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By Kyle Anthony, Benzinga
NeuroSense Therapeutics Ltd. (NASDAQ: NRSN), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases – such as amyotrophic lateral sclerosis (ALS), Alzheimer's disease and Parkinson's disease – recently announced its plans to file for early commercialization approval for PrimeC, the firm’s leading drug candidate designed to synergistically target several biological mechanisms of ALS, under Health Canada’s Notice of Compliance with Conditions (NOC/c) policy. This submission is backed by promising results from the company’s phase 2b ALS PARADIGM clinical trial and supplementary clinical and preclinical data.
ALS Explained
ALS is a nervous system disease that affects nerve cells in the brain and spinal cord. The disease causes loss of muscle control, and gradually worsens over time. Often called Lou Gehrig's disease after the baseball player who was diagnosed with it, the exact cause of the disease is still not known.
ALS often begins with muscle twitching and weakness in the arm or leg, trouble swallowing or slurred speech. Eventually, ALS affects the control of the muscles needed to move, speak, eat and breathe. There is no cure for this fatal disease. Every year, more than 5,000 people are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and European Union.
The Efficacy Of NeuroSense’s PrimeC Treatment
PrimeC, NeuroSense's lead drug candidate, is a novel extended-release oral formulation with a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several biological mechanisms of ALS that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid (RNA) regulation. The goal is to inhibit the progression of ALS.
NeuroSense reports that PARADIGM, a prospective, multinational, randomized, double-blind, placebo-controlled phase 2b clinical trial of PrimeC in ALS, has demonstrated the drug's efficacy. The trial demonstrated that PrimeC significantly reduced disease progression (p=0.009) and improved survival rates by 43% compared to placebo, highlighting its potential as a breakthrough therapy for ALS.
The trial included 68 participants living with ALS in Canada, Italy and Israel. 96% of the trial participants who completed the 6-month double-blind portion of the trial chose to receive treatment with PrimeC through a 12-month open-label extension. As of June 2024, all participants who completed the 18-month trial treatment duration requested to continue PrimeC, which is provided to them in an Investigator Initiated Trial, not limited to time.
The PARADIGM clinical study observed a statistically significant slowing of disease progression in patients who used PrimeC versus placebo, based on the ALS Functional Rating Scale-Revised (ALSFRS-R). The Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) is the gold standard instrument for evaluating the functional status of patients with ALS. It is used to monitor functional change in a patient over time.
NeuroSense reports that most patients enrolled in both the active and placebo arms of the trial were concurrently treated with Riluzole, the ALS standard of care medication, indicating PrimeC slowed disease progression well beyond the level afforded by the FDA-approved ALS drug. The FDA and the European Medicines Agency have granted PrimeC Orphan Drug Designation.
Commercialization Of PrimeC In Canada And Worldwide
Health Canada’s Notice of Compliance with Conditions (NOC/c) is authorization to market a drug, with the condition that the sponsor undertake additional studies to verify the clinical benefit. As such, this speeds up the time to market for the drug, enabling earlier commercialization.
In advancing PrimeC's commercialization potential, NeuroSense plans to submit its regulatory dossier to Health Canada in Q2 2025, with a regulatory decision anticipated by Q1 2026, and NeuroSense estimates the market opportunity for PrimeC in Canada alone to be approximately $100 million to $150 million in annual revenue, reflecting the unmet need for effective ALS treatments. Beyond Canada, NeuroSense plans to pursue regulatory approval in additional global markets as part of its broader strategy to make PrimeC accessible to ALS patients worldwide.
Alon Ben-Noon, CEO of NeuroSense, stated, “The Canadian market presents a significant near-term opportunity, with the addressable market for PrimeC valued above $100 million in annual revenue. Securing early commercialization approval in Canada would represent an important milestone, not only to address the unmet need for ALS treatments but also as part of our strategy to drive sustainable growth. With additional markets on our radar, this marks the beginning of what we anticipate will be a long-term revenue-generating opportunity."
Looking Forward
NeuroSense’s PrimeC has the potential to reshape the landscape for ALS treatment, enhancing the quality of life for individuals around the globe afflicted by this debilitating disease. The promising results from the PARADIGM clinical trial and NeuroSense's commercial advancement plans for the drug indicate that PrimeC may soon be able to benefit ALS patients around the world and potentially position the company to be a leader in treating the disease.
Featured photo courtesy of NeuroSense Therapeutics.
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