NeuroSense to discuss PrimeC Phase 3 plans in Roth ALS webinar

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Reviewed by
Naman SScanX News Team
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.

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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?

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NeuroSense Therapeutics secures Japanese patent for PrimeC ALS treatment

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Reviewed by
Shriram SScanX News Team
Key Highlights

NeuroSense Therapeutics Ltd. has been granted Japanese Patent 7857044 for its ALS drug candidate PrimeC, providing protection through 2042. The patent covers the formulation and synchronized delivery of ciprofloxacin and celecoxib. This follows prior patents in the U.S., Australia, and Brazil, bolstering NeuroSense's global IP portfolio.

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NeuroSense Therapeutics Ltd. has secured Japanese Patent 7857044 from the Japan Patent Office, covering its lead drug candidate PrimeC for the treatment of amyotrophic lateral sclerosis (ALS). The patent protection extends through 2042, strengthening the company's intellectual property portfolio following recent grants in the U.S., Australia, and Brazil. This development is significant for NeuroSense as it reinforces the proprietary position of its late-clinical stage treatment targeting severe neurodegenerative diseases.

The patent, titled "Compositions comprising ciprofloxacin and celecoxib," includes 17 claims. It safeguards the unique formulation and manufacturing process of PrimeC, specifically its synchronized delivery profile of celecoxib and ciprofloxacin. This mechanism is designed to target multiple key pathways underlying ALS progression, offering a novel approach to managing the disease.

Patent Details

The issuance of Japanese Patent 7857044 marks a milestone in NeuroSense's global intellectual property strategy. The patent's claims cover the specific combination and delivery method of the two active ingredients, which are central to PrimeC's therapeutic potential. By securing protection until 2042, NeuroSense aims to maintain a competitive edge in the ALS treatment landscape.

Aspect Detail
Patent Number 7857044
Jurisdiction Japan
Protection Period Through 2042
Claims 17
Key Components Ciprofloxacin and celecoxib
Primary Focus Unique formulation and synchronized delivery profile for ALS treatment

NeuroSense's PrimeC is currently in late-clinical stages, focusing on addressing the complex mechanisms of ALS. The recent patent approvals in multiple jurisdictions underscore the drug's innovative approach and the company's commitment to advancing treatments for neurodegenerative conditions.

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

How will the Japanese patent protection influence potential partnerships or licensing agreements with local pharmaceutical companies?

What are the next regulatory milestones for PrimeC following the completion of its late-clinical stages?

How does the secured patent portfolio impact NeuroSense's ability to attract further investment for ALS research?

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