Lundbeck Presents Updated Phase 3 Results For Stroke Drug Desmoteplase
By C. Rajan, contributing writer
Danish CNS drug maker Lundbeck has presented additional results from its Phase 3 (DIAS-3) study of desmoteplase in patients with acute ischemic stroke, who were treated within 3 to 9 hours after onset of symptoms. These results follow the previous data presented in June 2014, which had indicated that the study did not meet the primary endpoint.
In the updated study results, Lundbeck reports new efficacy and safety data analyses for the stroke drug, which indicate desmoteplase possesses good safety and tolerability profiles. The study was a randomized, double-blind, placebo-controlled study that enrolled 479 patients from Europe and Asia, who were treated with desmoteplase or placebo within 3 to 9 hours after symptoms began to show.
While the new data also does not show any significant difference in the primary endpoint between the drug and placebo, it was found that patients in the per-protocol population treated with desmoteplase showed better functional outcome compared to placebo. This result clinically translates to less disability experienced by patients, even when the treatment is administered as long as nine hours after symptom onset.
The company presented these new findings at the 9th World Stroke Congress in Istanbul, Turkey on October 25, 2014.
Given the mixed results in the DIAS-3 trial, the company plans to meet with regulatory authorities to discuss the next steps with this drug. Based on the data analyses, the company also suggests that magnetic resonance imaging (MRI) would be a better tool than computed tomography (CT) scanning when identifying patients to include in future desmoteplase trials. The results showed that patients identified by MRI and treated with desmoteplase demonstrated better functional outcome than those who were selected for the trial with CT.
Desmoteplase is a genetically engineered version of a clot-dissolving protein found in bat saliva, and works as a fibrin-dependent plasminogen activator. Originally developed by PAION GmbH, desmoteplase has received fast-track designation from the U.S. FDA for the treatment of acute ischemic stroke.
Lundbeck aims to continue development of this drug with advice from clinical and regulatory experts, given the fact that there is no other drug currently available for treatment of stroke during the nine-hour period after symptoms begin to show. Also, the positive results seen in the per-protocol population and the good safety profile of the drug in the clinical trials indicate that desmoteplase has merit in further development.
Stroke is the second largest cause of mortality globally and the third leading cause of disability, according to Lundbeck’s press release. There are approximately 795,000 cases of stroke in the U.S. every year — around 150 to 200 cases per 100,000 people.