NeuroSense R&D VP Shiran Zimri to Join 3rd Annual ALS Drug Summit

In CAMBRIDGE, Mass., on May 20, 2024, NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) announced that its Vice President of R&D, Dr. Shiran Zimri, will be a key presenter at the ALS Drug Development Summit in Boston, Mass., on May 22, 2024. NeuroSense is a company committed to developing innovative treatments for severe neurodegenerative diseases.

Dr. Zimri is scheduled to present in a session titled "Exploring the Potentials of Combination Therapy in ALS & Showcasing Latest Progress of PrimeC." She will provide an update on the latest findings from NeuroSense's Phase 2b clinical trial, PARADIGM. Additionally, Dr. Zimri will lead and moderate a workshop at the pre-conference event, focusing on combination therapy as a novel approach for treating ALS (Amyotrophic Lateral Sclerosis).

Expressing her enthusiasm, Dr. Zimri stated, "I am thrilled to participate in and speak at this conference. I eagerly anticipate sharing our findings and plans, engaging with participants, and exploring new opportunities. The positive reception from the scientific community regarding the PARADIGM outcomes has been gratifying. We are eager to advance PrimeC to the next stage and share our plans with regulators."

Recently, NeuroSense announced additional results from the PARADIGM trial, highlighting a statistically significant 43% slowing of disease progression in high-risk ALS patients treated with PrimeC compared to placebo after six months. This translates to a 5.04-point difference in ALSFRS-R scores favoring PrimeC in the per protocol population analysis.

ALS, a debilitating neurodegenerative disease, leads to complete paralysis and death within 2-5 years from diagnosis. Annually, over 5,000 patients are diagnosed with ALS in the U.S., contributing to an annual disease burden of $1 billion. The number of ALS patients is expected to grow by 24% by 2040 in the U.S. and EU.

The ALS Functional Rating Scale-Revised (ALSFRS-R) is the most widely used tool for tracking ALS progression. It measures changes in physical abilities over time, including speech, walking, and breathing. A single-point change on the ALSFRS-R significantly impacts ALS patients' lives, such as transitioning from independent feeding to requiring assistance.

PARADIGM is a prospective, multinational, randomized, double-blind, placebo-controlled Phase 2b clinical trial of PrimeC, NeuroSense's lead drug candidate. The trial included 68 participants from Canada, Italy, and Israel. 96% of participants who completed the six-month double-blind portion opted to receive PrimeC through a 12-month open label extension. All participants who completed the 18-month treatment duration requested to continue PrimeC in an Investigator Initiated Trial.

Top-line data from the six-month double-blind segment showed a 29% difference in ALSFRS-R and a 13% difference in SVC favoring PrimeC vs. placebo in the intent-to-treat population. The per protocol analysis revealed a statistically significant 37.4% slowing of disease progression favoring PrimeC. Most patients in the trial were concurrently treated with Riluzole, the ALS standard of care medication.

PrimeC, NeuroSense's lead drug candidate, is a novel extended-release oral formulation combining ciprofloxacin and celecoxib. It targets key mechanisms of ALS, including motor neuron degeneration, inflammation, iron accumulation, and impaired RNA regulation. NeuroSense completed a Phase 2a clinical trial that met its safety and efficacy endpoints, including reducing functional and respiratory deterioration and significant changes in ALS-related biological markers. PrimeC has been granted Orphan Drug Designation by both the U.S. Food and Drug Administration and the European Medicines Agency.

NeuroSense Therapeutics Ltd. is a clinical-stage biotechnology company focused on developing treatments for debilitating neurodegenerative diseases, including ALS, Alzheimer's disease, and Parkinson's disease. The company aims to develop combined therapies targeting multiple pathways associated with these diseases.