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LANI Phase III clinical trials in Asia prove successful against influenza

Biota Holdings Limited has announced successful results from the Asian Phase III clinical trials of CS-8958, its second-generation influenza treatment. CS-8958 has now been assigned the new name of ‘laninamivir’ by the World Health Organization under its International Non-proprietary Names drug identification system.

Laninamivir is a long-acting neuraminidase inhibitor, or LANI, and is co-owned with Daiichi Sankyo. In the Phase III trial in adults, a single inhaled dose of laninamivir was shown to be as effective as oseltamivir (Tamiflu) administered orally twice daily for five days (total of ten doses). A parallel Phase II/III trial of CS-8958 in paediatric patients also met the primary and secondary end points compared to oseltamivir.

‘The success of the multifaceted Phase III trials in Asia is significant. Laninamivir offers a new therapeutic agent in the treatment of influenza with particular advantages for stockpiling applications‘, said Peter Cook, Biota's Managing Director.

The Phase III study was conducted by Daiichi Sankyo in Japan, Taiwan, Hong Kong and Korea and enrolled approximately 1000 adult patients who had confirmed, naturally acquired influenza A or B. Patients in the trial received either 20mg or 40mg of laninamivir as a single inhaled dose or 75mg of oseltamivir twice daily for five days. Participants in the trial were distributed equally across three treatment groups. The primary end point of the trial was time to symptom resolution, and the secondary end point was time for body temperature to return to normal. Both doses of laninamivir were as effective as oseltamivir and were well tolerated.

The parallel Phase II/III double-blind paediatric study of laninamivir was conducted in Japan in approximately 180 children aged nine years or younger. This study also compared the safety and efficacy of 20mg or 40mg of laninamivir as a single inhaled dose with oseltamivir administered at a dose of 2mg/kg twice daily for five days. Approximately 60 children were enrolled in each treatment arm of the study. The primary and secondary end points used in this trial were the same as those used in the adult study. Both doses of laninamivir were equivalent to oseltamivir and were well tolerated by paediatric patients. There was also a trend towards the single inhaled doses of 20mg or 40mg of laninamivir showing a faster time to the alleviation of influenza illness than oseltamivir dosed at 2mg/kg twice daily for five days.

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