The development work will be funded under a $5.6 million grant to Biota from the US National Institutes of Health (NIH).
Under the agreement, Aerogen will undertake development of an aerosol formulation of CS-8958, a long-acting neuraminidase inhibitor (LANI) compound, and supply drug formulation and devices for the clinical studies to be conducted by Biota. The aim will be to develop a formulation of the drug suitable for use with Aerogen’s Aeroneb Go Micropump Nebulizer.
The phase I clinical studies, which will be conducted by Biota, will evaluate the safety and tolerability of an aerosolized formulation of CS-8958 and establish the dosage for subsequent trials.
“The Aeroneb Go Nebulizer is particularly suited for delivery of LANI; it is efficient and easy to use by patients of all ages. We are looking forward to working closely with Biota on this important development activity,” said Dr Jane Shaw, Aerogen’s chairman and CEO.
“Stockpiling of flu antivirals is a critical issue for many governments, especially with the current outbreaks of the highly pathogenic avian influenza in Asia; LANI could become the first line of defense against pandemic influenza,” commented Dr Jane Ryan, director of business development at Biota and principal investigator of the overall program.
LANI are being co-developed by Biota and Sankyo as second generation antivirals for the treatment and prevention of influenza. If successful, the new drugs could have significant advantages over current flu antivirals, including an extended duration of action that could see the drug administered as a single dose for treatment or a weekly dose for prevention.