SciNeuro Pharmaceuticals, a biotech company in the clinical stage, has successfully concluded dosing in its Phase 1 study, focusing on the development of treatments for neurodegenerative diseases, such as Alzheimer's Disease (AD) and Parkinson's Disease (PD). The randomized, double-blind, placebo-controlled trial aimed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of their leading clinical candidate, SNP318, in healthy participants. The administration of SNP318 demonstrated positive results, including favorable exposure, strong target engagement, and an excellent safety profile. Separate investigations into CNS penetrance and food effects were carried out, supporting the potential for further development with once-daily dosing. The company plans to initiate a Phase 2 study in 2024 to evaluate the clinical benefits of SNP318 in stratified AD patients.

Min Li, Ph.D., the founder and CEO of SciNeuro Pharmaceuticals, expressed satisfaction with the well-executed Phase 1 study, acknowledging the informative outcomes and commending the efforts of the SciNeuro clinical and translation teams. Dr. Li extended gratitude to trial participants and the dedicated clinical team in Australia, emphasizing the company's commitment to addressing neurovascular deficits associated with AD to improve the lives of affected patients.

Key findings from the Phase 1 study include:

• SNP318 was safe and well-tolerated, with no serious adverse events observed.
• Pharmacokinetics and pharmacodynamics data revealed excellent oral exposure, supporting the feasibility of once-daily dosing.
• SNP318 demonstrated outstanding distribution in the cerebrospinal fluid (CSF), achieving complete target inhibition in both peripheral and CNS tissues in a clinical setting.

The announcement also highlighted the prevalence of vascular pathology in AD patients, with more than 80% exhibiting such issues. Vascular pathology is a significant contributor to cognitive decline, and SciNeuro Pharmaceuticals aims to address this aspect in their ongoing research. The company provided insights into Late-Onset Alzheimer's Disease (LOAD), emphasizing the role of intra-brain vascular dysfunction as an early and predominant event in disease development.

Additionally, the release provided background information on Lp-PLA2 (lipoprotein-associated phospholipase A2), an enzyme associated with inflammatory processes in peripheral and CNS cells. The company's lead candidate, SNP318, was described as a potent Lp-PLA2 inhibitor designed to mitigate vascular inflammation, a common pathological feature in various neurodegenerative diseases. Notably, SNP318 is the only CNS-penetrant Lp-PLA2 inhibitor in clinical development, offering a unique therapeutic approach independent of anti-amyloid strategies for the potential treatment of AD.

 

Source: prnewswire.com

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