NeuroSense to file NDS to Health Canada for PrimeC ALS treatment

1 min read | Published on 22 Jul 2026, 08:28 PM |Updated on 22 Jul 2026, 08:28 PM

Reviewed by

Suketu GScanX News Team

Key Highlights

NeuroSense Therapeutics Ltd. is moving forward with a New Drug Submission to Health Canada for its ALS treatment, PrimeC, after a positive Pre-NDS meeting. The submission is backed by Phase 2b PARADIGM data demonstrating a statistically significant survival benefit and biomarker success. The company anticipates filing the NDS in the coming months.

*this image is generated using AI for illustrative purposes only.

NeuroSense Therapeutics Ltd. intends to proceed with filing a New Drug Submission (NDS) to Health Canada for PrimeC, a treatment for amyotrophic lateral sclerosis (ALS). The planned submission follows a constructive Pre-NDS meeting with the Agency, where NeuroSense aligned on the regulatory pathway. The company expects to complete and file the submission in the coming months, supported by additional data from its Phase 2b PARADIGM clinical program.

The Pre-NDS meeting was held after the generation of substantial evidence from the PARADIGM study. NeuroSense presented Health Canada with a comprehensive update to its proposed NDS package. This included the achievement of the study's prespecified primary TDP-43 biomarker endpoint (p=0.0421) and long-term survival data showing a 14.9-month median survival benefit (HR 0.35, p=0.0037).

Key Data from PARADIGM Program

The following table summarizes the key data points presented to Health Canada:

Metric	Value
Primary TDP-43 biomarker endpoint	p=0.0421
Median survival benefit	14.9 months
Hazard Ratio (HR)	0.35
P-value for survival	p=0.0037

The presentation also included external natural history analyses and additional mechanistic and translational data generated since the company's initial regulatory interaction. An expert clinical perspective from a leading Canadian ALS specialist was part of the meeting, alongside supportive analyses that will be included in the planned NDS package.

NeuroSense plans to continue working with Health Canada as it prepares the NDS filing. The company stated it will provide further updates as the submission advances through the regulatory process.

Disclaimer: This article is AI-generated using data from ViewTrade. ScanX is not liable for any inaccuracies.

What is the anticipated timeline for Health Canada's review and potential approval of the PrimeC NDS?

How might the positive Phase 2b results influence NeuroSense's strategy for seeking regulatory approval in other key markets, such as the U.S. or Europe?

What are the potential market impacts for NeuroSense if PrimeC receives approval, particularly in terms of competition with existing ALS treatments?

NeuroSense to discuss PrimeC Phase 3 plans in Roth ALS webinar

1 min read | Published on 25 Jun 2026, 07:59 PM |Updated on 06 Jul 2026, 07:59 PM

Reviewed by

Naman SScanX News Team

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Key Highlights

NeuroSense Therapeutics announced its participation in a July 8, 2026, Roth Capital Partners webinar to discuss PrimeC's Phase 3 PARAGON study and ALS treatment landscape. The company previously reported that PrimeC met its primary endpoint in the Phase 2b PARADIGM study, significantly reducing TDP-43 levels and slowing disease progression.

*this image is generated using AI for illustrative purposes only.

NeuroSense Therapeutics Ltd. is set to participate in a key opinion leader (KOL) webinar titled "A Quest to Outrun Amyotrophic Lateral Sclerosis (ALS)" on July 8, 2026, at 11:00 a.m. Eastern Time. Hosted by Roth Capital Partners, the event will address unmet needs in ALS treatment, clinical trial endpoint design, and the path forward for NeuroSense's lead candidate, PrimeC. The discussion will feature Professor Jeremy Shefner, Chair of Neurology at Barrow Neurological Institute, and Alon Ben-Noon, Chief Executive Officer of NeuroSense, moderated by Boobalan Pachaiyappan, Ph.D., Managing Director at Roth Capital Partners.

The webinar will examine PrimeC's positioning relative to the current standard of care and the objectives of the pivotal Phase 3 PARAGON study. NeuroSense has secured FDA clearance for this global trial, which aims to enroll approximately 300 participants, primarily in the United States. The company is advancing trial preparations and regulatory interactions across multiple jurisdictions, including Canada.

PrimeC Clinical Background

PrimeC is a novel extended-release oral formulation combining ciprofloxacin and celecoxib, designed to target neuroinflammation, oxidative stress, and dysregulated iron metabolism. The Phase 2b PARADIGM study previously demonstrated that PrimeC met its primary efficacy endpoint by achieving a statistically significant reduction in TDP-43 levels compared to placebo. TDP-43 is a pathological hallmark present in more than 97% of ALS cases.

Outcome Metric	Result	Significance
TDP-43 Reduction (Day 180)	Statistically significant reduction vs. placebo	p=0.0421
TDP-43 Reduction (Day 540)	Sustained and deepened reduction	p<0.001
ALSFRS-R Decline (12 months)	Slowing of decline	36.5%, p=0.008
ALSFRS-R Decline (18 months)	Slowing of decline	32.8%, p=0.007
Median Survival Benefit	~15-month benefit	HR 0.35, p=0.004

Long-term follow-up data from the PARADIGM study indicated a statistically significant ~15-month median survival benefit. Additionally, NeuroSense reported positive biomarker findings from its Phase 2 RoAD proof-of-concept study in Alzheimer's disease, showing changes across biomarkers including TDP-43 and alpha-synuclein.

Alon Ben-Noon, Chief Executive Officer of NeuroSense, emphasized that the Phase 2b results provide compelling evidence supporting PrimeC's potential as a disease-modifying therapy. Prof. Merit Cudkowicz, Director of the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital, noted that the TDP-43 findings suggest target engagement of a central pathological process in ALS.

Disclaimer: This article is AI-generated using data from ViewTrade. ScanX is not liable for any inaccuracies.

What are the key milestones investors should watch for during the Phase 3 PARAGON study enrollment process?

How might the positive biomarker findings from the Alzheimer's RoAD study influence future expansion of PrimeC's clinical pipeline?

What regulatory challenges could NeuroSense face as they seek approvals across multiple jurisdictions like Canada?