Lighthouse Pharmaceuticals has received a $49.2 million grant from the National Institute on Aging (NIA) — part of the National Institutes of Health (NIH) — to fund its phase 2 trial of the oral Alzheimer’s drug, LHP588.
The SPRING trial will involve 300 patients with confirmed Porphyromonas gingivalis (P. gingivalis) bacterial infections and mild to moderate Alzheimer’s disease in a double-blind, placebo-controlled study. In addition to being a keystone pathogen in chronic periodontitis, P. gingivalis appears to play a role in cognitive decline and chronic systemic inflammation.
LHP588 is an orally-available, brain-penetrant lysine-gingipain (Kgp) inhibitor. It decreases the toxicity and viability of P. gingivalis by blocking the activity of the bacterium. In an earlier study of patients with mild to moderate AD, it significantly slowed cognitive decline in the subgroup with P. gingivalis infections. In addition, the trial found a significant correlation between a reduction in P. gingivalis in saliva and improved clinical outcomes. The clinical trial will assess the safety, efficacy, and tolerability of LHP588.