NervGen Pharma to Present Topline Data for NVG-291 Phase 1b/2a Chronic Cohort Study at the American Spinal Injury Association Annual Scientific Meeting
NervGen Pharma (OTCQB: NGENF) announced it will present topline results from the chronic cohort of its Phase 1b/2a study of NVG-291 at the 52nd American Spinal Injury Association Annual Scientific Meeting in June 2025. The presentation will cover data from their initial proof-of-concept, double-blind, placebo-controlled clinical trial in spinal cord injury (SCI). The study incorporated both clinical and electrophysiological assessments to maximize the probability of observing efficacy signals. Dr. Daniel Mikol, NervGen's Chief Medical Officer, will present the findings on June 3, 2025, during the Clinical Trial Updates session in Scottsdale, Arizona.
NervGen Pharma (OTCQB: NGENF) ha annunciato che presenterà i risultati principali dalla coorte cronica del suo studio di Fase 1b/2a su NVG-291 durante il 52º Congresso Annuale della American Spinal Injury Association a giugno 2025. La presentazione includerà i dati del loro primo trial clinico di prova di concetto, in doppio cieco e controllato con placebo, nel campo delle lesioni del midollo spinale (SCI). Lo studio ha integrato valutazioni cliniche ed elettrofisiologiche per aumentare le probabilità di rilevare segnali di efficacia. Il dottor Daniel Mikol, Chief Medical Officer di NervGen, illustrerà i risultati il 3 giugno 2025 durante la sessione Clinical Trial Updates a Scottsdale, Arizona.
NervGen Pharma (OTCQB: NGENF) anunció que presentará los resultados principales de la cohorte crónica de su estudio de Fase 1b/2a de NVG-291 en la 52ª Reunión Científica Anual de la American Spinal Injury Association en junio de 2025. La presentación incluirá datos de su ensayo clínico inicial de prueba de concepto, doble ciego y controlado con placebo en lesiones de la médula espinal (SCI). El estudio incorporó evaluaciones clínicas y electrofisiológicas para maximizar la probabilidad de detectar señales de eficacia. El Dr. Daniel Mikol, Director Médico de NervGen, presentará los hallazgos el 3 de junio de 2025 durante la sesión de Actualizaciones de Ensayos Clínicos en Scottsdale, Arizona.
NervGen Pharma (OTCQB: NGENF)는 2025년 6월에 열리는 제52회 미국 척수손상학회 연례 학술대회에서 NVG-291의 만성 코호트에 대한 1b/2a상 연구 주요 결과를 발표할 예정입니다. 이번 발표에서는 척수 손상(SCI)에 대한 초기 개념 증명, 이중 맹검, 위약 대조 임상시험 데이터를 다룰 예정입니다. 연구는 임상 및 전기생리학적 평가를 포함하여 효능 신호 관찰 가능성을 극대화했습니다. NervGen의 최고 의료책임자인 Daniel Mikol 박사가 2025년 6월 3일 애리조나 주 스코츠데일에서 열리는 임상시험 업데이트 세션에서 결과를 발표할 것입니다.
NervGen Pharma (OTCQB : NGENF) a annoncé qu'elle présenterait les résultats principaux de la cohorte chronique de son étude de phase 1b/2a sur NVG-291 lors de la 52e réunion scientifique annuelle de l'American Spinal Injury Association en juin 2025. La présentation portera sur les données de leur premier essai clinique en double aveugle, contrôlé par placebo, visant à prouver le concept dans les lésions de la moelle épinière (SCI). L'étude a intégré des évaluations cliniques et électrophysiologiques afin de maximiser la probabilité d'observer des signaux d'efficacité. Le Dr Daniel Mikol, directeur médical de NervGen, présentera les résultats le 3 juin 2025 lors de la session Clinical Trial Updates à Scottsdale, Arizona.
NervGen Pharma (OTCQB: NGENF) gab bekannt, dass es die Hauptergebnisse der chronischen Kohorte seiner Phase 1b/2a-Studie zu NVG-291 auf dem 52. Jahrestreffen der American Spinal Injury Association im Juni 2025 vorstellen wird. Die Präsentation umfasst Daten aus ihrer ersten Proof-of-Concept, doppelblinden, placebokontrollierten klinischen Studie bei Rückenmarksverletzungen (SCI). Die Studie beinhaltete sowohl klinische als auch elektrophysiologische Bewertungen, um die Wahrscheinlichkeit der Erkennung von Wirksamkeitssignalen zu maximieren. Dr. Daniel Mikol, Chief Medical Officer von NervGen, wird die Ergebnisse am 3. Juni 2025 während der Sitzung „Clinical Trial Updates“ in Scottsdale, Arizona, präsentieren.
