Elan drops doses in clinical trial
Pharmaceutical firm Elan announced this morning it has dropped doses in a clinical trial of a new drug it has been testing for Alzheimer's disease.
The decision to modify the Phase II trial dosages comes after the deaths of nine patients who were receving the drug.
Greater rates of serious adverse events, including the deaths, were observed among patients receiving high doses of tthe ELN005 compound. However, Elan stressed a direct relationship between the trial drug and the deaths has not been established.
Elan said that as a precautionary measure which was taken in conjunction with its trial parter Transition Therapeutics and The Independent Safety Monitoring Committee (ISMC), patients will be withdrawn immediately from the study which uses the ELND005 compound in the two higher dose groups (1000mg and 2000mg dosed twice daily).
However, the study will continue unchanged for patients who are assigned to the lower dose (250mg dosed twice daily) and placebo groups.
ELND005 is an orally-administered therapeutic agent that has received designation from the US Food and Drug Administration (FDA) for treatment of mild to moderate Alzheimer's disease.
"Today's decision speaks to our strong commitment to patient safety while allowing for the continued evaluation of ELND005 at the 250mg dose, twice daily," said Menghis Bairu, chief medical officer and head of Global Development at Elan.
"We continue to expect the ongoing study to provide important data to guide the next steps in the development of ELND005 for the potential treatment Alzheimer's disease."
Shares in Elan were trading down 11c to 4.34 on the Dublin market at 2pm this afternoon.