GliaCure's Lead Product, GC021109, Receives FDA Fast Track Designation
BOSTON, Nov. 11, 2014 /PRNewswire-USNewswire/ -- GliaCure, a privately-held biotechnology company focused on the development of novel therapies for neurological and neuropsychiatric disorders based on glial targets, announced today that its 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.
About GliaCure, Inc.
GliaCure is a privately held company that is pioneering the development of novel therapeutics aimed at treating neurological and neuropsychiatric disorders of the brain. The company's approaches are based on glial targets, a cell type in the brain that has previously been largely overlooked in drug discovery. GliaCure's lead product candidate, GC021109, is a small molecule that in preclinical studies has demonstrated two primary actions downstream of target engagement: the stimulation of phagocytosis and anti-inflammatory actions in which levels of pro-inflammatory cytokines are reduced. GC021109 is currently being developed primarily as a disease modifying treatment for Alzheimer's disease and commenced a Phase 1a clinical trial for the disorder in Q3 2014. The dual phagocytic and anti-inflammatory actions of GC021109 have the potential to affect other disorders, including psoriasis, Parkinson's disease, and multiple sclerosis. GliaCure has an exclusive license to the GC021109 compound and related technology from Tufts University. GliaCure also has a pipeline program for the development of therapeutics for astrocytic targets related to sleep disorders and depression. The company is based in Boston and is led by Professor Philip G. Haydon, who also holds the position of Chair of Neuroscience at Tufts University.
Contact: Yolande Haydon, 610-246-6012, yolande.haydon@gliacure.com
SOURCE GliaCure, Inc.