Biota Reports Positive Results From HRV Drug Safety Trial

Biota recently announced the successful completion of the second stage of its Phase I safety and tolerability study of BTA798, a potent inhibitor of human rhinovirus (HRV), the major cause of the common cold. The drug has been shown to be safe and well tolerated at all doses. Biota intends to advance the development of the drug to Phase II trials to test the efficacy of the drug.

A safe and effective treatment for HRV would be a major breakthrough for high-risk sufferers of asthma, chronic obstructive pulmonary disease and cystic fibrosis, and in patients with compromised immune systems, according to the company.

The trial involved a total of 32 healthy volunteers and studied the effects of two dose levels, once or twice daily. The study was double-blind and used placebo controls.

Results of the first stage of the study, Phase Ia, were reported in August 2006. The Phase I trial has established BTA798 to be safe and well tolerated in healthy volunteers at all single and multiple doses.

The clinical trial design and the product's data package were approved by an independent ethics committee and the UK's Medical and Healthcare products Regulatory Agency. The trial was conducted in the UK.

BTA798 is an orally available, small-molecule drug that targets the capsid protein on the surface of the human rhinovirus to stop the spread of the virus infection. While HRV is the principal cause of the common cold, Biota intends to develop BTA798 initially for treatment and prevention of HRV infection in those patients considered to be at greatest risk of serious complications if they contract HRV.