GliaCure Completes Successful Proof of Concept Phase 1b Clinical Trial in Alzheimer’s Disease
GliaCure, a privately-held biotechnology company focused on the development of novel therapies for neurological and neuropsychiatric disorders based on glial targets, announced yesterday that it has successfully completed a Phase 1b clinical trial of its lead product candidate, GC021109, a compound developed as a disease-modifying treatment for Alzheimer’s disease. The trial, which began in February 2015, included multiple ascending doses of drug in 36 patients with mild to moderate Alzheimer’s disease. The trial was intended to demonstrate the safety and tolerability of GC021109 and to measure key biomarkers of Alzheimer’s disease. GliaCure reported that the pooled trial results showed a statistically significant change in amyloid β in the cerebrospinal fluid of subjects dosed with drug compared to placebo, potentially demonstrating GC021109’s usefulness in treating Alzheimer’s disease.
“We are very excited to find that, as predicted by our Phase 1a study in healthy volunteers, GC021109 is both safe and well tolerated,” said GliaCure President Phil Haydon. “And although this was a small sample size, we are highly encouraged by the results of our measurements of biomarkers, including amyloid β.”
Added GliaCure board member Joseph Zakrzewski, “At the beginning of the year GliaCure made an ambitious commitment: that we would complete a Phase 1 proof of concept clinical trial in patients by the end of 2015. As a company and a board we are pleased that the team has fulfilled this commitment, and with such positive results.”
GliaCure’s approach to treating Alzheimer’s disease is novel in that it promotes both the clearance of amyloid and stimulates anti-inflammatory actions through a single target. The company is currently developing plans for a Phase 2 clinical trial in Alzheimer’s disease patients to begin studying the efficacy of GC021109.