Biota's flu drug enters Ph II trials

Melbourne, Australia-based Biota Holdings says that its long-acting neuraminidase inhibitor anti-influenza drug, CS8958, has commenced Phase II clinical evaluation and the first patient has started treatment. The study is being carried out by Daiichi-Sankyo in the northern hemisphere influenza season.

As part of the Phase II program, two trials are planned, one in Japan and the other elsewhere in Asia, aiming to test the effectiveness of CS8958 in adult patients who have naturally acquired influenza A or B. Fever resolution after a single inhaled dose of CS8958 will be the primary end point, although flu carries a range of symptoms in addition to fever.

The double-blind trials will examine the safety and efficacy of CS8958 and assist in selecting the best doses for treating flu. However, the duration of the study will depend on the severity of the influenza season and hence the availability of patients for the trial, the firm noted.