The study will assess the safety and immune-stimulating ability of an inflammation-reducing therapy.
Clinical-stage biotechnology company Denteric has recruited the first participant in its phase 1 study of GPV381, a potential first-in-class therapy for Alzheimer’s disease.
GPV381 is a novel therapeutic candidate that produces antibodies against gingipain toxins produced by the bacterium Porphyromonas gingivalis, which cause gum disease. Research suggests the gingipain toxins travel to the brain and play a role in the development of Alzheimer’s disease through their pro-inflammatory properties.
The randomised, double-blind trial will involve 10 patients with early Alzheimer’s disease who also have P. gingivalis in their saliva. Eight of these patients will receive three doses of GPV381 by intramuscular injection across a two-month period, with the remaining two patients receiving a placebo injection. Participants will be followed up one week after each dose, as well as at three and four months after the initial dose.
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Recruitment is currently underway at the Royal Melbourne Hospital. The company plans to also recruit patients from an Austin Health site in the near future.
Denteric CEO Sean McLoughlin was pleased the trial had kicked off.
“Commencing recruitment for this Phase I study represents an important step in advancing our broader gingipain and chronic inflammation platform approach,” he said in a statement. “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 phase 1 study is funded by a CUREator+ Dementia and Cognitive Decline grant and the federal government’s Medical Research Future Fund.
