25
Sep

2014

GliaCure Enters First-in-Human Clinical Trial in Alzheimer’s Disease

GliaCure today distributed the following press release:

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 has initiated dosing of healthy volunteers in a first-in-human Phase 1a clinical trial of its lead product candidate, GC021109, a novel compound developed as a disease-modifying treatment for Alzheimer’s disease. In pre-clinical animal studies GC021109 has demonstrated a unique, dual mechanism: it both reduces inflammation and reduces amyloid beta, two important factors in the etiology of Alzheimer’s disease. These studies of GC021109 also suggest that it is highly orally bioavailable and has a broad therapeutic window.

“Since its inception GliaCure has pursued an aggressive development timeline yet aimed to be very cost effective, so we are exceptionally pleased that we have been able to move from compound development to first-in-human dosing in less than three years,” said GliaCure President Phil Haydon. “Much of the credit for reaching this milestone has to go to our consultant development team and to our committed investors. Together, they have offered us the resources and expertise to make fast, well thought out decisions to develop a robust study.”

GliaCure’s Phase 1a trial of GC021109 began on September 22. The trial is a randomized, double-blind, placebo-controlled, study of single ascending doses in healthy subjects and is intended to determine the safety, tolerability, and pharmacokinetics of GC021109. 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.

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