Lighthouse Pharmaceuticals has secured a grant of $49.2m from the National Institute on Aging (NIA), a division of the National Institutes of Health (NIH), to facilitate a Phase II study of LHP588 for Alzheimer’s disease (AD).
This trial will focus on patients diagnosed with AD who also test positive for Porphyromonas gingivalis (P. gingivalis), a bacterium associated with chronic periodontitis and linked to systemic inflammation and cognitive decline.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
LHP588 functions as a lysine-gingipain (Kgp) inhibitor, targeting the virulence factors of P. gingivalis to mitigate its harmful effects.
Previous studies involving a Kgp inhibitor indicated a notable reduction in cognitive decline among patients with mild to moderate AD, particularly in those with confirmed P. gingivalis infections, according to the company.
Lighthouse Pharma CEO Casey Lynch said: “We are honoured 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.”
The upcoming Phase II SPRING Trial will assess the tolerability, safety and efficacy of two dosage levels of LHP588 against a placebo in 300 participants with mild to moderate disease and positive saliva tests for P. gingivalis.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataLighthouse Pharma’s clinical advisory board chair Marwan Sabbagh said: “This grant enables a rigorous clinical test of a truly novel mechanism of action in Alzheimer’s disease.
“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.”
AD currently impacts more than six million individuals in the US, with no established cure.
Research indicates that chronic P. gingivalis infection may exacerbate Alzheimer’s progression through the release of gingipains, which are neurotoxic proteases that can lead to inflammation, neuronal damage, and the accumulation of amyloid-beta and tau proteins.
