) said laninamivir octanoate delivered via TwinCaps dry-powder inhaler missed the primary endpoint of improving median time to alleviation of influenza symptoms vs. placebo in the intent-to-treat (ITT) population of the Phase II IGLOO trial to treat influenza infection. The double-blind trial enrolled 248 patients with PCR-confirmed influenza A or B infection. Median time to alleviation of influenza symptoms was 102.3 hours for the 40 mg laninamivir octanoate cohort (p=0.248) and 103.2 hours in the 80 mg cohort (p=0.776) vs. 104.1 hours for placebo.

Biota will report full data from IGLOO in September. The company said it does not plan to independently advance the development of laninamivir octanoate to treat influenza infection and will evaluate next steps for the program outside of Japan with partner Daiichi Sankyo Co. Ltd. (Tokyo:4568). Daiichi markets the second-generation long-acting neuraminidase inhibitor (LANI) in Japan as Inavir to prevent influenza A and B infections. ...