Transition Says FDA Grants Fast Track Status To ELND005 Development Program

(RTTNews) - Transition Therapeutics Inc. (TTHI, TTH.TO) Wednesday said the US Food and Drug Administration has granted fast track designation to the development program for ELND005, which was submitted for the treatment of Neuropsychiatric Symptoms or NPS in Alzheimer's disease. The company's stock surged over 32 percent in the extended trade.

The FDA concluded that the development program for ELND005 for the treatment of NPS in Alzheimer's disease meets their criteria for fast track designation.

This designation enables more frequent interactions with the FDA during drug development. It also indicates that the New Drug Application or NDA may be considered for priority review.

Additionally, portions of marketing applications for drugs with this designation can be submitted before a complete application is submitted, called rolling review.

In the Phase 2 AD Study (AD201), ELND005 was seen to decrease the emergence and severity of specific NPS. ELND005 also led to a sustained reduction of brain Myo-inositol levels, which are believed to play a role in phospho-inositol signaling pathways and synaptic activity.

The objectives of Study AG201 are to evaluate the efficacy, safety and tolerability of ELND005 over 12 weeks of treatment in patients with moderate to severe Alzheimer's disease, who are experiencing at least moderate levels of agitation/aggression.

The study is expected to enroll 400 patients at multiple sites in the U.S., Canada and other selected regions.

Transition's licensing partner, Elan Corporation, Plc. (ELAN) is responsible for development and commercialization activities and costs of ELND005.

TTHI, which closed down 2.2 percent at $3.01 on Wednesday, surged 32.56 percent in the extended trade and was at $3.99.