NRx Pharmaceuticals (NASDAQ:NRXP) Announces Publication of Paper Entitled "Quality Assurance of Depression Ratings in Psychiatric Clinical Trials"
NRx Pharmaceuticals announced the publication of a paper in the American Journal of Clinical Psychopharmacology highlighting their improved methodology for depression rating quality assurance in clinical trials. The company developed an enhanced training and monitoring program for study site raters that achieved 94.5% concordance with central raters, allowing for a maximum variance of 3 points on a 60-point scale. This improved accuracy enabled their phase 2b/3 clinical trial of NRX-101 to achieve statistical significance with fewer than 100 participants, compared to the several hundred typically required. The methodology demonstrated significant improvements in measuring recovery from suicidality and reduction in akathisia.
NRx Pharmaceuticals ha annunciato la pubblicazione di un articolo sull'American Journal of Clinical Psychopharmacology che evidenzia la loro metodologia migliorata per la valutazione della qualità della depressione nei trial clinici. L'azienda ha sviluppato un programma di formazione e monitoraggio potenziato per i valutatori dei siti di studio, che ha raggiunto una concordanza del 94,5% con i valutatori centrali, consentendo una varianza massima di 3 punti su una scala di 60 punti. Questa accuratezza migliorata ha permesso al loro trial clinico di fase 2b/3 di NRX-101 di raggiungere significatività statistica con meno di 100 partecipanti, rispetto ai diversi centinaia normalmente richiesti. La metodologia ha dimostrato significativi miglioramenti nella misurazione del recupero dalla suicidialità e nella riduzione dell'acatisia.
NRx Pharmaceuticals anunció la publicación de un artículo en el American Journal of Clinical Psychopharmacology que destaca su metodología mejorada para la garantía de calidad en la evaluación de la depresión en ensayos clínicos. La compañía desarrolló un programa de capacitación y monitoreo mejorado para los evaluadores en los sitios de estudio, que logró una concordancia del 94,5% con los evaluadores centrales, permitiendo una variación máxima de 3 puntos en una escala de 60 puntos. Esta precisión mejorada permitió que su ensayo clínico de fase 2b/3 de NRX-101 alcanzara significación estadística con menos de 100 participantes, en comparación con los varios cientos que normalmente se requieren. La metodología demostró mejoras significativas en la medición de la recuperación de la suicidialidad y la reducción de la akatisia.
NRx Pharmaceuticals는 임상 시험에서 우울증 평가 품질 보증을 위한 개선된 방법론을 강조하는 논문이 American Journal of Clinical Psychopharmacology에 게재되었음을 발표했습니다. 회사는 연구 사이트 미터를 위한 향상된 교육 및 모니터링 프로그램을 개발하여 중앙 미터와 94.5%의 일치를 달성했고, 60점 척도에서 3점의 최대 변동성을 허용했습니다. 이러한 개선된 정확성 덕분에 NRX-101의 2b/3상 임상 시험이 일반적으로 수백 명이 필요한 것에 비해 100명 미만의 참가자로 통계적 유의성을 달성할 수 있었습니다. 이 방법론은 자살 위험에서의 회복 측정 및 아카티시아 감소에서 상당한 개선을 입증했습니다.
NRx Pharmaceuticals a annoncé la publication d'un article dans l'American Journal of Clinical Psychopharmacology soulignant leur méthodologie améliorée pour l'assurance qualité des évaluations de la dépression dans les essais cliniques. L'entreprise a développé un programme de formation et de suivi renforcé pour les évaluateurs sur les sites d'étude, atteignant une concordance de 94,5% avec les évaluateurs centraux, permettant une variance maximale de 3 points sur une échelle de 60 points. Cette précision améliorée a permis à leur essai clinique de phase 2b/3 pour NRX-101 d'atteindre une signification statistique avec moins de 100 participants, contre plusieurs centaines généralement nécessaires. La méthodologie a démontré des améliorations significatives dans la mesure de la récupération de la suicidabilité et de la réduction de l'akathisie.
NRx Pharmaceuticals hat die Veröffentlichung eines Artikels im American Journal of Clinical Psychopharmacology bekannt gegeben, der ihre verbesserte Methodik zur Qualitätssicherung von Depressionseinschätzungen in klinischen Studien hervorhebt. Das Unternehmen hat ein verbessertes Schulungs- und Überwachungsprogramm für die Prüfer an den Studienorten entwickelt, das eine Übereinstimmung von 94,5% mit den zentralen Prüfern erreichte und eine maximale Abweichung von 3 Punkten auf einer 60-Punkte-Skala zuließ. Diese verbesserte Genauigkeit ermöglichte es der Phase 2b/3-Studie von NRX-101, statistische Signifikanz mit weniger als 100 Teilnehmern zu erreichen, im Vergleich zu den mehreren Hundert, die normalerweise erforderlich sind. Die Methodik zeigte signifikante Verbesserungen bei der Messung der Genesung von Suizidalität und der Reduzierung von Akathisie.
- Achieved 94.5% concordance in depression ratings, significantly higher than industry standards
- Developed methodology enables smaller, more cost-effective clinical trials
- Successfully demonstrated statistical significance with only 90 patients versus hundreds typically required
- Methodology showed improved measurement of suicidality recovery and akathisia reduction
- None.
Insights
The publication of NRx's enhanced clinical trial methodology represents a significant advancement in psychiatric drug development. Their approach achieved 94.5% concordance with only 3 points variance, compared to industry standard of 6 points, enabling statistical significance with just 90 patients instead of hundreds typically required.
This breakthrough in rating reliability has substantial implications for future psychiatric drug trials:
- Reduced patient recruitment needs, potentially cutting trial costs by 50-70%
- Faster trial completion times
- Higher probability of successful trial outcomes
- Improved ability to detect true drug effects with smaller sample sizes
- NRx-developed training and monitoring methodology in recently completed phase 2b/3 clinical trial of NRX-101 documents higher interrater reliability (IRR) on primary endpoint (MADRS depression scale) than previously reported industry standards
- Positive implications for conduct of future registration trials for NRX-101 and similar medications.
- Published in the peer reviewed American Journal of Clinical Psychopharmacology
"The rater training and monitoring methodology achieved by NRx's research team enabled the team to identify statistically significant improvements in recovery from suicidality and reduction in akathisia (a potentially lethal side effect of antidepressant drugs) with a compact study design of 90 patients. This methodology enabled statistical significance to be achieved with fewer than 100 participants, where typically several hundred would have been required," said Dr. Jonathan Javitt, Chairman, CEO and Chief Scientist of NRx Pharmaceuticals and senior author of the study. "Clinical trials in antidepressant drugs rely on close coordination of human psychometric raters across study sites. Improving the reliability of this methodology increases our ability to bring new, lifesaving medicines to patients."
In the NRX-101 study, trial concordance, as defined by no more than 3 points of disagreement between site raters and central raters, was seen in
About NRx Pharmaceuticals, Inc.
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain, and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRx has recently announced plans to submit a New Drug Application for NRX-100 (IV ketamine) for the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a development stage healthcare delivery company developing a best-in-class network of precision psychiatry clinics that intends to offer ketamine transcranial magnetics stimulation (TMS) and other lifesaving therapies to patients with suicidal depression and related disorders, together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.
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For further information:
Matthew Duffy
Chief Business Officer, NRx Pharmaceuticals
Co-Chief Executive Officer, HOPE Therapeutics, Inc.
mduffy@nrxpharma.com
1 Sapko, et. al., J Clin Psychopharmacol, 2024 |
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SOURCE NRx Pharmaceuticals, Inc.
FAQ
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