Rilapladib

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 . 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. SciNeuro Media Contact Jessie Yang [email protected] SOURCE SciNeuro Pharmaceuticals

SHANGHAI and ROCKVILLE, Md., June 1, 2022 /PRNewswire/ -- SciNeuro Pharmaceuticals (SciNeuro), a leader in the discovery and development of innovative therapeutics for the treatment of CNS diseases, today announced the execution of an exclusive, worldwide license and option agreement with GlaxoSmithKline (GSK). The agreement focuses on inhibitors of Lp-PLA2, an enzyme that has been implicated in the pathogenesis of neurodegenerative diseases. Clinical findings suggest that inhibition of Lp-PLA2 activity may improve cognitive function in subjects with Alzheimer's disease.1 Under the agreement, SciNeuro will receive a worldwide license to intellectual property covering certain GSK Lp-PLA2 inhibitors and will be responsible for their further development through clinical proof-of-concept (PoC). Following the completion of the PoC studies, GSK has the option to reclaim rights to the compounds in all territories excluding Greater China, which SciNeuro would retain, under pre-agreed terms for subsequent development and commercialization. SciNeuro will pay an upfront fee, near-term and downstream milestones, and royalties to GSK. If GSK exercises its option, SciNeuro will receive an option exercise fee, downstream milestones, and royalty payments from GSK. In addition, GSK will have a right to purchase equity in SciNeuro. "We are excited to further the development of these novel Lp-PLA2 inhibitors. Given the critical role of Lp-PLA2 in CNS integrity and the demonstrated human pharmacology of Lp-PLA2 inhibition, we look forward to evaluating the clinical benefit of these Lp-PLA2 inhibitors in the treatment of CNS diseases," said Min Li, Ph.D., Founder and CEO of SciNeuro Pharmaceuticals. "We are pleased to enter into this agreement with SciNeuro that allows us to assess the clinical potential of these Lp-PLA2 inhibitors by leveraging SciNeuro's early development expertise in CNS disease," said John Lepore, M.D., SVP and Head of Research, at GSK. "This agreement enables us to focus on progressing our own internal assets, while maintaining pipeline optionality for the development of these Lp-PLA2 inhibitors in the future." About SciNeuro Pharmaceuticals SciNeuro Pharmaceuticals is an innovation-driven, neuroscience-focused biopharmaceutical company with an established pipeline of novel therapeutic candidates to address neurodegenerative and other CNS diseases. The company focuses on targets that are supported by human biology and which play a critical role in regulating foundation biology, to achieve better probability of success in clinical development. SciNeuro is committed to delivering medicines that can make a difference to improve the lives of patients around the world, transforming scientific discoveries into groundbreaking therapies. To learn more, visit . SciNeuro Media Contact: Jessie Yang, jessie.yang@scineuro.com 1 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;1(2):131-140.