The trial will enrol 300 patients with P. gingivalis-positive Alzheimer’s disease. Credit: Robert Kneschke / Shutterstock.com.

Lighthouse Pharmaceuticals has obtained the US Food and Drug Administration (FDA) clearance for its investigational new drug (IND) application to commence a Phase II clinical trial of LHP588 for P. gingivalis-positive Alzheimer’s disease.

The regulatory agency provided a ‘Study May Proceed’ letter to the company following its review of a complete IND package. 

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Chronic toxicology, safety, production, Phase I human trial data as well as the protocol for the prospective Phase II SPRING trial were part of the package. 

The double-blind, randomised, placebo-controlled trial will evaluate the safety and efficacy of a once-daily dose of LHP588 to treat P. gingivalis-positive mild to moderate Alzheimer’s disease. 

It will enrol 300 subjects who will be randomised into three arms to receive 25 or 50mg LHP588 or placebo for 48 weeks. 

See Also:

A next-generation, brain-penetrant small-molecule inhibitor of gingipain, LHP588 showed safety and tolerability in a previously concluded Phase I trial.

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Data from the GAIN trial in mild to moderate AD patients with a positive P. gingivalis showed that another gingipain inhibitor, atuzaginstat, offered a dose-dependent 57% reduction in cognitive decline versus a placebo.

Lighthouse Pharmaceuticals CEO Casey Lynch said: “The clinical efficacy and safety data provided by the GAIN trial has enabled us to significantly de-risk the mechanism of action, maximise target engagement with higher exposures of LHP588, and implement the optimal clinical study design. 

“LHP588 is a next-generation gingipain inhibitor that has been optimised for selectivity and metabolism, demonstrating an excellent safety profile in both human and toxicology studies.”