Lighthouse Pharmaceuticals, a clinical-stage biopharmaceutical company pioneering precision therapies for neurodegenerative diseases, announced on Friday that it has been awarded a USD49.2m grant from the National Institute on Aging (NIA), part of the National Institutes of Health (NIH), to support a Phase 2 clinical trial of LHP588 in Alzheimer's disease (AD) patients with a confirmed Porphyromonas gingivalis (P. gingivalis) infection.

P. gingivalis is best known for its role as a keystone pathogen in chronic periodontitis and has been implicated in chronic systemic inflammation and cognitive decline.

LHP588 is an orally available, brain-penetrant lysine-gingipain (Kgp) inhibitor designed to selectively block the activity of this key virulence factor of P. gingivalis, thereby reducing the bacteria's toxicity and viability. A previous clinical study of a Kgp inhibitor in mild to moderate AD showed significant slowing of cognitive decline in the prespecified P. gingivalis-positive subgroup and P. gingivalis reduction in saliva correlated significantly with improved clinical outcome measures.

The Phase 2 SPRING Trial will evaluate the safety, tolerability, and efficacy of a high and low dose of LHP588 compared to placebo in 300 patients with mild to moderate AD and a positive saliva test for P. gingivalis in a randomized, double-blind, placebo-controlled design.