12:00 AM
Jan 05, 2009
 |  BioCentury  |  Product Development

The clot is the thing

Pharma companies generally don't hesitate to ditch compounds that fail Phase III trials, especially in a difficult area like stroke. But H. Lundbeck A/S did just the opposite last year. The company expanded its license to Paion AG's desmoteplase based on the belief that it has figured out how to enroll the right patients in a new set of Phase III studies that began late last month. The big question is whether clinicians will give the clot buster the benefit of the doubt, or instead treat patients with conventional catheter-based approaches.

In 2007, desmoteplase failed to show clinical benefit in the Phase III DIAS-2 trial to treat acute ischemic stroke. Forest Laboratories Inc., which had held North American rights, returned those to Paion. Lundbeck, which had global rights excluding North America, added the latter territory last January (see BioCentury, June 4, 2007, & Jan. 7, 2008).

Based on a subgroup analysis of DIAS-2 that showed a treatment effect in patients with a detectable clot, Lundbeck designed the new DIAS-3 and DIAS-4 trials to include only patients with detectable blood clots in the main cerebral arteries at the start of treatment. By doing so, Lundbeck hopes to avoid the high placebo response it believes contributed to the previous failure.

Lundbeck is developing the recombinant salivary plasminogen activator to treat acute ischemic stroke three to nine hours from onset. The sole marketed clot buster, Activase alteplase, a recombinant form of human tissue plasminogen activator (tPA) from Genentech Inc., is approved for use only within three hours of stroke.

In its window, desmoteplase potentially could treat the roughly 80% of patients who fall outside...

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