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NeuroSense Secures Key FDA Meeting to Advance its Phase 3 ALS Trial and NDA Submission

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NeuroSense Therapeutics (NASDAQ: NRSN) has secured a Type C meeting with the FDA on November 6, 2024, to discuss the design of its Phase 3 clinical trial for PrimeC, a potential ALS treatment. The meeting will focus on finalizing trial design and reviewing NDA submission readiness.

PrimeC has demonstrated significant results in reducing disease progression markers. The company plans to submit its regulatory dossier to Health Canada in Q2 2025, with a decision expected by Q1 2026. The potential Canadian market opportunity is estimated at $100-150 million in annual revenue. Clinical findings showed PrimeC reduced disease progression (p=0.009) and improved survival rates by 43% compared to placebo.

NeuroSense Therapeutics (NASDAQ: NRSN) ha ottenuto un incontro di tipo C con la FDA il 6 novembre 2024, per discutere la progettazione del suo trial clinico di fase 3 per PrimeC, un potenziale trattamento per la SLA. L'incontro si concentrerà sulla definizione finale del disegno dello studio e sulla revisione della prontezza per la presentazione della NDA.

PrimeC ha dimostrato risultati significativi nella riduzione dei marcatori di progressione della malattia. L'azienda prevede di presentare il suo dossier regolatorio a Health Canada nel secondo trimestre del 2025, con una decisione attesa entro il primo trimestre del 2026. L'opportunità di mercato potenziale in Canada è stimata tra i 100 e i 150 milioni di dollari di ricavi annuali. I risultati clinici hanno mostrato che PrimeC ha ridotto la progressione della malattia (p=0.009) e migliorato i tassi di sopravvivenza del 43% rispetto al placebo.

NeuroSense Therapeutics (NASDAQ: NRSN) ha asegurado una reunión de tipo C con la FDA el 6 de noviembre de 2024 para discutir el diseño de su ensayo clínico de fase 3 para PrimeC, un tratamiento potencial para la ELA. La reunión se centrará en finalizar el diseño del ensayo y revisar la preparación para la presentación de la NDA.

PrimeC ha demostrado resultados significativos en la reducción de los marcadores de progresión de la enfermedad. La empresa planea presentar su expediente regulatorio a Health Canada en el segundo trimestre de 2025, con una decisión esperada para el primer trimestre de 2026. La oportunidad potencial en el mercado canadiense se estima entre 100 y 150 millones de dólares en ingresos anuales. Los hallazgos clínicos mostraron que PrimeC redujo la progresión de la enfermedad (p=0.009) y mejoró las tasas de supervivencia en un 43% en comparación con el placebo.

NeuroSense Therapeutics (NASDAQ: NRSN)은 2024년 11월 6일 FDA와의 타입 C 회의를 통해 PrimeC의 3상 임상 시험 설계를 논의할 예정입니다. 이 회의에서는 시험 설계 최종화 및 NDA 제출 준비 상황 검토에 중점을 둘 것입니다.

PrimeC는 질병 진행 지표 감소에서 상당한 결과를 보여주었습니다. 이 회사는 2025년 2분기에 Health Canada에 규제 문서를 제출할 계획이며, 2026년 1분기까지 결정이 예상됩니다. 캐나다의 잠재적 시장 기회는 연간 1억에서 1억 5천만 달러의 수익으로 추정됩니다. 임상 결과는 PrimeC가 질병 진행(상관계수=0.009)을 줄이고 위약 대비 생존율을 43% 향상시켰음을 보여주었습니다.

NeuroSense Therapeutics (NASDAQ: NRSN) a obtenu une réunion de type C avec la FDA le 6 novembre 2024 pour discuter de la conception de son essai clinique de phase 3 pour PrimeC, un traitement potentiel de la SLA. La réunion portera sur la finalisation de la conception de l'essai et l'examen de la préparation à la soumission de la NDA.

