Desmoteplase enters clinical phase II in Japan in ischaemic stroke representing Lundbeck's first clinical programme in Japan
H. Lundbeck A/S announced the initiation of the first Japanese clinical phase II trial with desmoteplase (DIAS-J) in the treatment of acute ischaemic stroke. This study is required for the approval of the substance for the Japanese market. In 2009 Lundbeck successfully performed a phase I study in around 30 healthy Japanese volunteers with no safety concern observed.
The primary objective of this randomised, double-blind, placebo-controlled, dose-escalation study is to evaluate the safety and tolerability of desmoteplase in 48 Japanese patients with acute ischaemic stroke. Two doses of desmoteplase (70 and 90 µg/kg) will be tested versus placebo. The efficacy of desmoteplase will be assessed after 90 days. The DIAS-J study is expected to take around 1½ years to conduct and once DIAS-J is completed the subsequent development strategy and the clinical data package necessary for a Japanese NDA will be determined.
"We are very pleased with the progress of this project in order to ensure that also the Japanese stroke patients get access to this innovative medicine and thereby potentially preventing significant disabilities," says Executive Vice President Anders Gersel Pedersen, Head of Drug Development at Lundbeck. "This clinical phase II programme also represents the first Lundbeck-run clinical programme in Japan which represents a major step for Lundbeck".
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