Lundbeck's stroke drug fails in advanced clinical trials
- Desmoteplase, which Lundbeck has been developing for the treatment of acute ischemic stroke, failed in phase III clinical trials.
- There was no significant difference in outcomes on the modified Ranklin Scale (mRS) score. The target score was 0-2, suggesting minimal disability, at day 90.
- This failure was a surprise for investigators and is considered a true disappointment, because the drug had demonstrated a strong safety and tolerability profile.
Investigators were hoping for positive outcomes for desmoteplase, a fibrin-dependent plasminogen activator that is a genetically engineered versoin of a clot-dissolving protein found in vampire-bat saliva. Part of their optimism was based on good safety data and the fact that the drug had been fast-tracked by FDA. The mRS measures disability in patients who have had a stroke. Scores range from 0 to 6, with “0” being ‘no symptoms’ and “6” being ‘dead.’
In the study, 51.3% of desmoteplase-treated patients achieved a score between 0 and 2, compared with 49.8% of placebo-treated patients.