Health Canada set to consider giving early approval to PrimeC for ALS
Neurosense reports meeting requested as plans for Phase 3 trial continue
Health Canada has invited Neurosense Therapeutics to discuss the potential for giving conditional approval to PrimeC in treating amyotrophic lateral sclerosis (ALS), according to a company filing with the U.S. Securities and Exchange Commission.
The upcoming meeting provides an opportunity to consider if the drug is eligible for Health Canada’s Notice of Compliance with Conditions pathway, which applies to medications expected to offer a significant improvement over those currently available to treat or prevent serious or life-threatening diseases, or in cases where no alternatives exist in the market.
A positive finding could allow PrimeC to be marketed in Canada — possibly starting in the first half of 2026 — based on promising early evidence of its effectiveness in ALS, according to a press release. Under the pathway’s terms, Neurosense must undertake additional studies to verify PrimeC’s clinical benefit.
Plans are advancing for a pivotal Phase 3 trial of PrimeC that the company hopes to initiate by mid-2025. Those plans were announced earlier and repeated in the recent release.
Slower disease progression seen in ALS patients with year of treatment
PrimeC is an extended-release tablet that combines at fixed dose the antibiotic ciprofloxacin and the anti-inflammatory drug celecoxib, two medications approved for use in other indications. PrimeC is designed to target inflammation and other mechanisms that drive the symptoms of ALS.
The move toward conditional approval draws on positive data from the PARADIGM Phase 2b clinical trial (NCT05357950) and its extension study. PrimeC was tested in the main trial against a placebo, both taken as two tablets twice daily for six months, in 68 adults with ALS. Most patients moved into the open-label extension, where all were treated with PrimeC.
A trend toward slower disease progression, as assessed by the ALS Functional Rating Scale-Revised (ALSFRS-R), and slower lung function decline was seen in treated patients in the main trial compared with those on a placebo. Extension study data then showed a significant slowing of disease progression — by 36% — among patients using PrimeC for a full year, compared with those given a placebo for six months before transitioning to the treatment. Survival rates also improved by 43%.
Planned Phase 3 trial could support full approval in Canada, elsewhere
Benefits were even more pronounced in a patient group that strictly adhered to the trial’s established protocol, called the per protocol population. Among adults in this group who started on PrimeC in the main trial, declines in ALSFRS-R scores slowed by 40% and survival improved by 63% at a full year of treatment.
The planned Phase 3 clinical trial of PrimeC could serve as a confirmatory study for full approval should Health Canada agree to conditionally approve the treatment. Positive findings also are expected to support an approval application to the U.S. Food and Drug Administration, and to health authorities in other global markets.
The company estimates that PrimeC will have a peak annual revenue of $100 million to $150 million in the Canadian market.
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