NervGen Completes Dosing of First Subject in Subacute Cohort of its Phase 1b/2a Clinical Trial of NVG-291 in Spinal Cord Injury
NervGen Pharma has announced the dosing of its first subject in the subacute cohort of its Phase 1b/2a clinical trial for NVG-291, targeting spinal cord injury (SCI) treatment. The trial (NCT05965700) is designed as a proof-of-concept, double-blind, randomized placebo-controlled study.
The company has implemented protocol amendments for the subacute cohort, including revising the timing window to 20-90 days post-injury and reducing the number of visits and assessments to decrease participant burden. The trial evaluates efficacy in two separate cohorts: chronic and subacute cervical spinal cord injury.
Results for the chronic cohort, which has completed enrollment, are expected in Q2 2025. The company plans to continue enrollment in the subacute cohort throughout 2025.
NervGen Pharma ha annunciato la somministrazione della prima dose al soggetto nel gruppo subacuto del suo trial clinico di fase 1b/2a per NVG-291, mirato al trattamento delle lesioni del midollo spinale (SCI). Lo studio (NCT05965700) è progettato come uno studio di prova di concetto, in doppio cieco, randomizzato e controllato con placebo.
L'azienda ha implementato modifiche al protocollo per il gruppo subacuto, inclusa la revisione della finestra temporale a 20-90 giorni dopo l'infortunio e la riduzione del numero di visite e valutazioni per diminuire il carico sui partecipanti. La sperimentazione valuta l'efficacia in due gruppi separati: lesioni croniche e subacute del midollo spinale cervicale.
I risultati per il gruppo cronico, che ha completato l'arruolamento, sono attesi nel secondo trimestre del 2025. L'azienda prevede di continuare l'arruolamento nel gruppo subacuto per tutto il 2025.
NervGen Pharma ha anunciado la dosificación de su primer sujeto en el grupo subagudo de su ensayo clínico de fase 1b/2a para NVG-291, que se centra en el tratamiento de lesiones de médula espinal (SCI). El ensayo (NCT05965700) está diseñado como un estudio de prueba de concepto, doble ciego, aleatorizado y controlado con placebo.
La empresa ha implementado enmiendas al protocolo para el grupo subagudo, incluidas revisiones de la ventana temporal a 20-90 días después de la lesión y la reducción del número de visitas y evaluaciones para disminuir la carga sobre los participantes. El ensayo evalúa la eficacia en dos cohortes separadas: lesiones cervicales crónicas y subagudas de médula espinal.
Se esperan los resultados para la cohorte crónica, que ha completado el reclutamiento, en el segundo trimestre de 2025. La empresa planea continuar el reclutamiento en el grupo subagudo durante todo 2025.
NervGen Pharma는 척수 손상(SCI) 치료를 목표로 하는 NVG-291의 1b/2a 단계 임상 시험에서 준급성 집단의 첫 번째 피험자에 대한 투여를 발표했습니다. 이 시험(NCT05965700)은 개념 증명을 위한 더블 블라인드 무작위 대조군 연구로 설계되었습니다.
회사는 준급성 집단을 위한 프로토콜 개정을 시행했으며, 여기에는 부상 후 20-90일의 시간 창을 수정하고 방문 및 평가 횟수를 줄여 참가자의 부담을 줄이는 것이 포함됩니다. 이 시험은 만성 및 준급성 경추 척수 손상이라는 두 개의 별도 집단에서 효능을 평가합니다.
모집이 완료된 만성 집단의 결과는 2025년 2분기 중에 발표될 예정입니다. 회사는 2025년 내내 준급성 집단의 모집을 지속할 계획입니다.
NervGen Pharma a annoncé l'administration de la première dose à un sujet dans la cohorte subaiguë de son essai clinique de phase 1b/2a pour NVG-291, visant à traiter les lésions de la moelle épinière (SCI). L'essai (NCT05965700) est conçu comme une étude de preuve de concept, en double aveugle, randomisée et contrôlée par placebo.
L'entreprise a mis en œuvre des modifications de protocole pour la cohorte subaiguë, y compris une révision de la fenêtre temporelle à 20-90 jours après la blessure et une réduction du nombre de visites et d'évaluations pour diminuer la charge sur les participants. L'essai évalue l'efficacité dans deux cohortes distinctes : lésions cervicales chroniques et subaigües de la moelle épinière.
