NeuroSense Receives Positive FDA Feedback on Phase 3 Study Design for PrimeC
NeuroSense Therapeutics (NASDAQ: NRSN) has received positive FDA feedback on their Phase 3 study design for PrimeC, their ALS treatment candidate. Following a Type C meeting with the FDA, the company plans to submit a final protocol in H1 2025 and begin the pivotal Phase 3 study by mid-2025.
The planned Phase 3 study will be randomized, multi-center, multinational, double-blind, and placebo-controlled, involving approximately 300 patients in a 2:1 ratio (PrimeC to placebo). The study will include a 12-month treatment period followed by a 12-month open label extension where all participants will receive PrimeC.
This development follows the completion of their PARADIGM Phase 2b clinical trial, where PrimeC demonstrated significant impact on slowing disease progression and increasing survival rates in ALS patients.
NeuroSense Therapeutics (NASDAQ: NRSN) ha ricevuto un feedback positivo dalla FDA sul design dello studio di Fase 3 per PrimeC, il candidato per il trattamento della SLA. A seguito di un incontro di tipo C con la FDA, l'azienda prevede di presentare un protocollo finale nel primo semestre del 2025 e di avviare lo studio pivotale di Fase 3 entro la metà del 2025.
Lo studio di Fase 3 pianificato sarà randomizzato, multicentrico, multinazionale, in doppio cieco e controllato con placebo, coinvolgendo circa 300 pazienti in un rapporto di 2:1 (PrimeC rispetto al placebo). Lo studio comprenderà un periodo di trattamento di 12 mesi seguito da un'estensione in aperto di 12 mesi in cui tutti i partecipanti riceveranno PrimeC.
Questo sviluppo segue il completamento del loro trial clinico di Fase 2b PARADIGM, nel quale PrimeC ha dimostrato un impatto significativo nel rallentare la progressione della malattia e nell'aumentare i tassi di sopravvivenza nei pazienti con SLA.
NeuroSense Therapeutics (NASDAQ: NRSN) ha recibido comentarios positivos de la FDA sobre el diseño de su estudio de Fase 3 para PrimeC, su candidato a tratamiento para la ELA. Tras una reunión de tipo C con la FDA, la compañía planea presentar un protocolo final en el primer semestre de 2025 y comenzar el estudio pivotal de Fase 3 a mediados de 2025.
El estudio de Fase 3 planeado será aleatorio, multicéntrico, multinacional, doble ciego y controlado con placebo, involucrando aproximadamente a 300 pacientes en una proporción de 2:1 (PrimeC frente a placebo). El estudio incluirá un período de tratamiento de 12 meses seguido de una extensión abierta de 12 meses, donde todos los participantes recibirán PrimeC.
Este desarrollo sigue a la finalización de su ensayo clínico PARADIGM de Fase 2b, donde PrimeC demostró un impacto significativo en la ralentización de la progresión de la enfermedad y el aumento de las tasas de supervivencia en pacientes con ELA.
NeuroSense Therapeutics (NASDAQ: NRSN)는 PrimeC의 ALS 치료 후보에 대한 3상 연구 설계에 대해 FDA로부터 긍정적인 피드백을 받았습니다. FDA와의 Type C 회의 후, 회사는 2025년 상반기에 최종 프로토콜을 제출하고 2025년 중반에 중대한 3상 연구를 시작할 계획입니다.
계획된 3상 연구는 무작위, 다센터, 다국적, 이중 맹검 및 위약 대조 방식으로 진행되며, 약 300명의 환자가 2:1 비율(PrimeC 대 위약)로 참여합니다. 연구는 12개월 치료 기간과 그 후 모든 참가자가 PrimeC를 받을 12개월의 공개 연장으로 구성됩니다.
이 개발은 PrimeC가 ALS 환자의 질병 진행을 늦추고 생존율을 높이는 데 상당한 영향을 미쳤던 PARADIGM 2b 단계의 임상 시험 완료에 이어 진행됩니다.
NeuroSense Therapeutics (NASDAQ: NRSN) a reçu des retours positifs de la FDA concernant le design de son étude de Phase 3 pour PrimeC, son candidat traitement pour la SLA. Suite à une réunion de type C avec la FDA, la société prévoit de soumettre un protocole final au premier semestre 2025 et de commencer l'étude pivot de Phase 3 d'ici la mi-2025.
L'étude de Phase 3 prévue sera randomisée, multicentrique, multinationale, en double aveugle et contrôlée par placebo, impliquant environ 300 patients dans un ratio de 2:1 (PrimeC par rapport à placebo). L'étude comprendra une période de traitement de 12 mois suivie d'une extension en ouvert de 12 mois où tous les participants recevront PrimeC.
Ce développement fait suite à l'achèvement de leur essai clinique PARADIGM de Phase 2b, où PrimeC a démontré un impact significatif sur le ralentissement de la progression de la maladie et l'augmentation des taux de survie chez les patients atteints de SLA.
