Melbourne, Australia — Denteric today announced the commencement of participant recruitment for a Phase I clinical study of its first-in-class therapy for Alzheimer's disease.
Alzheimer's disease remains one of the greatest medical challenges of our time and with an aging population this will only increase. Approximately 38 million people globally and 7 million in the US alone live with Alzheimer's disease.
A growing body of research links the progression of Alzheimer's disease with exposure to chronic bacterial and viral infections. Porphyromonas gingivalis, a bacterium that commonly infects tooth pockets and causes chronic inflammation, has been shown to release toxic proteins (gingipains) that travel to the brain, where they may contribute to the development of Alzheimer's disease. Denteric's therapy is envisaged to stimulate the immune system to eliminate gingipains and remove the upstream driver of inflammation.
The randomised, double-blind study (see ANZCTR) will recruit 10 patients with early Alzheimer's disease and who are positive for Porphyromonas gingivalis in saliva. It will investigate the safety and the ability of the therapy to stimulate immune responses directed against the gingipains. The first site to commence recruitment is the Royal Melbourne Hospital, with a second site at Austin Health expected to open soon.
"Commencing recruitment for this Phase I study represents an important step in advancing our broader gingipain and chronic inflammation platform approach" says Sean McLoughlin, CEO. "This early-stage trial is focused on evaluating GPV381 safety and tolerability in patients with P. gingivalis infection, which is a necessary foundation before any future studies assessing clinical outcomes."
The study is supported by a grant from CUREator+ Dementia and Cognitive Decline and the Australian Government's Medical Research Future Fund.
About Denteric Denteric is a clinical-stage biotechnology company developing immunotherapeutic approaches to address the underlying biological drivers of chronic inflammatory diseases.
About GPV381
GPV381 is a first-in-class therapeutic designed to generate antibodies targeting gingipain toxins produced by Porphyromonas gingivalis, a bacterium known to cause gum disease. By addressing upstream drivers of immune dysregulation, GPV381 is intended to enable a disease-modifying approach to the treatment of P. gingivalis-related diseases including Alzheimer's disease and periodontitis.
