GliaCure’s Lead Product, GC021109, Receives FDA Fast Track Designation
GliaCure’s lead product candidate for Alzheimer’s disease, GC021109, has been awarded Fast Track status by the FDA. Biological products are eligible for Fast Track designation if they are intended to treat a serious or life-threatening disease or condition and demonstrate the potential to address unmet medical needs for the disease or condition. The Fast Track designation facilitates more frequent meetings with the FDA to discuss all aspects of development and allows submission of a new drug application on a rolling basis as data become available.
GliaCure board member Joseph Zakrzewski said, “Being awarded Fast Track status for GC021109 is a major achievement for the company. This designation for GC021109 by the FDA is a recognition of the significant unmet medical need for patients with Alzheimer’s disease and the potential our approach offers for these patients.”
As reported previously, a first-in-human Phase 1a study of GC021109 began on September 22, 2014. GliaCure is currently planning its Phase 1b trial, a multiple ascending dose study in mild-to-moderate Alzheimer’s patients.
Press release 20141111 Fast Track