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.
Comments