Transition Therapeutics Announces Completion of Phase I Clinical Studies with Alzheimer's Disease Drug Candidate

31-Aug-2007

Transition Therapeutics Inc. announced the completion of Phase I clinical studies with Alzheimer's disease drug candidate ELND-005/AZD-103. Transition and its development partner Elan Corporation, plc. have performed multiple phase I studies evaluating the safety, tolerability and pharmacokinetic profile of ELND-005/AZD-103 in healthy volunteers. Orally administered ELND-005/AZD-103 may act through the unique mechanism of preventing and reversing the fibrilization of beta-amyloid in preclinical studies, presumed to be the toxic peptide in the brain of Alzheimer's patients. According to the company, ELND-005/AZD-103 is well positioned as a potential Alzheimer's therapy as it is a small molecule that crosses the blood brain barrier and has exhibited a favourable safety profile.

Approximately 110 subjects have been exposed to ELND-005/AZD-103 in multiple Phase I studies, including single and multiple ascending dosing; pharmacokinetic evaluation of levels in the brain; and CSF and plasma studies. ELND-005/AZD-103 was safe and well-tolerated at all doses and dosing regimens examined. There were no severe or serious adverse events observed.

ELND-005/AZD-103 was also shown to be orally bioavailable, cross the blood-brain barrier and achieve levels in the human brain and CSF that were shown to be effective in animal models for Alzheimer's disease. The pharmacokinetic data and safety data obtained in the Phase I studies will be used to select the appropriate doses for the Phase II studies.

The next steps in the development of ELND-005/AZD-103 will be submission of data supporting Phase II studies to the FDA. Transition and Elan anticipate starting Phase II by the end of 2007 or early 2008.

https://www.bionity.com/en/news/68532/transition-therapeutics-announces-completion-of-phase-i-clinical-studies-with-alzheimer-s-disease-drug-candidate.html