Modifications to Phase II study AD201 and open label extension study AD251 for ELND005 notified

Dec 15 2009

Elan Corporation, plc and Transition Therapeutics, Inc. today notified clinical investigators of modifications to the Phase II study AD201 and open label extension study AD251 for ELND005, a compound being developed for the potential treatment of Alzheimer’s disease. The AD201 study is evaluating three dose levels of ELND005 compared to placebo in 353 patients.

Patients will be withdrawn immediately from the study in the two higher dose groups (1000mg and 2000mg dosed twice daily). The study will continue unchanged for patients who are assigned to the lower dose (250mg dosed twice daily) and placebo groups. The AD251 study will be modified to dose patients only at 250mg twice daily.

The decision by the companies to take these actions was made in concurrence with the Independent Safety Monitoring Committee (ISMC) following a review of the ongoing ELND005-AD201 study. Greater rates of serious adverse events, including nine deaths, were observed among patients receiving the two highest doses. A direct relationship between ELND005 and these deaths has not been established.

The ISMC and both companies concur that the tolerability and safety data are acceptable among patients receiving the 250mg dose and that the blinded study should continue for this dose and the placebo group.

“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, M.D., EVP, 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.”