NeuroSense Advances Plans for Early Commercialization of Groundbreaking ALS Treatment in Canada, Provides Further Updates
NeuroSense Therapeutics (Nasdaq: NRSN) has provided an update on its plans to file for early commercialization approval for PrimeC, its ALS treatment, under Health Canada's Notice of Compliance with Conditions (NOC/c) policy. The company plans to submit its dossier in Q2 2025, with an expected regulatory decision by Q1 2026.
The submission is based on promising results from the Phase 2b ALS PARADIGM clinical trial, which showed PrimeC significantly reduced disease progression (p=0.009) and improved survival rates by 43% compared to placebo. NeuroSense estimates a potential peak annual revenue of $100M to $150M in Canada, driven by ALS prevalence and unmet treatment demand.
The company aims to expand approval efforts to additional global markets as part of its strategy to make PrimeC accessible worldwide and drive sustainable growth.
NeuroSense Therapeutics (Nasdaq: NRSN) ha fornito un aggiornamento sui suoi piani per chiedere l'approvazione per la commercializzazione anticipata di PrimeC, il suo trattamento per la SLA, secondo la politica di Notifica di Conformità con Condizioni (NOC/c) di Salute Canada. L'azienda prevede di presentare il suo fascicolo nel secondo trimestre del 2025, con una decisione normativa attesa per il primo trimestre del 2026.
La presentazione si basa su risultati promettenti dello studio clinico di Fase 2b ALS PARADIGM, che ha dimostrato che PrimeC ha significativamente ridotto la progressione della malattia (p=0.009) e ha migliorato i tassi di sopravvivenza del 43% rispetto al placebo. NeuroSense stima un potenziale fatturato annuo massimo di 100 milioni a 150 milioni di dollari in Canada, sostenuto dalla prevalenza della SLA e dalla domanda insoddisfatta di trattamenti.
L'azienda mira ad espandere gli sforzi per ottenere approvazioni in ulteriori mercati globali come parte della sua strategia per rendere PrimeC accessibile in tutto il mondo e promuovere una crescita sostenibile.
NeuroSense Therapeutics (Nasdaq: NRSN) ha proporcionado una actualización sobre sus planes para solicitar la aprobación de comercialización anticipada de PrimeC, su tratamiento para la ELA, según la política de Notificación de Cumplimiento con Condiciones (NOC/c) de Salud Canadá. La empresa planea presentar su expediente en el segundo trimestre de 2025, con una decisión regulatoria esperada para el primer trimestre de 2026.
La presentación se basa en resultados prometedores del ensayo clínico de Fase 2b ALS PARADIGM, que mostró que PrimeC redujo significativamente la progresión de la enfermedad (p=0.009) y mejoró las tasas de supervivencia en un 43% en comparación con el placebo. NeuroSense estima un ingreso anual máximo potencial de 100 millones a 150 millones de dólares en Canadá, impulsado por la prevalencia de la ELA y la demanda no satisfecha de tratamientos.
La empresa busca expandir sus esfuerzos de aprobación a otros mercados globales como parte de su estrategia para hacer que PrimeC sea accesible en todo el mundo y promover un crecimiento sostenible.
NeuroSense Therapeutics (Nasdaq: NRSN)는 캐나다 건강부의 조건부 승인 통지(NOC/c) 정책에 따라 ALS 치료제인 PrimeC의 조기 상용화 승인을 신청할 계획에 대한 업데이트를 제공했습니다. 이 회사는 2025년 2분기에 서류를 제출할 계획이며, 2026년 1분기에 규제 결정이 예상됩니다.
제출은 ALS PARADIGM 2b 임상 시험의 유망한 결과에 기초하고 있으며, PrimeC가 질병의 진행을 유의미하게 감소시켰습니다 (p=0.009) 그리고 위약과 비교해 생존율을 43% 개선했습니다. NeuroSense는 캐나다에서 1억 달러에서 1억 5천만 달러의 잠재적 연간 최고 매출을 추정하고 있으며, 이는 ALS 유병률과 충족되지 않은 치료 수요에 기인합니다.
회사는 PrimeC를 전 세계에서 접근 가능하게 하고 지속 가능한 성장을 촉진하기 위한 전략의 일환으로 추가 글로벌 시장으로의 승인 확대를 목표로 하고 있습니다.
NeuroSense Therapeutics (Nasdaq: NRSN) a fourni une mise à jour sur ses projets de demande d'approbation pour la commercialisation anticipée de PrimeC, son traitement de la SLA, conformément à la politique de Notification de Conformité avec Conditions (NOC/c) de Santé Canada. L'entreprise prévoit de soumettre son dossier au 2e trimestre 2025, avec une décision réglementaire attendue d'ici le 1er trimestre 2026.
La soumission repose sur des résultats prometteurs de l'essai clinique de Phase 2b ALS PARADIGM, qui a montré que PrimeC a significativement réduit la progression de la maladie (p=0.009) et a amélioré les taux de survie de 43% par rapport au placebo. NeuroSense estime un chiffre d'affaires annuel maximal potentiel de 100 millions à 150 millions de dollars au Canada, stimulé par la prévalence de la SLA et une demande de traitement non satisfaite.
L'entreprise vise à élargir ses efforts d'approbation à d'autres marchés mondiaux, dans le cadre de sa stratégie visant à rendre PrimeC accessible dans le monde entier et à favoriser une croissance durable.
