NervGen Completes Enrollment in Chronic Cohort of its Phase 1b/2a Clinical Trial of NVG-291 in Spinal Cord Injury
NervGen Pharma has completed enrollment of 20 subjects in the chronic cohort of its Phase 1b/2a clinical trial for NVG-291, its lead candidate for spinal cord injury (SCI) treatment. The company expects to release topline data in Q2 2025 after completing data collection, review, database lock, unblinding, and analysis.
The company has also received IRB approval for a protocol amendment and begun screening subjects for the subacute cohort. The trial (NCT05965700) is designed as a proof-of-concept, double-blind, randomized placebo-controlled study.
Management believes their experience from recruiting the chronic cohort, combined with the recently approved protocol amendment, will improve the recruitment process for the subacute cohort while reducing the burden on participants.
NervGen Pharma ha completato l'arruolamento di 20 soggetti nel gruppo cronico del suo trial clinico di fase 1b/2a per NVG-291, il suo principale candidato per il trattamento delle lesioni del midollo spinale (SCI). L'azienda prevede di rilasciare i dati preliminari nel secondo trimestre del 2025, dopo aver completato la raccolta dei dati, la revisione, il blocco del database, l'apertura delle buste e l'analisi.
L'azienda ha anche ricevuto l'approvazione dell'IRB per una modifica del protocollo e ha iniziato a selezionare i soggetti per il gruppo subacuto. Lo studio (NCT05965700) è progettato come uno studio di prova di concetto, in doppio cieco, randomizzato e controllato con placebo.
La direzione crede che la loro esperienza nell'arruolamento del gruppo cronico, combinata con la recente approvazione della modifica del protocollo, migliorerà il processo di reclutamento per il gruppo subacuto, riducendo al contempo il carico sui partecipanti.
NervGen Pharma ha completado la inscripción de 20 sujetos en la cohorte crónica de su ensayo clínico de fase 1b/2a para NVG-291, su principal candidato para el tratamiento de lesiones en la médula espinal (SCI). La empresa espera publicar datos preliminares en el segundo trimestre de 2025, tras completar la recolección de datos, la revisión, el bloqueo de la base de datos, la apertura de las cajas y el análisis.
La empresa también ha recibido la aprobación del IRB para una modificación del protocolo y ha comenzado a seleccionar sujetos para la cohorte subaguda. El ensayo (NCT05965700) está diseñado como un estudio de prueba de concepto, doble ciego, aleatorizado y controlado con placebo.
La gerencia cree que su experiencia en el reclutamiento de la cohorte crónica, combinada con la reciente aprobación de la modificación del protocolo, mejorará el proceso de reclutamiento para la cohorte subaguda y reducirá la carga sobre los participantes.
NervGen Pharma는 척수 손상(SCI) 치료를 위한 주요 후보 물질인 NVG-291의 1b/2a 단계 임상 시험의 만성 집단에 20명의 피험자를 모집 완료했습니다. 이 회사는 데이터 수집, 검토, 데이터베이스 잠금, 블라인드 해제 및 분석을 완료한 후 2025년 2분기에 주요 데이터를 발표할 예정입니다.
회사는 프로토콜 수정 사항에 대해 IRB 승인을 받았고, 아급성 집단의 피험자 선별을 시작했습니다. 이 시험(NCT05965700)은 개념 증명, 이중 맹검, 무작위 대조군 시험으로 설계되었습니다.
경영진은 만성 집단의 모집 경험과 최근에 승인된 프로토콜 수정을 결합하여 아급성 집단의 모집 프로세스가 개선되고 참가자에게 부담이 줄어들 것이라고 믿고 있습니다.
NervGen Pharma a terminé le recrutement de 20 sujets dans la cohorte chronique de son essai clinique de phase 1b/2a pour NVG-291, son candidat principal pour le traitement des lésions de la moelle épinière (SCI). L'entreprise prévoit de publier des données préliminaires au deuxième trimestre 2025 après avoir terminé la collecte de données, la révision, le verrouillage de la base de données, le déblinding et l'analyse.
