NeuroSense Therapeutics Ltd., 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.
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00:00Neurosense Therapeutics Limited, NASDAQ, NRSN, a late-stage biotech firm, is advancing its
00:09lead drug candidate, Prime-C, designed to treat amyotrophic lateral sclerosis, ALS.
00:16The company plans to seek early commercialization approval for Prime-C under Health Canada's
00:21Notice of Compliance with Conditions policy, supported by positive Phase 2b clinical trial
00:26results from its ALS paradigm study.
00:29ALS, often called Lou Gehrig's disease, is a neurodegenerative condition that progressively
00:35impairs muscle control, ultimately affecting movement, speech, and breathing.
00:40Currently, there is no cure, and more than 5,000 new cases are diagnosed annually in
00:45the U.S. alone, with the disease burden expected to rise by 24% by 2040.
00:52Prime-C is a novel oral formulation combining Cyprofloxacin and Celecoxib, two FDA-approved
00:58drugs, aimed at slowing ALS progression by targeting motor neuron degeneration, inflammation,
01:05iron buildup, and RNA regulation.
01:08The paradigm trial demonstrated that Prime-C significantly slowed disease progression and
01:13improved survival rates by 43% compared to placebo.
01:17ALS participants chose to continue the drug after the trial's conclusion.
01:22Neurosense plans to submit Prime-C's regulatory dossier to Health Canada in Q2 2025, with
01:29a decision expected by Q1 2026.
01:32The Canadian market presents a potential $100 to $150 million annual revenue opportunity.
01:39Beyond Canada, the company aims to secure global approvals, positioning Prime-C as a
01:44key treatment for ALS worldwide.
01:47CEO Alon Ben-Noon highlighted Canada as a strategic market, marking the beginning of
01:53a long-term growth trajectory for Neurosense.
01:57Prime-C's promising trial results and commercialization efforts could offer new hope for ALS patients
02:02globally, reinforcing Neurosense's role in addressing this unmet medical need.