By Christopher P. Singer
Transition Therapeutics, Inc. announced in an April 3, 2007 press release that its investigational Alzheimer's disease drug, AZD-103/ELND005, developed in collaboration with Elan Corporation, plc has received Fast Track designation from the FDA. The drug is currently undergoing Phase I clinical trials, and is expected to enter Phase II trials near the end of 2007. The Fast Track designation falls under the FDA Modernization Act of 1997, and facilitates the development and review of a candidate chemical or biologic drug if it is planned to be used in the treatment of a serious and/or life-threatening condition, and shows potential to address an unmet need for such condition.
According to Transition's website, AZD-103/ELND005 breaks down fibrils that are involved in the formation of the amyloid plaques associated with Alzheimer's disease. In early animal model studies, AZD-103/ELND005 was able to prevent onset of Alzheimer's, in addition to being able to slow, stop, and reverse disease progression.
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