PrimeC a démontré des résultats significatifs dans la réduction des marqueurs de progression de la maladie. L'entreprise prévoit de soumettre son dossier réglementaire à Health Canada au deuxième trimestre de 2025, et une décision est attendue pour le premier trimestre de 2026. L'opportunité de marché potentielle au Canada est estimée entre 100 et 150 millions de dollars de revenus annuels. Les résultats cliniques ont montré que PrimeC a réduit la progression de la maladie (p=0.009) et amélioré les taux de survie de 43 % par rapport au placebo.

NeuroSense Therapeutics (NASDAQ: NRSN) hat ein Type-C-Meeting mit der FDA am 6. November 2024 gesichert, um das Design seiner Phase-3-Studie für PrimeC, eine potenzielle ALS-Behandlung, zu besprechen. Das Meeting wird sich darauf konzentrieren, das Studiendesign abzuschließen und die Bereitschaft zur NDA-Einreichung zu überprüfen.

PrimeC hat signifikante Ergebnisse bei der Reduzierung von Krankheitsschüben gezeigt. Das Unternehmen plant, sein regulatives Dossier im 2. Quartal 2025 bei Health Canada einzureichen, mit einer Entscheidung, die im 1. Quartal 2026 erwartet wird. Die potenzielle Marktchance in Kanada wird auf 100 bis 150 Millionen US-Dollar an jährlichen Einnahmen geschätzt. Klinische Ergebnisse zeigten, dass PrimeC die Krankheitsprogression (p=0.009) um 43 % im Vergleich zu Placebo reduzierte und die Überlebensraten verbesserte.

Positive
  • Secured FDA Type C meeting to advance Phase 3 trial design
  • PrimeC showed 43% improvement in survival rates vs placebo
  • Statistically significant reduction in disease progression (p=0.009)
  • Potential Canadian market opportunity of $100-150M annually
Negative
  • None.

Insights

The upcoming FDA Type C meeting represents a significant milestone in PrimeC's development pathway. The statistically significant reduction in disease progression (p=0.009) and 43% improvement in survival rates from clinical trials are particularly noteworthy metrics for ALS therapeutics. The Canadian market projection of $100-150 million in annual revenue appears conservative given the high unmet need and treatment options for ALS.

However, investors should note that while Type C meetings are important for aligning with regulatory requirements, they are consultative in nature. The timeline to potential commercialization in Canada by Q1 2026 provides a concrete benchmark, but FDA approval timelines remain undefined. The micro-cap status of NeuroSense ($25M) relative to the potential market opportunity suggests significant upside potential, but also reflects the inherent risks in late-stage drug development.

This regulatory progress represents a important value inflection point for NRSN. With a market cap of just $25M, successful commercialization in Canada alone could generate revenue of $100-150M annually - a multiple of the current valuation. The scheduled FDA meeting demonstrates regulatory momentum and de-risks the development pathway.

The micro-cap status presents both opportunity and risk - while positive trial data could drive substantial valuation increases, the company likely needs additional funding to reach commercialization. Investors should monitor cash runway and potential dilution risks. The clear timeline for Canadian regulatory submission in Q2 2025 provides a concrete catalyst for valuation reassessment.

  • Meeting discussion to focus on finalizing Phase 3 study design and NDA readiness, ensuring a clear regulatory path for submission based on trial success
  • Parallel preparations in Canada: NeuroSense plans to submit its dossier in Q2 2025, with a regulatory decision on commercialization expected by Q1 2026

CAMBRIDGE, Mass., Oct. 28, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced it is scheduled for a Type C meeting with the U.S. Food and Drug Administration (FDA) to discuss the design of its upcoming Phase 3 clinical trial for PrimeC, a potential treatment for Amyotrophic Lateral Sclerosis (ALS).

