NeuroSense Collaborates with PhaseV to Enhance ALS Phase 3 Trial Using Advanced Machine Learning

NeuroSense Therapeutics, a biotechnology firm listed on Nasdaq, has revealed a partnership with PhaseV, a leader in causal machine learning (ML) for clinical trial optimization. This collaboration aims to enhance the design and outcomes of NeuroSense's upcoming Phase 3 trial of PrimeC, a drug developed for amyotrophic lateral sclerosis (ALS).

PhaseV conducted an independent analysis utilizing causal ML on NeuroSense's Phase 2b trial data, known as the PARADIGM study. The analysis predicts a high likelihood of success across multiple patient subgroups in the forthcoming Phase 3 trial of PrimeC. This crucial insight is expected to significantly influence the trial’s design, patient recruitment, and overall cost-efficiency.

CEO of NeuroSense, Alon Ben-Noon, emphasized the urgent need for innovative approaches to address ALS, a debilitating neurodegenerative disease. He expressed optimism based on recent subgroup analyses from the PARADIGM trial, which showed promising potential for PrimeC. Ben-Noon highlighted the value added by PhaseV's insights, which will be applied to optimize the Phase 3 study, aiming to achieve meaningful and differentiated clinical results. NeuroSense intends to continue this collaboration throughout the Phase 3 trial development.

NeuroSense's PARADIGM Phase 2b trial reported positive results regarding the efficacy and safety of PrimeC. The drug demonstrated a statistically significant 37% reduction in disease progression, as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R) score (p=0.03) in the per-protocol population. Additionally, among high-risk ALS patients, PrimeC showed a 43% reduction in disease progression (p=0.02) compared to placebo after six months of treatment. This translated to a 5.04 points difference on the ALSFRS-R scale in favor of PrimeC (Confidence Interval: 0.862, 9.214; n=38). High-risk patients, as defined by the European Network for the Cure of ALS (ENCALS) Risk Factor, constitute approximately half of the ALS population.

NeuroSense plans to submit its End of Phase 2 package to the FDA and EMA in the near future, including an updated Phase 3 study protocol to be discussed in upcoming meetings.

Dr. Raviv Pryluk, CEO and Co-founder of PhaseV, noted the limited therapeutic options available for ALS due to its complex and heterogeneous nature. He emphasized that PrimeC had shown great promise in its Phase 2b study. PhaseV's unique combination of causal-ML, real-world data, and advanced statistical methods confirmed the potential clinical benefits of PrimeC and offered actionable insights for the Phase 3 study. Their analysis predicted a high success rate for PrimeC in various subgroups recommended for the Phase 3 trial.

PhaseV specializes in addressing the challenges of drug development by identifying the subgroups and endpoints most likely to succeed in clinical trials. This expertise helps companies optimize their Phase 3 trial designs to achieve successful outcomes.

NeuroSense Therapeutics is a clinical-stage company focused on developing treatments for severe neurodegenerative diseases such as ALS, Alzheimer’s, and Parkinson’s. The company aims to address these significant unmet medical needs by developing combined therapies targeting multiple pathways associated with these diseases, with a primary focus on ALS.

This strategic collaboration with PhaseV is expected to enhance the likelihood of success for NeuroSense's Phase 3 trial of PrimeC, potentially offering new hope for ALS patients.

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