Completion of Phase I Trial on the Anti-influenza Drug CS-8958
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- Published on Thursday, 19 April 2007 04:00
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TOKYO, Japan | Apr 18, 2007 | Daiichi Sankyo Company, Limited announced today that it has completed a Phase I clinical trial in Japan on the Daiichi Sankyo-originated anti-influenza drug CS-8958 and expects to start Phase II trials this fall.
CS-8958 is a long-acting neuraminidase inhibitor that is expected to be used as single administration for treatment and once a week for prophylaxis. The compound is under development as an inhalant that will act directly on the pulmonary and tracheal sites of infection. Non-clinical studies have confirmed its effectiveness against the H5N1 avian influenza virus in addition to its effectiveness against both A and B type seasonal influenza viruses.
CS-8958 was designated as a priority consultation product by the Pharmaceuticals and Medical Devices Agency (PMDA) in August 2006, which will give it priority for consultations on clinical trial planning and other issues. DAIICHI SANKYO aims to file an NDA at the end of 2009 and is pursuing development in full consultation with the regulatory authorities and specialists. As measures to deal with new strains of influenza virus are enhanced, CS-8958 may make an important contribution by increasing the range of options available for treating and preventing flu infections. In Europe and the US, Australia-based Biota Holdings Ltd., a joint development company, is conducting Phase I trials for CS-8958.
SOURCE: Daiichi Sankyo Company, Limited