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news.Transition Therapeutics has reported that Phase I studies with its Alzheimer's disease drug candidate have demonstrated the compound to be safe and well-tolerated.
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Transition and its development partner Elan 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.
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 favorable safety profile, biopharmaceutical company Transition said.
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.