FDA Grants Fast-Track Designation to Transition's Alzheimer's Drug

Transition Therapeutics announced that the FDA has granted fast-track designation to the company's investigational drug candidate AZD-103/ELND005, which is being developed in collaboration with Elan for the treatment of Alzheimer's disease.

AZD-103/ELND005 is currently being evaluated in multiple Phase I clinical studies, and the companies anticipate starting Phase II clinical studies around the end of the year.

Fast-track designation is intended to facilitate the development and expedite the review of a drug or biologic if it will be used for the treatment of a serious or life-threatening condition, and if it demonstrates the potential to address unmet medical needs, according to Transition.

The drug is part of an emerging class that has the potential to both reduce disease progression and improve symptoms such as cognitive function. The drug reduces accumulation of amyloid beta plaque in the brain, as well as reduces or eliminates learning deficits in a leading transgenic mouse model of Alzheimer's disease.