NeuroSense Announces Completion of PARADIGM Study Highlighting PrimeC's Significant Efficacy and Survival Benefits in ALS
NeuroSense Therapeutics has announced significant positive results from its 18-month PARADIGM study evaluating PrimeC for treating Amyotrophic Lateral Sclerosis (ALS). The study demonstrated that patients receiving PrimeC from the start showed a 33% slower disease progression (p=0.007) and a 58% improvement in survival rates compared to those who initially received placebo before switching to PrimeC.
The study revealed a notable difference of nearly 8 points in ALSFRS-R scores between the group treated with PrimeC for 18 months versus those who received placebo for 6 months before transitioning to PrimeC. The results will be presented at the 2024 International Symposium on ALS/MND by Prof. Merit Cudkowicz, with FDA meeting outcomes expected in the coming days.
NeuroSense Therapeutics ha annunciato risultati positivi significativi dal suo studio PARADIGM, della durata di 18 mesi, che valuta PrimeC nel trattamento della Sclerosi Laterale Amiotrofica (SLA). Lo studio ha dimostrato che i pazienti che ricevevano PrimeC fin dall'inizio mostravano una progressione della malattia più lenta del 33% (p=0.007) e un miglioramento del 58% nei tassi di sopravvivenza rispetto a quelli che inizialmente hanno ricevuto placebo prima di passare a PrimeC.
Lo studio ha rivelato una differenza notevole di quasi 8 punti nei punteggi ALSFRS-R tra il gruppo trattato con PrimeC per 18 mesi e quelli che hanno ricevuto placebo per 6 mesi prima di passare a PrimeC. I risultati saranno presentati al Simposio Internazionale sul SLA/MND 2024 dal Prof. Merit Cudkowicz, con i risultati dell'incontro con la FDA attesi nei prossimi giorni.
NeuroSense Therapeutics ha anunciado resultados positivos significativos de su estudio PARADIGM de 18 meses que evalúa PrimeC para el tratamiento de la Esclerosis Lateral Amiotrófica (ELA). El estudio demostró que los pacientes que recibieron PrimeC desde el principio mostraron una progresión de la enfermedad un 33% más lenta (p=0.007) y una mejora del 58% en las tasas de supervivencia en comparación con aquellos que inicialmente recibieron placebo antes de cambiar a PrimeC.
El estudio reveló una diferencia notable de casi 8 puntos en las puntuaciones ALSFRS-R entre el grupo tratado con PrimeC durante 18 meses frente a aquellos que recibieron placebo durante 6 meses antes de pasar a PrimeC. Los resultados se presentarán en el Simposio Internacional sobre ELA/MND 2024 por el Prof. Merit Cudkowicz, con los resultados de la reunión con la FDA esperados en los próximos días.
NeuroSense Therapeutics는 PrimeC의 근위축성 측삭 경화증(ALS) 치료에 대한 18개월 간의 PARADIGM 연구에서 중요하고 긍정적인 결과를 발표했습니다. 이 연구는 PrimeC를 처음부터 받은 환자들이 질병 진행 속도가 33% 느리다고 보여주었으며(p=0.007), PrimeC로 전환하기 전에 처음에 위약을 받은 환자들에 비해 생존율이 58% 향상되었다고 나타났습니다.
이 연구는 PrimeC로 18개월 치료받은 그룹과 6개월 동안 위약을 받은 후 PrimeC로 전환한 그룹 간의 ALSFRS-R 점수에서 거의 8점의 눈에 띄는 차이를 드러냈습니다. 결과는 2024년 ALS/MND 국제 심포지엄에서 Merit Cudkowicz 교수에 의해 발표될 예정이며, 곧 있을 FDA 회의 결과도 기다려지고 있습니다.
NeuroSense Therapeutics a annoncé des résultats positifs significatifs de son étude PARADIGM de 18 mois évaluant PrimeC pour le traitement de la Sclérose Latérale Amyotrophique (SLA). L'étude a démontré que les patients recevant PrimeC dès le début présentaient une progression de la maladie 33% plus lente (p=0.007) et une amélioration de 58% des taux de survie par rapport à ceux qui avaient d'abord reçu un placebo avant de passer à PrimeC.
