NeuroSense's PrimeC Shows Enhanced Neuroplasticity in Alzheimer's Patient-Derived Neurons
Key Insights
NeuroSense Therapeutics reported positive initial results from its Phase 2 RoAD trial, showing that PrimeC treatment enhanced neuroplasticity (search) in patient-derived neurons from Alzheimer's disease (search) patients.
The study utilized NeuroKaire (search)'s proprietary technology to generate brain cells from patient blood samples, demonstrating improved brain-cell connectivity and health with no treatment-related toxicity.
PrimeC is a novel oral combination of ciprofloxacin and celecoxib designed to target multiple mechanisms underlying neurodegeneration in Alzheimer's disease (search).
NeuroSense Therapeutics announced positive initial results from its ongoing Phase 2 RoAD clinical trial evaluating PrimeC for Alzheimer's disease (search), demonstrating enhanced neuroplasticity (search) in patient-derived neurons with a favorable safety profile. The findings represent a significant step forward in precision medicine approaches to neurodegenerative disease treatment.
Novel Patient-Derived Neuron Platform Reveals Therapeutic Activity
The collaboration between NeuroSense and NeuroKaire (search) utilized an innovative approach to assess PrimeC's effects on disease-relevant human neurons. NeuroKaire's proprietary technology reprograms blood sample cells into induced pluripotent stem cells (iPSCs) and differentiates them into mature human cortical neurons. After validation, neurons are exposed to PrimeC, and advanced high-content imaging using AI-driven analytics quantifies key features of neuronal structure.
Analysis of samples from clinically characterized Alzheimer's disease (search) patients demonstrated that PrimeC treatment enhanced neuroplasticity (search), a key feature in supporting brain health and function and underlying memory formation and retention. Importantly, no treatment-related toxicity was observed, demonstrating the safety of the PrimeC combination.
"This is exactly the kind of early, decision-enabling signal RoAD was designed to uncover," stated Alon Ben-Noon, CEO of NeuroSense. "By integrating NeuroKaire (search)'s patient-derived neuron platform with our clinical program, we observed measurable gains in brain-cell connectivity and a favorable safety profile. These findings strengthen PrimeC's mechanistic rationale in Alzheimer's and enable us to focus development with greater precision."
Phase 2 Trial Design and Mechanistic Approach
The RoAD study is a randomized, double-blind, placebo-controlled Phase 2 trial enrolling mild-to-moderate Alzheimer's disease (search) patients, designed to evaluate safety, efficacy, and biological activity of PrimeC over 12 months. These initial results provide an early, patient-specific view of how PrimeC may affect disease-relevant human neurons, reinforcing the program's mechanistic rationale and guiding precision development in Alzheimer's disease.
PrimeC, NeuroSense's lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. The compound is designed to synergistically target several key mechanisms of ALS and Alzheimer's disease (search) that contribute to neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid (RNA) regulation to potentially inhibit disease progression.
Addressing Significant Unmet Medical Need
Alzheimer's disease (search) is a progressive neurodegenerative disorder and the leading cause of dementia worldwide, affecting more than 30 million people globally. The disease is characterized by memory loss, cognitive decline, and behavioral changes, and currently has no cure. Existing therapies provide only limited symptomatic relief, leaving a significant unmet need for disease-modifying treatments that can slow or halt progression.
Dr. Daphna Laifenfeld, CSO of NeuroKaire (search), commented: "Our platform is designed to detect subtle, disease-relevant changes in human neurons with the sensitivity modern drug development requires. This collaboration demonstrates how a bench-to-clinic 360° workflow can transform a simple blood draw into actionable, patient-specific insights, accelerating innovation for people living with AD."
Future Development and Data Timeline
The technology generates composite response profiles tied to neuroplasticity (search), connectivity, and cell health, providing researchers with detailed insights into therapeutic mechanisms. These results will be presented at the CNS Summit 2025 in Boston, November 2nd – 5th by David Pattison, VP Business Development at NeuroKaire (search).
NeuroSense and NeuroKaire (search) will continue evaluating PrimeC's cellular effects in parallel with clinical outcomes from the RoAD trial, with top-line data expected following study completion. Given the complexity of Alzheimer's disease (search), approaches that target multiple disease mechanisms simultaneously, such as PrimeC, hold potential to deliver meaningful therapeutic advances for patients and their families.