Lundbeck has suffered a setback with the news that its acute ischaemic stroke drug desmoteplase has failed in a late-stage study, casting doubt over the whole development programme.
The Danish drugmaker has presented top-line data from the first of two Phase III studies in patients treated in the time-window of three-nine hours after stroke onset. The trial did not meet the primary endpoint, ie the proportion of patients with a favourable outcome of modified Rankin Scale score 0-2 at day 90 was not statistically different between those treated with desmoteplase (51.3%) and placebo (49.8%).
Anders Gersel Pedersen, head of R&D at Lundbeck, said “it is obviously disappointing for us, treating physicians and patients that desmoteplase did not met the primary endpoint in the study”. He added that this was particularly galling, considering that the drug “seems safe and showed an effect in the predefined per protocol population”, noting that “we will now consult with clinical and regulatory experts about the future of the desmoteplase project".
Desmoteplase, a fibrin-dependent plasminogen activator, is a genetically engineered version of a clot-dissolving protein found in the saliva of a vampire bat. The drug, which Lundbeck notes showed an excellent tolerability profile, has fast-track designation from the US Food and Drug Administration.