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SAN FRANCISCO, February 26, 2025 -- Lighthouse Pharmaceuticals, a clinical-stage pharmaceutical company focused on precision medicine for major unmet medical needs, announced the initiation of a Phase 2 clinical trial of LHP588, the company's next generation gingipain inhibitor, for treatment of P. gingivalis-positive Alzheimer’s disease.

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The SPRING trial, (Stopping PRogression of P. gINGivalis associated Alzheimer's disease), is initially enrolling at Northwest Clinical Research Center in Bellevue, Washington, with plans to expand to additional sites in the future. The study intends to enroll 300 patients with mild to moderate Alzheimer’s dementia and P. gingivalis infection as confirmed by a simple saliva test. The study design leverages key learnings from the first-generation molecule, atuzaginstat, which demonstrated clinical proof-of-concept in a pre-specified group of P. gingivalis-positive subjects in a Phase 2/3 study of mild to moderate dementia patients, slowing cognitive decline by 57% (p = 0.02) over 48 weeks.  

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Previously LHP588 was well tolerated in Phase I SAD/MAD study, with no serious adverse events, no dose-related adverse effects, and no clinically relevant lab findings. 

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About Lighthouse Pharma

Lighthouse is developing novel, potent and selective protease inhibitors based on precision medicine for major unmet medical needs. Our lead program, LHP588, is a next-generation gingipain inhibitor, which precisely blocks gingipain virulence factor toxicity in people with P. gingivalis infection while reducing bacterial load.  In addition to Alzheimer-type dementia, P. gingivalis has been shown to be associated with other degenerative and inflammatory disorders including periodontal disease, cardiovascular disease, and oral cancer.