“Exceptional Result”: NeuroSense Therapeutics Reports New Positive Data from ALS Trial

NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) has reported additional positive efficacy data from its Phase 2b trial evaluating PrimeC, the company’s lead drug candidate for amyotrophic lateral sclerosis (ALS). The company’s share price rose nearly 30% in trading on Thursday.

Alon Ben-Noon, NeuroSense’s CEO, commented, “As we analyze the PARADIGM trial results, we continue to gain a better understanding of PrimeC’s potential to render a significant and meaningful clinical benefit to people living with ALS. Today we are eager to share these new data with the ALS community, as we believe the PP analysis, demonstrating a statistically significant 37.4% difference in ALSFRS-R in patients treated with PrimeC vs. placebo, is an exceptional result. This data, in conjunction with hopefully correlative neurofilament readouts, will create a regulatory opportunity to advance PrimeC’s development in a breakthrough manner toward the market.”

PrimeC’s meaningful effect magnitude, strong safety profile, and unique mechanism of action will be discussed with the FDA and other regulatory agencies in an End of Phase 2 meeting in H1 2024.

Highlights

NeuroSense’s PARADIGM study is a prospective, multinational, randomized, double-blind, placebo-controlled Phase 2b clinical trial. The trial’s primary endpoints include safety and tolerability, and ALS-related biomarkers TDP-43 and Prostaglandin2.

The study demonstrated a statistically significant slowing of disease progression in ALSFRS-R, in patients treated with PrimeC compared to placebo.

ALSFRS-R is a widely used ALS tracking tool accepted by the FDA, that tracks 12 changes in a person’s physical abilities over time including speech, walking, climbing stairs, dressing/hygiene, handwriting, turning in bed, cutting food, salivation, swallowing, and breathing.

NeuroSense’s lead drug candidate, PrimeC, is a novel extended-release oral formulation composed of a unique fixed-dose combination of ciprofloxacin and celecoxib.

PrimeC is designed to synergistically target several key mechanisms of ALS that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired RNA regulation to potentially inhibit the progression of ALS.

The trial met its primary endpoint of safety and tolerability with results comparable to placebo, establishing a solid safety profile for PrimeC.

About NeuroSense

NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer’s disease and Parkinson’s disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense’s strategy is to develop combined therapies targeting multiple pathways associated with these diseases.