NeuroSense Therapeutics Logo

 

The FDA Type C meeting, scheduled for  November 6, 2024, will focus on finalizing the design of the Phase 3 trial, a pivotal step toward securing approval for the drug. NeuroSense will also review its readiness for a future New Drug Application (NDA) submission, ensuring its regulatory strategy aligns with the FDA's requirements. NeuroSense plans to give an update on the results of the meeting following receipt of the meeting minutes which are expected approximately one month after the meeting.

PrimeC, NeuroSense's lead product, has shown promising results in clinical trials, including a statistically significant reduction in disease progression clinical and biological markers. With an urgent unmet need in ALS, NeuroSense is positioning PrimeC as a potential breakthrough therapy.

In parallel, NeuroSense plans to submit its regulatory dossier to Health Canada in Q2 2025, with a regulatory decision anticipated by Q1 2026. The Company estimates the potential market opportunity for PrimeC in Canada alone to be approximately $100 million to $150 million in annual revenue.

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 43% compared to placebo, highlighting its potential as a breakthrough therapy for ALS.

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 U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and EU.

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 Canada, Italy, and Israel. 96% of the trial participants who completed the 6-month double-blind portion of the trial chose to receive treatment with PrimeC through a 12-month open label extension. Furthermore, to date (June 2024) all participants that completed the 18-month trial treatment duration, requested to continue PrimeC, which is provided to them in an Investigator Initiated Trial, not limited with time.

As previously reported, in the 6-month double-blind segment of the trial, the data showed clinically meaningful signs of efficacy with a 29% difference in favor of PrimeC vs placebo in analysis of the intent to treat (ITT) population. In the PP top-line analysis from PARADIGM, a statistically significant slowing of disease progression was observed with a 37.4% (p=0.03) difference in ALSFRS-R in favor of PrimeC vs placebo. Most patients enrolled in both the active and placebo arms of the trial were concurrently treated with Riluzole, the ALS standard of care medication, indicating PrimeC slowed disease progression well beyond the level afforded by the FDA approved ALS drug.

 

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 U.S. Food and Drug Administration and the European Medicines Agency.

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 Canada and securing regulatory approval in global markets. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. These risks include the risk of a delay in submission by the Company of its regulatory dossier, that regulatory approvals for PrimeC will be delayed or not obtained in Canada or elsewhere; that the market opportunity in Canada will not be as currently estimated; unexpected R&D costs or operating expenses, insufficient capital to complete development of PrimeC, a delay in the reporting of additional results from PARADIGM clinical trial, the timing of expected regulatory and business milestones, risks associated with meeting with the FDA and Health Canada to determine the best path forward following the results from PARADIGM clinical trial, including a delay in any such meeting; the potential for PrimeC to safely and effectively target ALS; preclinical and clinical data for PrimeC; the uncertainty regarding outcomes and the timing of current and future clinical trials; timing for reporting data; the development and commercial potential of any product candidates of Neurosense; the ability of NeuroSense to remain listed on Nasdaq; and other risks and uncertainties set forth in NeuroSense's filings with the Securities and Exchange Commission (SEC). You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting NeuroSense is contained under the heading "Risk Factors" in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 4, 2024 and NeuroSense's subsequent filings with the SEC. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense undertakes no duty to update such information except as required under applicable law.

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SOURCE NeuroSense

FAQ

When is NeuroSense's (NRSN) FDA Type C meeting scheduled for PrimeC?

NeuroSense's FDA Type C meeting is scheduled for November 6, 2024, to discuss the Phase 3 clinical trial design for PrimeC.

What are the clinical results of PrimeC from NeuroSense (NRSN)?

PrimeC demonstrated a statistically significant reduction in disease progression (p=0.009) and improved survival rates by 43% compared to placebo.

When does NeuroSense (NRSN) expect Health Canada's regulatory decision for PrimeC?

NeuroSense expects Health Canada's regulatory decision by Q1 2026, following the planned submission of its regulatory dossier in Q2 2025.

What is the estimated market opportunity for PrimeC in Canada?

NeuroSense estimates the potential market opportunity for PrimeC in Canada to be approximately $100-150 million in annual revenue.

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