Lighthouse Pharmaceuticals, a clinical-stage biopharmaceutical company focused on precision medicine for Alzheimer's and other age-related diseases, has announced that the U.S. Food and Drug Administration (FDA) has granted clearance for its Investigational New Drug (IND) application for LHP588. This next-generation gingipain inhibitor is intended for the treatment of Alzheimer's disease associated with P. gingivalis infection.

The FDA's "Study May Proceed" letter follows a thorough review of the comprehensive IND package, which included assessments of safety, chronic toxicology, manufacturing, Phase 1 human data, and the proposed Phase 2 SPRING (Stopping PRogression of P. gINGivalis-positive Alzheimer's disease) trial protocol. LHP588, characterized as a brain-penetrant small-molecule gingipain inhibitor, demonstrated safety and tolerability in the completed Phase 1 study, with plasma levels adequate for target engagement through once-daily oral dosing.

The upcoming Phase 2 SPRING clinical trial is designed as a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of once-a-day dosing of LHP588 in treating mild to moderate Alzheimer's disease associated with P. gingivalis infection. The trial will enroll 300 patients who will be randomized into three arms (placebo, 25 mg, and 50 mg) for a 48-week treatment period. Eligible patients must exhibit mild to moderate Alzheimer's disease and evidence of P. gingivalis infection based on a saliva test. Notably, the GAIN trial involving the first-generation gingipain inhibitor, atuzaginstat, demonstrated a dose-dependent 57% reduction in cognitive decline, as measured by the prespecified proof of efficacy endpoint ADAS-Cog11, in patients with mild to moderate Alzheimer's disease and a positive P. gingivalis saliva test, compared to the placebo group.

Lighthouse Pharmaceuticals, expressed satisfaction with FDA clearance for the SPRING Phase 2 clinical trial, highlighting the promising results of previous studies on this mechanism. The positive clinical efficacy and safety data from the GAIN trial have contributed to de-risking the mechanism of action, optimizing target engagement with higher exposures of LHP588, and implementing an optimal clinical study design. Lynch emphasized that LHP588, as a next-generation gingipain inhibitor, has been fine-tuned for selectivity and metabolism, demonstrating an excellent safety profile in both human and toxicology studies. With FDA clearance secured, the company is eager to collaborate with clinical advisors and investors to advance this crucial clinical study.

 

Source: prnewswire.com

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