Elan and Transition Therapeutics have reported fresh trouble with their partnered Alzheimer's drug, noting that it failed to hit its mid-stage primary endpoints. Late last year the deaths of nine patients in the study prompted investigators to drop the highest dose being used in the trial. But the two developers say they're committed to pushing ahead into Phase III, despite a considerable amount of flak coming from analysts following their progress.
Elan reported that the ELND005 study's cognitive and functional co-primary endpoints "did not achieve statistical significance." Data was being held in reserve, though, for a future scientific meeting. "Based on the preponderance of evidence from both biomarker and clinical data, and after extensive discussions with experts in the field, Elan and Transition Therapeutics intend to advance ELND005 into Phase III development."
That strategy didn't win over any skeptical analysts. "Even though this compound was shown to be safe and well tolerated, its efficacy reported for the Phase II study seems to be rather borderline. Hence we remain skeptical whether this agent will show therapeutic benefits in the planned Phase III trials," Helvea equity researcher Olav Zilian noted.
In other news, Elan also announced that poor market conditions persuaded the pharma company to put the sale of its drug delivery unit, Elan Drug Technologies, on hold. Elan first tried to sell EDT two years ago, but was forced to shelve those plans after the market swooned.
- check out the Elan release
- read the Dow Jones report
- and here's more from the Irish Times on EDT