Lighthouse Pharmaceuticals Announces FDA Approval To Proceed With Phase 2 Spring Trial Of LHP588, A Next-Generation Treatment For P. Gingivalis-positive Alzheimer’s Disease
Phase 1 single ascending and multiple ascending dose studies previously completed demonstrate safety, tolerability and dosing to reach optimal target engagement
Excerpt from the Press Release:
SAN FRANCISCO, Nov. 16, 2023 /PRNewswire/ — Lighthouse Pharmaceuticals, a clinical-stage biopharmaceutical company pioneering precision medicine for the treatment of Alzheimer’s and other diseases of aging, today announced clearance by the U.S. Food and Drug Administration (FDA) of the Investigational New Drug (IND) application for LHP588, the company’s next-generation gingipain inhibitor, for the treatment of P. gingivalis-positive Alzheimer’s disease.
The “Study May Proceed” letter from the FDA was based on review of the comprehensive IND package including safety, chronic toxicology, manufacturing, Phase 1 human data, and the planned Phase 2 SPRING (Stopping PRogression of P. gINGivalis-positive Alzheimer’s disease) trial protocol. LHP588 is a next-generation, brain penetrant small-molecule gingipain inhibitor that demonstrated safety and tolerability in the completed Phase 1 study, along with plasma levels sufficient to engage the target with just once-daily oral dosing.
The Phase 2 SPRING clinical trial is a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of once-a-day dosing of LHP588 for the treatment of P. gingivalis-positive mild to moderate Alzheimer’s disease. 300 patients will be enrolled in the trial and randomized into three arms (placebo, 25 and 50 mg) for 48 weeks of treatment. Patients must have mild to moderate Alzheimer’s disease and evidence of P. gingivalis infection, based on a saliva test.
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