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Lighthouse Pharmaceuticals receives a $49.2 million grant from the National Institute on Aging, aimed at advancing a Phase 2 clinical trial of LHP588, a novel gingipain inhibitor targeting Porphyromonas Gingivalis, aimed at slowing Alzheimer's progression in infected patients by addressing a potential microbial cause of neuroinflammation and neurodegeneration
NIA’s grant is aimed to accelerate LHP588 for the treatment of Alzheimer’s disease and Porphyromonas Gingivitis infections.
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Lighthouse Pharmaceuticals announced it received a $49.2 million grant from the National Institute of Aging (NIA), a section of the National Institutes of health (NIH). The grant was awarded to Lighthouse to support the advancement of the Phase 2 clinical trial of LHP588 for patients diagnosed with Alzheimer’s disease and Porphyromonas Gingivitis infections.
"We are honored to receive this support from the NIA. It is powerful validation of the growing body of evidence connecting P. gingivalis to Alzheimer's disease and the potential of gingipain inhibition as a therapeutic strategy," said Casey Lynch, chief executive officer of Lighthouse Pharma. "We are proud to lead this pioneering trial aimed at modifying the disease process by targeting a known microbial driver of neuroinflammation and neurodegeneration."1
LHP588, an orally administered, brain-penetrant lysine-gingipain (Kgp) inhibitor designed to selectively block the activity of this key virulence factor of P. gingivalis, assists in reducing the bacteria's toxicity and viability.1 Previous clinical studies of Kgp inhibitors in mild-to-moderate Alzheimer’s disease patients, yielded significant reduced cognitive decline in designated Porphyromonas Gingivitis subgroups, along with reducing Porphyromonas Gingivitis presence in saliva. These results correlated with improved clinical outcomes.
LHP588 will undergo the Phase 2 Spring trial, evaluating its safety, efficacy, and tolerability of high and low dosage amounts of LHP588, compared to a placebo administered to 300 patients diagnosed with mild to moderate Alzheimer’s disease and have tested positive for Porphyromonas Gingivitis in saliva samples. The Phase 2 trial will be a double-blind, placebo-controlled study. The Phase 2 Spring clinical trial will be supported by NIA under award number R01AG088524.
"This grant enables a rigorous clinical test of a truly novel mechanism of action in Alzheimer's disease," said Marwan Sabbagh MD, chair of Lighthouse Pharma's clinical advisory board. "By directly inhibiting lysine-gingipain, LHP588 offers a targeted approach to intervening in the infectious and inflammatory cascade that may underlie the disease in P. gingivalis-positive AD patients."1
An estimated six million Americans suffer from Alzheimer’s disease, which currently has no cure. Now, emerging evidence showing Porphyromonas Gingivitis infections contribute to the progression of Alzheimer’s through the production of gingipains (neurotoxic proteases that promote inflammation, neuronal damage, amyloid-beta accumulation, and tau pathology).
This positions LHP588 to provide patients diagnosed with Alzheimer’s disease and Porphyromonas Gingivitis infections a treatment solution.
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