Neurosense to seek PrimeC approval in Canada next year
Development plans align with Health Canada expectations
- Neurosense will seek Health Canada approval for ALS tretment PrimeC by mid-2026.
- PrimeC aims to reduce inflammation and slow ALS progression.
- A Phase 2b trial showed PrimeC slowed ALS progression by 29.2%; a Phase 3 trial is planned.
Neurosense Therapeutics is gearing up to submit an application to Health Canada for approval of PrimeC to treat amyotrophic lateral sclerosis (ALS).
The company said it had a “productive discussion” with Health Canada, during which the agency confirmed that Neurosense’s proposed next steps align with its expectations. A pre-new drug submission meeting is scheduled for April, with the goal of filing an application for approval by mid-2006.
“This positive engagement reinforces our confidence in the regulatory pathway in Canada,” Alon Ben-Noon, CEO of Neurosense, said in a company press release. “We appreciate the constructive dialogue with Health Canada as we work to bring PrimeC to people living with ALS.”
ALS is characterized by the degeneration and death of motor neurons, the nerve cells that control movement, resulting in muscle weakness that progressively interferes with daily life.
PrimeC is an extended-release tablet containing a patented combination of two medicines — the antibiotic ciprofloxacin and the anti-inflammatory celecoxib — that are approved for other indications. The therapy aims to reduce inflammation and modulate other biochemical mechanisms thought to drive ALS.
Trial shows sustained benefits
PrimeC was tested in the Phase 2b PARADIGM trial (NCT05357950), in which 68 adults with ALS were randomly assigned to receive PrimeC or a placebo twice daily for six months. This was followed by a year-long, open-label extension in which all participants received PrimeC.
Results from the placebo-controlled portion showed that patients given PrimeC had a 29.2% slower progression on a measure of disease severity called the ALS Functional Rating Scale-Revised (ALSFRS-R).
Those benefits were sustained in the long term, with PrimeC slowing disease progression by 32.8% over 18 months in patients who started the medication in the placebo-controlled part. The data also indicated that those who started PrimeC earlier had a 58% higher survival rate.
Based on the Phase 2 trial results, Health Canada said it would consider expedited conditional approval of PrimeC through its Notice of Compliance with Conditions pathway. The agency has since outlined additional requirements, and the company has generated more data and is conducting further analyses to meet those requests.
Meanwhile, Neurosense is preparing to launch a pivotal Phase 3 trial, called PARAGON, to further test PrimeC. The study is expected to enroll about 300 ALS patients in the U.S. and the European Union, with enrollment planned to begin in the coming months.
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