L'étude a révélé une différence notable de près de 8 points dans les scores ALSFRS-R entre le groupe traité avec PrimeC pendant 18 mois et ceux qui ont reçu un placebo pendant 6 mois avant de passer à PrimeC. Les résultats seront présentés au Symposium International sur la SLA/MND 2024 par le Prof. Merit Cudkowicz, avec les résultats de la réunion avec la FDA attendus dans les prochains jours.
NeuroSense Therapeutics hat bedeutende positive Ergebnisse aus seiner 18-monatigen PARADIGM-Studie veröffentlicht, die PrimeC zur Behandlung der Amyotrophen Lateralsklerose (ALS) bewertet. Die Studie zeigte, dass Patienten, die von Anfang an PrimeC erhielten, eine 33% langsamere Krankheitsprogression (p=0.007) und eine 58% Verbesserung der Überlebensraten im Vergleich zu jenen, die zunächst ein Placebo erhielten, bevor sie zu PrimeC wechselten, aufwiesen.
Die Studie ergab einen bemerkenswerten Unterschied von fast 8 Punkten in den ALSFRS-R Scores zwischen der Gruppe, die 18 Monate lang mit PrimeC behandelt wurde, im Vergleich zu denjenigen, die zuvor 6 Monate lang ein Placebo erhalten hatten, bevor sie zu PrimeC wechselten. Die Ergebnisse werden auf dem Internationalen Symposium für ALS/MND 2024 von Prof. Merit Cudkowicz präsentiert, mit den Ergebnissen des FDA-Meetings, die in den kommenden Tagen erwartet werden.
- 33% reduction in disease progression with PrimeC treatment (p=0.007)
- 58% improvement in survival rates for patients on continuous PrimeC
- 8-point difference in ALSFRS-R scores favoring continuous PrimeC treatment
- None.
Insights
The PARADIGM study results for PrimeC represent a significant breakthrough in ALS treatment. The 33% reduction in disease progression (p=0.007) and 58% improvement in survival rates are remarkable outcomes in the ALS therapeutic landscape, where effective treatments are scarce.
The 8-point difference in ALSFRS-R scores between treatment groups is particularly noteworthy. The ALSFRS-R scale is the gold standard for measuring functional decline in ALS and such a substantial difference suggests meaningful clinical benefit. The strong statistical significance (p=0.007) adds considerable weight to these findings.
For a small-cap biotech company (
These clinical results could significantly strengthen NeuroSense's market position in the ALS therapeutic space. The global ALS treatment market, valued at approximately
The timing of these results, coinciding with the upcoming FDA meeting, could catalyze significant investor interest. For a micro-cap company, successful commercialization of PrimeC could drive substantial value creation. Investors should monitor the FDA meeting outcome closely, as positive regulatory feedback could trigger significant stock movement, particularly given the company's current modest market capitalization.
- In participants who received PrimeC from the start of the 18-month study compared to those initially on placebo before transitioning to PrimeC, disease progression was slowed by
33% (p=0.007), demonstrated in a58% improvement in survival rates - Consistent data across subgroups underscore the potential of PrimeC to redefine the standard of care in the treatment of ALS
The study revealed a significant difference of nearly 8 points in ALSFRS-R between the group treated with PrimeC for 18 months and the group that received placebo for 6 months before transitioning to PrimeC for 12 months. This difference seen between the groups represents a
The 18-month PARADIGM study results will be presented at the 2024 International Symposium on ALS/MND, taking place December 6-8, 2024, in
Additional results will be shared in due course.
The Company anticipates to update on the outcome of the meeting with the FDA in the next several days.
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 12 months readout, the study revealed a remarkable difference of 6.5 points in the ALS Functional Rating Scale-Revised (ALSFRS-R) between the group treated with PrimeC for 12 months and the group that received placebo for 6 months before transitioning to PrimeC. This represents a
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 regulatory filings, meetings and regulatory decisions. 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
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FAQ
What were the main results of NeuroSense's (NRSN) PARADIGM study for PrimeC in ALS treatment?
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