NeuroSense Therapeutics (Nasdaq: NRSN) hat ein Update zu seinen Plänen gegeben, einen Antrag auf frühzeitige Marktzulassung für PrimeC, seine ALS-Behandlung, gemäß der Richtlinie über die Mitteilung zur Einhaltung von Bedingungen (NOC/c) von Health Canada einzureichen. Das Unternehmen plant, sein Dossier im 2. Quartal 2025 einzureichen, mit einer erwarteten regulatorischen Entscheidung im 1. Quartal 2026.
Die Einreichung basiert auf vielversprechenden Ergebnissen der Phase-2b-ALS-PARADIGM-Studie, die zeigte, dass PrimeC die Krankheitsprogression signifikant reduzierte (p=0.009) und die Überlebensraten um 43% im Vergleich zu Placebo verbesserte. NeuroSense schätzt ein potenzielles maximales Jahresumsatzvolumen von 100 bis 150 Millionen Dollar in Kanada, angetrieben von der Prävalenz von ALS und der nicht gedeckten Nachfrage nach Behandlungen.
Das Unternehmen strebt an, die Genehmigungsbemühungen auf weitere globale Märkte auszudehnen, um PrimeC weltweit zugänglich zu machen und nachhaltiges Wachstum zu fördern.
- PrimeC significantly reduced ALS disease progression (p=0.009) in Phase 2b clinical trial
- PrimeC improved survival rates by 43% compared to placebo
- Estimated potential peak annual revenue of $100M to $150M in Canada
- Plans to expand approval efforts to additional global markets
- Regulatory decision for PrimeC in Canada not expected until Q1 2026
- Revenue projections are estimates and may not materialize
Insights
This news is highly significant for NeuroSense Therapeutics and the ALS treatment landscape. The planned submission for early commercialization of PrimeC in Canada under the NOC/c policy is a major step forward, potentially accelerating market entry for this promising ALS therapy. The Phase 2b results showing significant reduction in disease progression (p=0.009) and a
The estimated peak annual revenue of
However, investors should note that regulatory approval is not guaranteed and the timeline to potential commercialization (Q1 2026) is still relatively distant. The company's ability to execute on its regulatory strategy and successfully commercialize PrimeC will be critical factors to watch in the coming years.
The clinical data for PrimeC is truly remarkable in the context of ALS treatment. A
From a medical perspective, the NOC/c pathway in Canada is designed for promising therapies addressing serious, life-threatening conditions with treatment options - a perfect fit for PrimeC in ALS. This could potentially provide earlier access to a groundbreaking treatment for Canadian ALS patients.
It's important to note that while these results are highly encouraging, they come from a Phase 2b trial. Typically, larger Phase 3 trials are required for full approval. The conditional approval pathway may allow for market entry based on this data, but ongoing studies and post-market surveillance will likely be necessary to confirm the long-term safety and efficacy of PrimeC.
- Dossier submission planned for Q2 2025; regulatory decision expected by Q1 2026
- Estimated potential market opportunity: peak of
$100M $150M - Company aims to expand approval efforts to additional global markets
This decision follows the recommendations of Canadian regulatory experts and recent clinical findings, which demonstrated that PrimeC significantly reduced disease progression (p=0.009) and improved survival rates by
NeuroSense estimates a significant market opportunity in
Alon Ben-Noon, CEO of NeuroSense, stated, "The Canadian market presents a significant near-term opportunity, with the addressable market for PrimeC valued above
About ALS
Amyotrophic lateral sclerosis ("ALS") is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 people are diagnosed with ALS in the
About ALSFRS-R
Disease progression is measured by the ALS Functional Rating Scale-Revised (ALSFRS-R), which is the most widely used ALS tracking tool accepted by the FDA, utilized by neurologists treating ALS patients, in clinical trials, and by other regulators to determine disease progression. It tracks 12 changes in a person's physical abilities over time including functions such as: speech, walking, climbing stairs, dressing/hygiene, handwriting, turning in bed, cutting food, salivation, swallowing, and breathing. A single point change on the ALSFRS-R has a significant impact on ALS patients, such as the transition from independent feeding to requiring assistance or independent breathing to needing to use a machine ventilator.
About PARADIGM
PARADIGM is a prospective, multinational, randomized, double-blind, placebo-controlled Phase 2b (NCT05357950) clinical trial of PrimeC in ALS. The trial included 68 participants living with ALS in
As previously reported, in the 6-month double-blind segment of the trial, the data showed clinically meaningful signs of efficacy with a
About PrimeC
PrimeC, NeuroSense's lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several key mechanisms of ALS that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid ("RNA") regulation to potentially inhibit the progression of ALS. NeuroSense completed a Phase 2a clinical trial which met its safety and efficacy endpoints including reducing functional and respiratory deterioration and statistically significant changes in ALS-related biological markers indicating PrimeC's biological activity. PrimeC was granted Orphan Drug Designation by the
About NeuroSense
NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer's disease and Parkinson's disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense's strategy is to develop combined therapies targeting multiple pathways associated with these diseases.
For additional information, we invite you to visit our website and follow us on LinkedIn, YouTube and X. Information that may be important to investors may be routinely posted on our website and these social media channels.
Forward-Looking Statements
This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics' current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding the timing of regulatory filings and regulatory decisions, the market opportunity in
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SOURCE NeuroSense
FAQ
When does NeuroSense plan to submit the dossier for PrimeC to Health Canada?
What were the key results from the Phase 2b ALS PARADIGM clinical trial for PrimeC?
What is the estimated market opportunity for PrimeC in Canada according to NRSN?
When does NeuroSense expect a regulatory decision for PrimeC from Health Canada?
