Biota (ASX:BTA) today announced the commencement of a Phase II clinical trial of the antiviral drug BTA798 in patients with chronic asthma. BTA798 is orally administered and active against human rhinovirus, a virus often associated with the common cold. The US Food and Drug Administration (FDA) recently provided regulatory clearance for Biota to conduct the study in the US. BTA798 has previously been shown to reduce the incidence of HRV infection in healthy volunteers in a Phase IIa viral challenge study completed in June 2009.

The trial announced today is designed to investigate the impact of BTA798 on cold and asthma symptoms when given shortly after the onset of an infection. Asthmatics often
suffer a worsening of their asthma when they develop a cold, so are an important group of patients in whom BTA798 may offer considerable benefit.The study is a randomised, placebo-controlled, double-blind trial that will involve approximately 60 sites across the United States and may enrol up to 400 patients. It has been timed to coincide with the peak of the northern hemisphere human rhinovirus cold season, which typically commences in late August. With favourable recruitment conditions, the results of the study may be available as early as mid-2011.

Data will be collected on both the efficacy and safety of BTA798. The primary efficacy endpoint is an assessment of the severity and duration of cold symptoms and their impact on patient functioning. Secondary endpoints include incidence and severity of asthma symptoms, changes in lung function, and duration and intensity of viral shedding from the upper respiratory tract. The trial has been budgeted to cost up to $25 million over two years. A number of major pharmaceutical companies have contributed to the study design. Potential partnering discussions have confirmed the need for a product with the profile of BTA798 in asthmatics. Biota’s investment in the current study, with a successful outcome, should significantly enhance the value of any future licence.