L'entreprise a également obtenu l'approbation de l'IRB pour une modification du protocole et a commencé le dépistage des sujets pour la cohorte subaigue. L'essai (NCT05965700) est conçu comme une étude de preuve de concept, en double aveugle, randomisée et contrôlée par placebo.
La direction pense que leur expérience dans le recrutement de la cohorte chronique, combinée à la récente approbation de la modification du protocole, améliorera le processus de recrutement pour la cohorte subaigue tout en réduisant la charge pour les participants.
NervGen Pharma hat die Rekrutierung von 20 Probanden in der chronischen Kohorte seiner Phase 1b/2a-Studie für NVG-291, seinen wichtigsten Kandidaten zur Behandlung von Rückenmarksverletzungen (SCI), abgeschlossen. Das Unternehmen erwartet, die vorläufigen Ergebnisse im 2. Quartal 2025 nach Abschluss der Datenerhebung, Überprüfung, Datenbanksperrung, Aufhebung der Verblindung und Analyse zu veröffentlichen.
Das Unternehmen hat auch die Genehmigung der IRB für eine Protokolländerung erhalten und mit der Rekrutierung von Probanden für die subakute Kohorte begonnen. Die Studie (NCT05965700) ist als proof-of-concept, doppelblinde, randomisierte placebo-kontrollierte Studie konzipiert.
Das Management glaubt, dass ihre Erfahrungen bei der Rekrutierung der chronischen Kohorte in Kombination mit der kürzlich genehmigten Protokolländerung den Rekrutierungsprozess für die subakute Kohorte verbessern und die Belastung der Teilnehmer reduzieren werden.
- Completed enrollment of 20 subjects in chronic cohort of Phase 1b/2a trial
- Received IRB approval for protocol amendment
- Initiated screening for subacute cohort
- None.
- Topline data from the chronic cohort is expected in Q2 2025
- Institutional Review Board (IRB) protocol amendment changes approved, and screening has been initiated for subacute cohort
This news release constitutes a "designated news release" for the purposes of NervGen's prospectus supplement dated December 19, 2024 to its short form base shelf prospectus dated November 25, 2024.
Vancouver, British Columbia--(Newsfile Corp. - January 2, 2025) - NervGen Pharma Corp. (TSXV: NGEN) (OTCQB: NGENF), a clinical-stage biotech company dedicated to developing neurorestorative therapeutics, today announced that it has enrolled the 20th and final subject in the chronic cohort of its Phase 1b/2a proof-of-concept, double-blind, randomized placebo-controlled clinical trial (NCT05965700) evaluating its lead candidate, NVG-291, in individuals with spinal cord injury (SCI). Furthermore, the company has received IRB approval for an amendment to its Phase 1b/2a clinical trial and has initiated the screening of subjects for the subacute cohort of the study.
"We are pleased to share that enrollment is complete in the chronic cohort of our Phase 1b/2a clinical trial in traumatic spinal cord injury," said Daniel Mikol, MD, Ph.D., NervGen's Chief Medical Officer. "Following the conclusion of the 16-week trial for the last enrolled patient, we can proceed with the next step, which is to ensure all data are thoroughly collected, and reviewed, including database lock, unblinding, and in-depth analysis of the results. When these critical steps are completed, we anticipate announcing topline results in the second quarter of this year."
"Completing enrollment for the chronic cohort is an exciting and critical milestone for NervGen," said Mike Kelly, NervGen's President & CEO. "The team will now shift its focus to enrolling subjects in the subacute cohort. We believe our experience over the past year in recruiting for the chronic cohort together with the recently approved protocol amendment for the subacute cohort should help improve the recruitment process for this second cohort in addition to making the study less burdensome for participants."
Mr. Kelly added, "This milestone is a great way to start the year as we continue to advance our clinical development efforts. We've made significant progress in 2024 and 2025 is poised to be a pivotal year for both NervGen and the SCI community. We remain fully committed to advancing NVG-291 through the clinical and regulatory process with a goal to eventually make it widely available to individuals living with SCI, the vast majority of whom remain without any therapeutic options."
