NeuroSense moving to request early approval of PrimeC in Canada
Application draws on benefits seen with combination therapy in Phase 2b trial
NeuroSense Therapeutics has initiated the process of applying to Canada’s regulators for early marketing approval of PrimeC in treating amyotrophic lateral sclerosis (ALS), based on positive findings in a Phase 2b clinical trial.
The application will be filed under Health Canada’s Notice of Compliance with Conditions policy, which could allow NeuroSense to market PrimeC based on incomplete evidence, with the condition that the company undertakes additional studies to verify its clinical benefit.
This approval pathway is available for medications with the potential to treat or prevent serious or life-threatening diseases if they offer a significant improvement over current treatments or if no alternative treatment exists in Canada.
“We are excited to take this important step toward bringing PrimeC to ALS patients in Canada,” Alon Ben-Noon, NeuroSense’s CEO, said in a company press release. “Our goal is to expedite access to this promising therapy, and we are committed to advancing regulatory approvals in Canada and beyond.”
PrimeC combines an antibiotic and an anti-inflammatory in a fixed dose
PrimeC is a fixed-dose combination of the antibiotic ciprofloxacin and the anti-inflammatory celecoxib, both of which are approved for use in multiple indications. PrimeC is designed to target multiple mechanisms involved in ALS, such as inflammation, iron accumulation, and RNA processing.
The move toward early marketing approval builds on results from the Phase 2b PARADIGM trial (NCT05357950) that tested PrimeC against a placebo in 68 adults with ALS. Participants were given two tablets twice daily for six months, and most (96%) then continued or began with the treatment in its open-label extension study.
Most of those enrolled also continued using riluzole, a standard ALS treatment (marketed under the brand names Rilutek, Tiglutik, and Exservan), NeuroSense reported.
Top-line data from the main trial showed that PrimeC treatment for six months tended to slow disease progression, as assessed by the ALS Functional Rating Scale-Revised (ALSFRS-R), and reduced lung function decline compared with a placebo.
These main trial differences failed to reach statistical significance, but data covering PARADIGM and its extension show that PrimeC could significantly slow disease progression. More specifically, patients who started on the experimental therapy in the main trial had a 36% slower progression after one year than those who started it six months later in the extension.
Patients with year of treatment showed 20% slower decline in lung function
Survival in this group also improved by 43% compared with patients initially assigned to the placebo. Likewise, those who received the full year of treatment lived 57% longer without a complication such as respiratory failure or hospitalization, and showed a 20% slower decline in lung function.
Notably, PrimeC’s benefits were particularly pronounced in the trial’s per protocol population, meaning those participants who adhered well to the trial’s established protocol with no major violations or deviations of its rules. In this group, the investigational therapy significantly slowed disease progression by 40% after one year, and survival was extended by 63%.
To date, all patients who completed the full 18 months of PARADIGM requested to continue treatment with PrimeC, being provided to them in an investigator-initiated study. These results “give us confidence that PrimeC can address the urgent unmet needs in ALS treatment,” Ben-Noon said.
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