Cortech's Bradycor Has Effect In Ph II

Cortech, in collaboration with the American Brain Injury Consortium,has revealed that additional data from a Phase II trial of its bradykinin antagonist Bradycor suggest that the drug may improve functional outcome in patients with severe traumatic brain injury.

The US trial involved 133 patients and was conducted by licensee SmithKline Beecham after some delay caused by "anomalous" results from a small pharmacokinetic study in rats in which an unexplained mortality was seen in test animals (Marketletter October 28, 1996). Following the announcement of negative data from the acute phase of the study in March, in which Bradycor was found not to have a significant effect on intracranial pressure, the collaboration was terminated. However, at this time, the analysis of long-term functional outcome was still pending, says the company.

Efficacy In Severe Brain Trauma Anthony Marmarou, technical director of ABIC, presented these latest data last week at the International Neurotrauma meeting in Seoul, South Korea. He commented that in the most severe patients, those with Glasgow Coma Scores of three or four, there was an 18% difference in the percentage of patients with a good or moderate outcome on Bradycor compared to placebo at three months. This was a statistically significant benefit, Dr Marmarou added, and moreover, patients treated with Bradycor had improved recovery at three months as indicated by cognitive function assessments.