About Phase 1b/2a Trial
The double-blind, placebo-controlled proof-of-concept Phase 1b/2a clinical trial (NCT05965700) evaluates the safety and efficacy of NVG-291 in two separate cohorts of individuals with cervical spinal cord injury: chronic (1-10 years post-injury) and subacute (20-90 days post-injury), given demonstrated efficacy in preclinical models of both chronic and acute spinal cord injury. The trial is designed to evaluate the efficacy of a fixed dose of NVG-291 using multiple clinical outcome measures as well as objective electrophysiological and MRI imaging measures and blood biomarkers that together will provide comprehensive information about the extent of recovery of function, with a focus on improvements in motor function. Specifically, the primary objective is to assess the change in corticospinal connectivity of defined upper and lower extremity muscle groups following treatment based on changes in motor evoked potential amplitudes. Secondary objectives are to evaluate changes in a number of clinical outcome assessments focusing on motor function and strength, as well as changes in additional electrophysiological measurements. The cohorts will be comprised of approximately 20 subjects each and will be evaluated independently as the data becomes available. The trial is being partially funded by a grant from Wings for Life, which is being provided in several milestone-based payments and will offset a portion of the direct costs of this clinical trial.
About NVG-291
NervGen holds exclusive worldwide rights to NVG-291, a first-in-class therapeutic peptide targeting nervous system repair. NVG-291's technology was licensed from Case Western Reserve University and is based on academic studies demonstrating the preclinical efficacy of NVG-291-R, the rodent prototype of NVG-291, in animal models of spinal cord injury. Effects of NVG-291-R reported in multiple independent academic studies include the promotion of neuroplasticity, remyelination, anti-inflammatory polarization of microglia, and functional improvement in preclinical models of spinal cord injury, stroke, and peripheral nervous system injury. NVG-291 has received Fast Track designation in spinal cord injury from the U.S. Food and Drug Administration.
About NervGen
NervGen (TSXV: NGEN, OTCQB: NGENF) is a clinical-stage biotech company dedicated to developing innovative treatments to promote nervous system repair in settings of neurotrauma and neurologic disease. The company is testing the clinical efficacy of its lead molecule, NVG-291, in a Phase 1b/2a clinical trial in spinal cord injury and has initiated preclinical evaluation of a new development candidate, NVG-300, in models of ischemic stroke, amyotrophic lateral sclerosis (ALS) and spinal cord injury. For more information, visit www.nervgen.com and follow NervGen on X, LinkedIn, and Facebook for the latest news on the company.
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Cautionary Note Regarding Forward-Looking Statements
This news release may contain "forward-looking information" and "forward-looking statements" within the meaning of applicable Canadian and United States securities legislation. Such forward-looking statements and information herein include but are not limited to, the company's current and future plans, expectations and intentions, results, levels of activity, performance, goals or achievements, or any other future events or developments constitute forward-looking statements, and the words "may", "will", "would", "should", "could", "expect", "plan", "intend", "trend", "indication", "anticipate", "believe", "estimate", "predict", "likely" or "potential", or the negative or other variations of these words or other comparable words or phrases, are intended to identify forward-looking statements. Forward-looking statements include, without limitation, statements relating to: the objectives, planned clinical endpoints, timing, expected rate of enrollment, and timing of data readout and study design of our Phase 1b/2a clinical trial of NVG-291 in individuals with spinal cord injury; our belief that our experience and approved protocol amendment should improve the recruitment process and make the study less burdensome for the subacute cohort participants; our belief that 2025 is poised to be a pivotal year for both NervGen and the SCI community; the development plans, timelines, expected benefits, and prospective target indications for NVG-300; the receipt of the milestone-based grant payments; and the creation of neurorestorative therapeutics to promote nervous system repair in settings of neurotrauma and neurologic disease.
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FAQ
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