NeuroSense Unveils Accelerated, Capital-Efficient PrimeC Development Strategy In ALS
(RTTNews) - NeuroSense Therapeutics Ltd. (NRSN), on Monday announced a redesigned development strategy for PrimeC in amyotrophic lateral sclerosis (ALS), aimed at accelerating the potential path toward regulatory submission and approval while reducing overall development costs.
The new strategy comprises three focused initiatives: AI-enabled characterization of PrimeC's formulation advantage, a direct comparative study against edaravone, and an optimized pivotal development pathway.
PrimeC Development Strategy
NeuroSense plans to use AI-enabled modeling of clinical pharmacokinetic data to further characterize PrimeC's extended-release formulation, which is designed to synchronize the exposure profiles of its two active components.
The analysis is intended to quantify the formulation's potential advantages and support additional intellectual property protection.
The company also plans to conduct an active-comparator study evaluating PrimeC directly against edaravone, an established ALS therapy.
NeuroSense said the head-to-head study could provide data on PrimeC's relative clinical value and commercial potential.
Phase 3 PARAGON NeuroSense is evaluating an optimized design for its Phase 3 PARAGON trial that would be substantially smaller and shorter than previously planned and would focus on patients earlier in the course of ALS.
The company has received FDA clearance to initiate PARAGON and plans to discuss with the FDA whether existing data could support a full approval pathway or an Accelerated Approval pathway, with any required post-approval study.
Canada Regulatory Pathway
NeuroSense has completed the pre-New Drug Submission process with Health Canada and is preparing a New Drug Submission for PrimeC, which it continues to target for December 2026.
If accepted and approved, the Canadian regulatory pathway could potentially provide earlier access to PrimeC for patients.
The redesigned strategy builds on data from the Phase 2b PARADIGM study, which showed clinically meaningful effects on functional decline, significant modulation of extracellular vesicle-associated TDP-43, consistent changes across multiple disease-related biomarkers and encouraging long-term survival results.
About PrimeC
PrimeC is an investigational extended-release oral therapy combining ciprofloxacin and celecoxib in a fixed-dose formulation.
The treatment is designed to target multiple biological pathways implicated in ALS, including neuroinflammation, oxidative stress, iron accumulation and dysregulated RNA regulation.
NRSN has traded between $0.25 and $1.98 over the last year. The stock closed Wednesday's trade at $0.41, down 2.21%. In the pre-market, NRSN is down 3.09% at $0.42.
