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LANI completes Phase I in Japan and to commence Phase I in UK

27 Apr 2007 - Biota Holdings Limited announced that its long acting neuraminidase inhibitor (LANI), CS8958, an anti-influenza treatment, has demonstrated effectiveness against the avian flu virus H5N1, completed Phase I studies in Japan and received ethics approval to commence comparable studies in the UK.
 
Biota's partner for LANI, Daiichi-Sankyo, announced that laboratory studies had confirmed CS8958's effectiveness against the avian flu virus H5N1 in addition to its effectiveness against influenza A and B type non-avian viruses. Daiichi-Sankyo also announced that it has completed a Phase I clinical trial in Japan on CS8958 and expects to start Phase II studies in October.
 
The UK studies shall extend the safety and pharmacokinetics studies of CS8958 in man. The double-blinded study will involve up to 40 healthy volunteers using a single dose, and will trial up to four separate, single dose levels. The study is being funded as part of a US$5.6 million grant provided by the US National Institutes of Health. The studies will utilise a newly licensed inhaler designed by Hovione and complement the studies completed by Daiichi-Sankyo in Japan. The UK studies will generate data in western subjects and lay the basis for further clinical development outside Japan.
 
CS8958 is a long acting neuraminidase inhibitor and offers higher potency, lower dose and the potential for once only treatment and once weekly prophylactic protection from influenza. These properties are known consumer advantages over existing inhaled and oral therapies. CS8958 and a range of other LANI type compounds are co-owned by Biota and Daiichi-Sankyo.