FDAnews
www.fdanews.com/articles/97932-transition-therapeutics-elan-report-data-from-elnd-005-azd-103-studies

Transition Therapeutics, Elan Report Data From ELND-005/AZD-103 Studies

August 31, 2007

Transition Therapeutics and Elan have completed of Phase I clinical studies with Alzheimer’s disease drug candidate ELND-005/AZD-103.

Transition and Elan said they have performed multiple Phase I studies evaluating the safety, tolerability and pharmacokinetic profile of ELND-005/AZD-103 in healthy volunteers.

Approximately 110 subjects have received ELND-005/AZD-103 in multiple Phase I studies. ELND-005/AZD-103 was safe and well-tolerated at all doses and dosing regimens examined, with no severe or serious adverse events observed, according to the companies.

The next steps in the development of ELND-005/AZD-103 will be submission of data supporting Phase II studies to the FDA. The companies said they anticipate starting Phase II trials by the end of the year or in early 2008.