LHP588 / Lighthouse Pharma - LARVOL DELTA

Study of LHP588 in Subjects with P. Gingivalis-Positive Alzheimer's Disease (clinicaltrials.gov) - P2 | N=300 | Recruiting | Sponsor: Lighthouse Pharmaceuticals, Inc.

New P2 trial • Alzheimer's Disease • CNS Disorders

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 (PRNewswire) - "Lighthouse Pharmaceuticals...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 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."

IND • New P2 trial • Alzheimer's Disease • CNS Disorders

Phase 1 SAD/MAD data and Phase 2 study design for LHP588, a second-generation gingipain inhibitor for the treatment of P. gingivalis-positive Alzheimer's dementia (CTAD 2023) - P1, P2/3 | "LHP588 was well-tolerated in healthy volunteers without evidence of hepatic safety signals to date, and its PK profile was supportive of once daily dosing. The Phase 2 trial of LHP588 will be similar in design to the prior atuzaginstat study but will be restricted to subjects with Pg+ saliva. gingivalis, Alzheimer’s."

P1 data • P2 data • Alzheimer's Disease • CNS Disorders • Dementia • Developmental Disorders • Infectious Disease • Inflammation

Phase 2 Study Design and New Data from the Phase 1 SAD/MAD Trial of LHP588, A Second-Generation Gingipain Inhibitor for the Treatment of P. Gingivalis - Positive Alzheimer Dementia (AAIC 2023) - "Conclusion : LHP588 was well-tolerated in healthy volunteers without evidence of hepatic safety signals to date, and its PK profile was supportive of once daily dosing. The Phase 2 trial of LHP588 proposed to start in late 2023 will be similar in design to the prior atuzaginstat study but will be restricted to subjects with Pg + saliva."

New P1 trial • P1 data • P2 data • Alzheimer's Disease • CNS Disorders • Dementia • Infectious Disease • Inflammation • Targeted Protein Degradation

Lighthouse Pharmaceuticals Announces Presentation at the 2023 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting (PRNewswire) - P1 | N=64 | NCT04920903 | Sponsor: Cortexyme Inc. | "Lighthouse Pharmaceuticals...announced the upcoming presentation of new data and strategic plans in a Plenary Presentation during the Pharmaceutical Pipeline session. The accepted abstract, entitled 'Phase 2 Study Design and New Data from the Phase 1 SAD/MAD Trial of LHP588, a Second-Generation Gingipain Inhibitor for the Treatment of P. Gingivalis-Associated Dementia,' will share new data related to the single ascending dose (SAD) and multiple ascending dose (MAD) trials of LHP588. Additionally, the design and clinical efficacy data supporting the planned Phase 2b SPRING (Stopping PRogression of Porphyromonas gINGivalis associated Alzheimer's disease) Trial will be shared."

New P2b trial • P1 data • Alzheimer's Disease • CNS Disorders

Lighthouse Pharmaceuticals Announces Progression of LHP588 Clinical Development Program in Alzheimer’s Disease - "Lighthouse Pharmaceuticals, a clinical-stage pharmaceutical company developing therapeutics to alter the course of dementia and other degenerative diseases, announced completion of a Pre-investigational New Drug (PIND) meeting with the Food and Drug Administration (FDA) related to the planned Phase 2b clinical study of LHP588 and the formation of its Clinical Advisory Board (CAB). The CAB includes six members with diverse backgrounds and expertise in dementia, Alzheimer's disease, inflammation, neurodegenerative disorders, and drug development: Marwan Sabbagh, M.D...Jeffrey Cummings, M.D..."

Lighthouse Pharmaceuticals Announces Progression of LHP588 Clinical Development Program in Alzheimer’s Disease (PRNewswire) - "Lighthouse Pharmaceuticals...announced completion of a Pre-investigational New Drug (PIND) meeting with the Food and Drug Administration (FDA) related to the planned Phase 2b clinical study of LHP588 and the formation of its Clinical Advisory Board (CAB). The CAB includes six members with diverse backgrounds and expertise in dementia, Alzheimer's disease, inflammation, neurodegenerative disorders, and drug development: Marwan Sabbagh, M.D., Merce Boada, M.D., Jeffrey Cummings, M.D., Clive Holmes, M.D., Mark Ryder, D.M.D., and Lon Schneider, M.D."

FDA event • Alzheimer's Disease • CNS Disorders

Cortexyme Successfully Completes Phase 1 Single and Multiple Ascending Dose Clinical Trial of COR588 (Businesswire) - “Cortexyme, Inc…reported the successful completion of its Phase 1 single ascending dose and multiple ascending dose (SAD/MAD) clinical trial of COR588…The study was a randomized, double-blind, placebo-controlled, first-in-human study to evaluate the safety, tolerability, and pharmacokinetics of COR588 in healthy adult participants.”

Trial status • Alzheimer's Disease • CNS Disorders

A Single and Multiple Ascending Dose Study of COR588 (clinicaltrials.gov) - P1 | N=64 | Completed | Sponsor: Cortexyme Inc. | Recruiting ➔ Completed

Trial completion

Cortexyme Charts New Course with Acquisition of Rare Disease Player (BioSpace) - “Cortexyme’s pipeline ranges from Alzheimer’s to periodontal disease…and its website indicates plans to initiate a Phase II trial of its COR588, also a Kgp inhibitor, in Alzheimer’s disease in the second half of this year.”

New P2 trial • Alzheimer's Disease • CNS Disorders

Increased levels of phospho-tau217 in neuron cultures and CVN mice infected with Porphyromonas gingivalis. (PubMed, Alzheimers Dement) - "P. gingivalis infected neuronal cell cultures and chronically infected CVN mice display elevated p-tau217. In vitro this was apparent at low infection levels that might reflect the physiological level of gingipain exposure. Phospho-tau217 is emerging as a specific biomarker for AD and these results further validate P. gingivalis-infected neuron cultures and mice as models for AD."

Journal • Preclinical • Alzheimer's Disease • CNS Disorders • Infectious Disease • NOS2