SciNeuro Pharmaceuticals is aiming to resurrect a previous GSK Alzheimer’s disease program with a new Phase I study.
The biotech has initiated a Phase I trial of SNP318 (NCT05792163), a LpPLA2 inhibitor designed to provide anti-inflammatory effects in a variety of neurodegenerative diseases. SciNeuro had acquired the intellectual property covering GSK’s Lp-PLA2 inhibitor pipeline through the proof-of-concept stage, the company announced in June 2022.
GSK previously investigated its Lp-PLA2 inhibitor rilapladib in a 124-patient trial in Alzheimer’s disease (NCT01428453). The study demonstrated a statistically significant improvement in the Working Memory/Executive Function (WM/EF) scale, though there was not a statistically significant affect along a biomarker measuring amyloid-beta levels.
However, SNP318 is more potent than GSK’s molecules, giving SciNeuro more development options in the central nervous system (CNS) disease space, CEO Min Li told Clinical Trials Arena. SciNeuro has not yet announced specific CNS target indications for later-stage studies of SNP318. But given GSK’s previous research, patients with Alzheimer’s disease, patients with vasculature deficits, and patients with cognitive deficits are potential starting points, Li said.
Before founding SciNeuro in 2020, Li worked in GSK’s research and development program for five years. The biotech is based in Rockville, Maryland and Shanghai, China.
SciNeuro’s Phase I program
The Phase I trial of SNP318 is currently recruiting 86 healthy subjects in a 20-day study based in Australia. SciNeuro chose to run the study out of Australia because the country has a history of regulatory efficiency, and data produced in Australia is recognized in global jurisdictions, Li explained.
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As a primary endpoint, the trial investigates the number of adverse events over 20 days. Secondary endpoints include pharmacokinetic outcomes and a measure of SNP-318 concentration in cerebrospinal fluid.
SNP318 inhibits the enzyme Lp-PLA2, which can damage endothelial cells within blood vessels in the disease state through an inflammatory pathway. All neurodegenerative diseases have a vasculature component, so in principle, SNP318 is anti-inflammatory and will be beneficial in a variety of neurodegenerative diseases, Li said.