SciNeuro completes dosing in its Phase 1 clinical trial of SNP318, an oral therapeutic for Alzheimer's disease and other neurodegenerative diseases

2023-11-30

临床1期临床2期

SNP318, a novel, small molecule, orally administered, brain penetrant lipoprotein-associated phospholipase A2 (Lp-PLA2) inhibitor, was well-tolerated in the Phase 1 study.

Inhibition of Lp-PLA2 improves integrity of blood-brain barrier (BBB), that has previously resulted in clinical benefit in Alzheimer's disease (AD)1.

SNP318 Phase 2 study is planned for 2024.

ROCKVILLE, Md., Nov. 30, 2023 /PRNewswire/ -- SciNeuro Pharmaceuticals, a clinical stage biotech company focused on developing treatments for neurodegenerative diseases, particularly Alzheimer's Disease (AD) and Parkinson's Disease (PD), today announced the completion of dosing in its Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose study. The trial was designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of the company's lead clinical asset, SNP318, in healthy participants. Administration of SNP318 was well-tolerated with a favorable exposure, strong target engagement, and excellent safety profile. Additionally, the CNS penetrance and food effects were investigated separately. These results support further development with once daily dosing. A Phase 2 study to assess clinical benefits of SNP318 in stratified AD patients is planned for 2024 as the next step to continue its global development.

"We are delighted to see the scheduled conclusion and informative outcomes of a well planned and executed SNP318 Phase 1 study, thanks to the SciNeuro clinical and translation teams," said Min Li, Ph.D., founder and CEO of SciNeuro Pharmaceuticals. "These results represent a significant step forward in our efforts to further clinical development of SNP318. Our very special gratitude also extends to all the trial participants and dedicated clinical team in Australia. We look forward to continuing our work by addressing neurovascular deficits common among AD to improve the patients' lives affected by these devastating conditions."

Topline

Phase 1 study data summary

SNP318 was safe and well-tolerated with no serious adverse events (SAEs) observed.

Pharmacokinetics and pharmacodynamics data revealed excellent oral exposure supporting for once-daily dosing.

SNP318 has outstanding distribution in the cerebrospinal fluid (CSF) to achieve complete target inhibition in a clinical setting for both peripheral and CNS tissues.

AD and Vascular Pathology

More than 80% AD patients exhibit vascular pathology, a key driver of cognitive decline. While etiology is heterogenous, vascular lesion alone suffices to cause dementia commonly known as vascular dementia. Vascular dementia and AD have considerable overlap. Studying Late-Onset Alzheimer's Disease (LOAD) by following both patients and healthy subjects indicated intra-brain vascular dysfunction is an early and predominant disease development event preceding or independent of amyloid pathology.

About Lp-PLA2

Lp-PLA2 is a phospholipase secreted primarily by inflammatory cells, including peripheral and CNS cells. Lp-PLA2 hydrolyzes oxidized phospholipids, producing lysophosphatidylcholine (LysoPC) and other potent proinflammatory factors. LysoPC is a key mediator of inflammatory stress on brain microvascular endothelial cells resulting in vascular pathology including vessel leakage and other BBB damage.

About SNP318

SNP318 is a potent Lp-PLA2 inhibitor that dampens vascular inflammation, a common pathological feature of multiple neurodegenerative diseases. SNP318 is the only CNS-penetrant Lp-PLA2 inhibitor in clinical development that has been specifically optimized for the treatment of CNS disorders. Therefore, SNP318, independent from anti-amyloid strategy, has the potential to become a new AD therapy.

About SciNeuro Pharmaceuticals

SciNeuro Pharmaceuticals is a clinical-stage biotechnology company focused on developing groundbreaking therapies for neurodegenerative diseases. Since its founding in 2020, SciNeuro has built a portfolio of pipeline programs staged from discovery to clinical development by addressing three key disease-driving mechanisms of neurodegeneration – neurovascular inflammation, proteinopathy, and immune response. The company aims to develop disease-modifying treatment options for Alzheimer's disease, Parkinson's disease, and other devastating CNS diseases. For more information, please visit www.scineuro.com.

Reference:

Maher-Edwards G, De'Ath J, Barnett C, Lavrov A, Lockhart A. A 24-week study to evaluate the effect of rilapladib on cognition and cerebrospinal fluid biomarkers of Alzheimer's disease. Alzheimers Dement (N Y). 2015 Jun 30;1(2):131-140. doi: 10.1016/j.trci.2015.06.003. PMID: 29854933; PMCID: PMC5975052.

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Jessie Yang

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SOURCE SciNeuro Pharmaceuticals