The Phase II clinical trial was designed to test the safety and efficacy of CS-8958 in several hundred adult patients who had confirmed, naturally acquired influenza A or B using fever and symptom resolution endpoints after a single inhaled dose. The study was conducted in accordance with guidance from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). In the double-blinded trial, inhaled CS-8958 administered once only was statistically indistinguishable from 75mg of oseltamivir administered twice daily for 5 consecutive days. In earlier pre-clinical tests, CS-8958 has also shown efficacy against H5N1 avian influenza virus as well as influenza A and B.
Biota and Daiichi-Sankyo are satisfied that the safety, tolerability and efficacy data has fully demonstrated proof of concept for LANI and therefore intend to continue with the product's clinical development. The Phase II results are being used to finalise the design of the pivotal Phase III registration trial due to be conducted in the next northern hemisphere autumn/winter influenza season. It is intended that the Phase III study be pan-Asian and include Japan, Taiwan, Hong Kong and Korea.
A parallel Phase II study, undertaken elsewhere in Asia, has also completed dosing. The results of both trials will be used to support the international regulatory and development program planned for LANI.
Biota CEO, Peter Cook said "This is an important milestone for LANI. We congratulate our partner, Daiichi-Sankyo, for a timely completion of Phase II."
A range of other LANI type compounds are also co-owned by Biota and
Daiichi-Sankyo and are in pre-clinical development under a grant from the US National Institutes of Health.
Daiichi-Sankyo Co. Ltd (TSE:4568) is one of Japan's largest pharmaceutical companies.
Daiichi-Sankyo has a long history of discovering new classes of drugs, including the first-in-class statin drug for treatment of high cholesterol. In 2003, Daiichi-Sankyo and Biota combined their LANI research programs.
About LANIs (Long-Acting Neuraminidase Inhibitors)
Current neuraminidase inhibitors for influenza require daily or more frequent dosing. The ability to dose patients on a weekly, or even less frequent, basis offers numerous benefits. Firstly, any stockpile of weekly-dosing drug will last longer and protect more people, in the case of an influenza pandemic. Additionally, a weekly dose may improve patient compliance over a more frequent regime.
Daiichi-Sankyo Company Limited
Biota Holdings Limited