Neurosense, awaiting Canada approval, scales PrimeC production
Company bolsters supply chain ahead of potential OK
Neurosense Therapeutics said it’s scaled production of PrimeC, its oral therapy for amyotrophic lateral sclerosis (ALS), to commercial levels as it awaits regulatory approval to launch the medication in Canada.
“This manufacturing milestone represents a critical leap forward in our commercialization roadmap,” Alon Ben-Noon, CEO of Neurosense, said in a company press release.
Based on results from the Phase 2b PARADIGM trial (NCT05357950), the country’s regulatory agency said it would consider expedited conditional approval of PrimeC through its Notice of Compliance with Conditions pathway. This process is intended to increase access to promising treatments for conditions with unmet therapeutic needs. The company has also said it plans a Phase 3 clinical trial of the therapy.
ALS is caused by the death of neurons that control voluntary muscle movement. This leads to ALS symptoms including muscle weakness and difficulty moving.
PrimeC targets inflammation and other processes that drive symptom development in ALS. The therapy is a patented combination of ciprofloxacin, an antibiotic, and celecoxib, an anti-inflammatory medication. Both active ingredients are approved for multiple indications in the U.S. and Canada.
‘Resilient supply chain’
Neurosense said it has “established a resilient supply chain” by qualifying U.S. and Canadian Drug Master File and Certificate of Suitability holders for both active ingredients to “enable dependable and compliant sourcing for commercial-scale production volumes.” It also said it’s partnering with a global contract development and manufacturing organization to support supply of the treatment.
“With commercial-scale production validated and a 36-month room-temperature shelf life confirmed, PrimeC is now positioned to rapidly enter the Canadian market upon regulatory approval,” Ben-Noon said.
Preliminary results from the PARADIGM trial indicated that PrimeC may slow disease progression and increase survival rates in ALS. Participants were randomly assigned to receive either the treatment or a placebo for the first six months of the study. As part of the open-label extension study, all participants were then eligible to receive PrimeC therapy for up to a year.
Participants who received the full 18 months of treatment had 32.8% slower disease progression than those who started the therapy at the six-month mark. The former group also had a 58% increase in survival rate, although this did not achieve statistical significance.
Data have shown PrimeC reduces blood levels of microRNAs, a type of molecule that helps regulate genes, related to ALS progression and survival.
Neurosense said early entry into the Canadian market “would not only address an urgent medical need but also provide valuable real-world data” along with a “strategic foundation for global expansion.”
The company said it will be able to rapidly roll out commercialization if conditional approval is granted.
”This achievement, coupled with our patent protection through 2042, strengthens our ability to deliver PrimeC to ALS patients who urgently need new therapeutic options,” Ben-Noon said.
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