Les résultats de la cohorte chronique, qui a terminé le recrutement, sont attendus au deuxième trimestre 2025. L'entreprise prévoit de continuer le recrutement dans la cohorte subaiguë tout au long de 2025.
NervGen Pharma hat die Dosierung des ersten Probanden in der subakuten Kohorte seiner Phase 1b/2a klinischen Studie für NVG-291 bekannt gegeben, die auf die Behandlung von Rückenmarksverletzungen (SCI) abzielt. Die Studie (NCT05965700) ist als proof-of-concept, doppelblind, randomisierte Placebo-kontrollierte Studie konzipiert.
Das Unternehmen hat Protokolländerungen für die subakute Kohorte umgesetzt, einschließlich der Überarbeitung des Zeitfensters auf 20 bis 90 Tage nach der Verletzung und der Reduzierung der Anzahl der Besuche und Bewertungen, um die Belastung der Teilnehmer zu verringern. Die Studie bewertet die Wirksamkeit in zwei separaten Kohorten: chronische und subakute Verletzungen des zervikalen Rückenmarks.
Die Ergebnisse der chronischen Kohorte, die das Rekrutierungsziel erreicht hat, werden im 2. Quartal 2025 erwartet. Das Unternehmen plant, die Rekrutierung in der subakuten Kohorte bis 2025 fortzusetzen.
- First subject dosed in subacute cohort of Phase 1b/2a trial
- Chronic cohort enrollment completed with results expected Q2 2025
- Protocol amendments approved to facilitate enrollment and reduce participant burden
- None.
Vancouver, British Columbia--(Newsfile Corp. - February 6, 2025) - NervGen Pharma Corp. (TSXV: NGEN) (OTCQB: NGENF), a clinical-stage biotech company dedicated to developing neurorestorative therapeutics, today announced that the first subject has been enrolled and dosed in the subacute 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). The company previously reported the completion of enrollment of the chronic cohort and announced that results for the chronic cohort are expected in Q2 2025.
Recently, the company received IRB approval for an amendment focused on the subacute cohort of its Phase 1b/2a clinical trial. Key changes to the protocol were implemented to facilitate enrollment, for example, revising the timing of subacute SCI to 20 to 90 days post-injury, and to decrease the burden on study participants by reducing the number of visits and assessments.
"The efficacy of NVG-291 is being evaluated in two separate cohorts of individuals with cervical spinal cord injury, chronic and subacute, given the demonstrated efficacy in preclinical models of both chronic and acute SCI," said Daniel Mikol, MD, Ph.D., NervGen's Chief Medical Officer. "We are pleased to report that the first subject in the subacute cohort of our Phase 1b/2a clinical trial in traumatic SCI has been enrolled and dosed. We believe that the protocol amendment will enhance enrollment and result in a better overall experience for participants, particularly by reducing burden as individuals enrolled in this cohort are close to the time of their injury and will still be receiving standard of care rehabilitation."
"As we begin the year, our team is on track to report data on the chronic cohort in the second quarter and to advance the enrollment in the subacute cohort throughout 2025," said Mike Kelly, NervGen's President & CEO. "We truly believe that this will be a pivotal year for NervGen and we look forward to further advancing NVG-291 towards our end goal of helping individuals with SCI."
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 and exploratory 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.
Contacts
Huitt Tracey, Investor Relations
htracey@nervgen.com
604.537.2094
Bill Adams, Chief Financial Officer
info@nervgen.com
778.731.1711
David Schull or Ignacio Guerrero-Ros, Ph.D.
Russo Partners
david.schull@russopartnersllc.com
ignacio.guerrero-ros@russopartnersllc.com
858.717.2310
646.942.5604
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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 (collectively, "forward-looking statements"). Such forward-looking statements 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 NervGen; 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
When will NervGen (NGENF) release results for the chronic cohort of NVG-291 trial?
What changes were made to NervGen's subacute SCI trial protocol?
What type of clinical trial is NervGen conducting for NVG-291?
How many cohorts are included in NervGen's NVG-291 spinal cord injury trial?