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Vancouver, British Columbia--(Newsfile Corp. - May 21, 2025) - NervGen Pharma Corp. (TSXV: NGEN) (OTCQB: NGENF), a clinical-stage biotechnology company dedicated to developing neuroreparative therapeutics, today announced that topline results from the chronic cohort of the ongoing Phase 1b/2a study of NVG-291 will be presented as an oral presentation at the 52nd American Spinal Injury Association Annual Scientific Meeting being held June 2-4, 2025 in Scottsdale, AZ.
"We are looking forward to completing the data analysis, unblinding the data, and presenting the first results from the chronic cohort in this initial proof-of-concept, double-blind, placebo-controlled clinical trial of NVG-291 in spinal cord injury ("SCI")," stated Daniel Mikol, MD, Ph.D., NervGen's Chief Medical Officer. "In this trial we have incorporated both clinical assessments as well as electrophysiological assessments of connectivity, as we feel this gives the highest probability of observing and characterizing an efficacy signal with NVG-291. We are hopeful that the results of the chronic cohort of our Phase 1b/2a trial may demonstrate, for the first time, the potential for NVG-291 to enable neural repair in individuals with SCI and will support further investigation of NVG-291 in SCI."
Presentation Details:
Presenting Author: Daniel Mikol MD, Ph.D., Chief Medical Officer, NervGen
Presentation Title: A 16-week Placebo-controlled Phase 1b/2a Study of NVG-291: Results for the Chronic Cohort
Session Name: General Session 6: Clinical Trial Updates: Clinical Trials: What's the Latest and When Will it Get Here?
Session Date: Tuesday, June 3, 2025
Session Time: 10:40 AM-11:40 AM MST
Location: Arizona Ballroom I, Grand Hyatt Scottsdale Resort, 7500 E. Doubletree Ranch Rd., Scottsdale, AZ
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 is licensed from Case Western Reserve University and is based on academic studies that demonstrated the preclinical efficacy of NVG-291-R, the rodent prototype of NVG-291, in animal models of spinal cord injury. These studies implicated several potential molecular and cellular mechanisms by which NVG-291-R promotes neurorepair and functional improvement in both central and peripheral nervous system injury models. The implicated mechanisms include the promotion of neuronal sprouting, or plasticity, remyelination, and promotion of a non-inflammatory phenotype in the microglial cells. NervGen has received Fast Track designation from the FDA for NVG-291 in individuals with spinal cord injury.
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 motor incomplete 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 safety and efficacy of a fixed dose of NVG-291 using electrophysiological and MRI imaging measures, functional clinical outcome measures, and blood biomarkers that together will provide comprehensive information about the extent of recovery of somatic and autonomic function post-injury. Specifically, the primary objective seeks to assess changes in corticospinal connectivity of defined upper and lower extremity muscle groups following treatment, based on changes in motor evoked potential amplitudes. Secondary objectives evaluate changes in multiple clinical outcome assessments focusing on motor function, upper extremity dexterity, grasping and immobility, and additional electrophysiological measurements. The cohorts will be comprised of 20 subjects each and will be evaluated independently in a blinded manner 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. More information about participation in the subacute study is available at www.connectscistudy.com.
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 candidate, NVG-291, in a Phase 1b/2a clinical trial in spinal cord injury and has initiated preclinical test of concept evaluation of our pipeline candidate, NVG-300, in models of ischemic stroke and spinal cord injury. For more information, visit www.nervgen.com and follow NervGen on X and LinkedIn for the latest news on the company.
Contacts
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htracey@nervgen.com
604.537.2094
Bill Adams, Chief Financial Officer
info@nervgen.com
778.731.1711
Christy Curran
Sam Brown Healthcare Communications
christycurran@sambrown.com
615.414.8668
646.942.5604
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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 subject matter to be presented at the upcoming conference; 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; the future development plans and benefits of NVG-291; the development plans and prospective target indications for NVG-300; the receipt of the milestone-based grant payments; and the creation of neuroreparative therapeutics to promote nervous system repair in settings of neurotrauma and neurologic disease.
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