Forest stroke drug ‘fails to meet study endpoint’

Forest Laboratories and Paion have announced the top-line results of a phase III clinical trial of the compound desmoteplase. The companies revealed that the compound did not meet its primary efficacy endpoint of a difference compared to placebo in a percentage of composite responders.

In the study of acute ischemic stroke patients, individuals were administered with either 90 mcg/kg or 125 mcg/kg of desmoteplase, or a placebo, as an intravenous bolus between three and nine hours following their stroke.

Patients were assessed under three distinct criteria; improvement by eight or more points on the National Institutes of Health Stroke Scale, a score of zero to two on the Modified Rankin Scale and a score of 75-100 on the Barthel Index.

Forest Laboratories reported no significant difference in the composite of these three criteria in the placebo arm and patients treated with desmoteplase.

“These data are surprising and are not consistent with previously observed patterns in the Dias/Dedas trials and larger size, placebo-controlled acute stroke trials,” the company reports.

It adds that this lack of consistency requires a complex explanation, with deep analysis required to furnish the firm with better understanding of the data from the clinical trials.

Desmoteplase is a clot-dissolving protein derived from the saliva of vampire bats.

In August 2006, Lundbeck signed a deal with Paion to fund part of the development costs of the compound.