The Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for LHP588 (Lighthouse Pharmaceuticals; San Francisco, CA), a next-generation small-molecule gingipain inhibitor under investigation as a potential treatment for Porphyromonas gingivalis–positive Alzheimer disease (AD). LHP588 is designed to target the infectious P. gingivalis pathogen that is associated with some chronic degenerative and inflammatory disorders, including AD.

The IND clearance was based on data from a phase 1 trial in humans, which demonstrated that LHP588 met safety and tolerability endpoints, while also showing plasma levels sufficient for engaging the P. gingivalis target with once-daily dosing. In addition to the clearance, the FDA provided a “Study May Proceed” letter, enabling LHP588 to initiate a planned phase 2 clinical trial called SPRING. SPRING will be a randomized, double-blind, placebo-controlled study assessing the safety and efficacy of once-daily LHP588 as a treatment for P. gingivalis–positive mild to moderate AD.

“LHP588 is a next-generation gingipain inhibitor that has been optimized for selectivity and metabolism, demonstrating an excellent safety profile in both human and toxicology studies,” Casey Lynch, CEO of Lighthouse Pharmaceuticals. “With FDA clearance in hand, we look forward to working with our clinical advisors and investors to move this important clinical study forward.”