A Boston-based private biotech company has revealed it has begun the first-in-human clinical trial for one of their leading pipeline products for Alzheimer’s disease — the most common form of dementia that affects over 5 million Americans today, and is the cause of more than 500,000 deaths among older adults every year.
GliaCure, true to their specialization in developing solutions for neurological and neuropsychiatric disorders, has started administering GC021109 to healthy participants in their Phase 1a clinical trial. This study’s advancement follows promising results from their pre-clinical studies on animal models, which showed the formulation’s ability to lessen inflammation and amyloid beta — two chief determinants of Alzheimer’s. Another interesting point of this study is that GC021109 is likely to be stable when taken orally, and can sustain a longer half-life.
This newly-started study is randomized, double-blind, and placebo-controlled. It involves healthy participants, receiving single ascending doses of the product in order to determine its initial safety, subject tolerance, and mode of action. Ongoing are the company’s plans for the subsequent Phase 1b study, which will introduce multiple ascending doses in patients with Alzheimer’s disease.
The president of the company and Chair of Neuroscience at Tufts University, Philip G. Haydon, said GC021109 has gone through rapid development while yielding impressive results on a reasonable budget. Thanks to the funding from GliaCure’s investors, the product has gone from inception to human dosing in just 3 years time, with the Phase 1a trial having only started September 22, 2014. Additionally, the company believes this product has the potential to address inflammatory processes in other diseases such as psoriasis, Parkinson’s disease, and multiple sclerosis.
A recent finding from a research conducted at the University of Kentucky’s Sanders-Brown Center on Aging showed that patients’ self-reports on memory loss or forgetfulness may be indicative of Alzheimer’s disease even years before characteristic symptoms appear.