Lighthouse Pharmaceuticals received a $49.2 million grant from the National Institute on Aging (NIA) to support a Phase 2 clinical trial of LHP588 for Alzheimer’s disease in patients with confirmed Porphyromonas gingivalis infection, according to the company.
LHP588 is an orally administered, brain-penetrant lysine-gingipain (Kgp) inhibitor intended to block a key virulence factor of P. gingivalis, reducing the bacterium’s toxicity and activity. A prior study involving a Kgp inhibitor in mild to moderate Alzheimer’s patients who tested positive for P. gingivalis reportedly showed slowed cognitive decline and reduced bacterial levels in saliva, which correlated with improved outcomes.
The upcoming Phase 2 “SPRING” trial will enroll 300 patients with mild to moderate Alzheimer’s disease and a positive saliva test for P. gingivalis. The randomized, double-blind, placebo-controlled study will compare high and low doses of LHP588 against placebo to assess safety, tolerability, and efficacy.
This funding represents a significant federal endorsement of the emerging link between microbial factors and Alzheimer’s progression, and aims to test a targeted therapeutic strategy against an infection-associated driver of neurodegeneration.