NeuroSense Therapeutics (NASDAQ: NRSN) hat von der FDA positives Feedback zu ihrem Studiendesign der Phase 3 für PrimeC, ihren ALS-Behandlungs Kandidaten, erhalten. Nach einem Type-C-Gespräch mit der FDA plant das Unternehmen, ein endgültiges Protokoll im ersten Halbjahr 2025 einzureichen und die entscheidende Phase-3-Studie bis Mitte 2025 zu beginnen.
Die geplante Phase-3-Studie wird randomisiert, multicenter, multinational, doppelblind und placebokontrolliert sein und etwa 300 Patienten in einem Verhältnis von 2:1 (PrimeC zu placebo) umfassen. Die Studie wird eine 12-monatige Behandlungsperiode beinhalten, gefolgt von einer 12-monatigen offenen Verlängerung, bei der alle Teilnehmer PrimeC erhalten.
Diese Entwicklung folgt dem Abschluss ihrer klinischen PARADIGM-Studie der Phase 2b, in der PrimeC eine signifikante Auswirkung auf die Verlangsamung des Krankheitsverlaufs und die Erhöhung der Überlebensraten bei ALS-Patienten zeigte.
- Received positive FDA feedback on Phase 3 study design
- PrimeC demonstrated significant impact on disease progression and survival rates in previous trials
- Clear timeline established for Phase 3 study commencement in mid-2025
- Completed Phase 2b PARADIGM trial successfully
- Phase 3 trial won't start until mid-2025, indicating a lengthy timeline to potential commercialization
Insights
The FDA Type C meeting outcome for PrimeC represents a significant regulatory milestone for NeuroSense's ALS treatment program. The planned Phase 3 study design, involving 300 patients in a 2:1 ratio of PrimeC to placebo, demonstrates robust clinical trial methodology. The 12-month treatment period followed by an open-label extension provides comprehensive safety and efficacy data collection opportunities. This development is particularly noteworthy given the successful completion of the Phase 2b PARADIGM trial and the FDA's alignment on the pivotal study design. The 505(b)(2) pathway could potentially expedite the approval process, leveraging existing data to support the application. However, investors should note that Phase 3 initiation in mid-2025 indicates a lengthy timeline before potential commercialization.
For a micro-cap biotech with a market cap of
- The Type C meeting with the FDA, combined with the recent 18-month Phase 2b PARADIGM study readout, has the Company on track to commence a Phase 3 study in mid-2025
- PrimeC has already demonstrated a significant impact on slowing disease progression and increasing survival rates in people living with ALS
The FDA's positive feedback and guidance on overall trial design marks a noteworthy achievement for NeuroSense, as alignment on the design is a critical step in enabling the study to meet regulatory expectations and potentially provide sufficient data for the drug's approval.
In light of the FDA's feedback, NeuroSense plans to submit a final protocol to the FDA during the first half of 2025 with the aim of commencing enrollment of the pivotal Phase 3 study in mid-2025, which would include approximately 300 patients divided by a ratio of 2:1, PrimeC to placebo. The Phase 3 study is expected to be a randomized, multi-center, multinational, prospective, double-blind, placebo-controlled study, with an open label extension (OLE), to evaluate the efficacy and safety of PrimeC in people living with ALS. Following 12 months of treatment, it is expected that all participants will transition to PrimeC for a 12-month OLE.
"The feedback from the FDA regarding our clinical strategy for the planned pivotal Phase 3 study and the plan for submission of an eventual marketing application, represents a significant milestone in our drug development program. It validates the progress we've made and reinforces our commitment to advancing a potential therapeutic option for people living with ALS, whose need for innovative treatments is urgent. This step brings us closer to delivering a much-needed solution to the ALS community," stated Alon Ben-Noon, CEO of NeuroSense.
NeuroSense has already completed PARADIGM (NCT05357950), a multinational, randomized, double-blind, placebo-controlled Phase 2b clinical trial of PrimeC in 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
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
During the first 6 months of the trial, 45 participants were randomized to receive PrimeC, and 23 participants were randomized to receive placebo. This was followed by a 12-month open-label extension with all participants receiving PrimeC in a blinded manner, where neither the participants nor the clinical staff were aware of the initial treatment allocation.
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
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 submission of regulatory submissions to the FDA and the timing of commencement of enrollment for clinical trials, if any, and anticipated trial design. 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 commencement of enrollment for the Phase 3 trial, if any, or a delay in regulatory submissions with the FDA, the risk that the trial will not be completed, meet regulatory expectations or provide sufficient data for drug approval, unexpected changes in trial design, delay in submission by the Company of its regulatory dossier, that regulatory approvals for PrimeC will be delayed or not obtained in the
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FAQ
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