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Eventos de NRSN
NeuroSense Unveils Redesigned Development Plan for PrimeC
NeuroSense Therapeutics announced a redesigned development plan for PrimeC in amyotrophic lateral sclerosis, structured to reach a potential path for regulatory submission and approval faster and at materially lower cost than the Company's previously planned development path. "One of the hardest constraints in ALS is not scientific - it is that the standard development path takes longer than patients have," said Alon Ben-Noon, Co-Founder and Chief Executive Officer of NeuroSense. "We have asked a straightforward question: what is the shortest reasonable route from the data we already hold to a therapy people can actually receive? This plan is our answer. It is faster, it costs less, and it produces a stronger package - pharmacology, comparative clinical context, and a pivotal dataset - than the single-trial approach would have."
NeuroSense Targets December 2026 for New Drug Submission
NeuroSense Therapeutics announced that it is targeting December 2026 for the filing of a New Drug Submission with Health Canada for PrimeC, its lead therapeutic candidate for amyotrophic lateral sclerosis. The filing target follows the successful finalization of the Pre-NDS process with Health Canada and the associated meeting minutes. The discussions with Health Canada provided alignment regarding the content and structure of the submission. Health Canada has also indicated that it has no concerns with the company's proposed filing timeline and advised the company to target early December.
NeuroSense Files New Drug Submission for PrimeC to Treat ALS
NeuroSense Therapeutics announced it intends to proceed with the filing of a New Drug Submission, or NDS, to Health Canada for PrimeC for the treatment of amyotrophic lateral sclerosis, or ALS, following a constructive Pre-New Drug Submission meeting with the Agency. NeuroSense expects to complete and file the submission in the coming months. The recent Pre-NDS meeting was held following the generation of substantial additional evidence from the Phase 2b PARADIGM clinical program. NeuroSense presented Health Canada with a comprehensive update to its proposed NDS package, including achievement of the study's prespecified primary TDP-43 biomarker endpoint, long-term survival, external natural history analyses, and additional mechanistic and translational data generated since the Company's initial regulatory interaction. The meeting also included an expert clinical perspective from a leading Canadian ALS specialist, as well as additional supportive analyses that will form part of the planned NDS package, further strengthening the growing body of evidence supporting PrimeC's potential in ALS. NeuroSense plans to continue to work with Health Canada as it prepares the NDS filing, and looks forward to providing further updates as the submission advances.
NeuroSense's PrimeC ALS Study Successfully Meets Primary Efficacy Endpoint
NeuroSense Therapeutics announced that its Phase 2b PARADIGM study of PrimeC in amyotrophic lateral sclerosis has successfully met its primary efficacy endpoint, demonstrating a statistically significant reduction in TDP-43 levels compared to placebo. This is the first randomized, double-blind, placebo-controlled clinical study to demonstrate a treatment-associated reduction in TDP-43 in people living with ALS. The analysis was performed using the NeuroDex ExoSORT procedure, an immunoaffinity-based methodology that selectively isolates neuron-derived extracellular vesicles. This approach enables measurement of neuron-derived TDP-43, providing a CNS-relevant signal that can be distinguished from TDP-43 released by non-neuronal cells and peripheral tissues. TDP-43 is the defining pathological hallmark of ALS, present in more than 97% of cases, and is widely recognized as a central driver of disease progression. The observed reduction in TDP-43 provides biological evidence that PrimeC is engaging a core disease mechanism.
NeuroSense Secures Korean Patent for PrimeC
NeuroSense Therapeutics announced that the Korean Intellectual Property Office has issued Korean Patent Number 10-2969898 covering the composition of PrimeC, the company's lead drug candidate for the treatment of amyotrophic lateral sclerosis. The granted patent claims cover key aspects of PrimeC, including its proprietary tablet formulation, manufacturing process, pharmacokinetic characteristics, and pharmaceutical use for the treatment of ALS. The patent is expected to provide patent protection for such aspects of PrimeC in South Korea through 2042.
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