NervGen Pharma Provides Update on Phase 1b/2a Clinical Trial of NVG-291 in Spinal Cord Injury
NervGen Pharma Corp. (TSXV: NGEN) (OTCQB: NGENF) has announced that target enrollment for the chronic cohort in its Phase 1b/2a clinical trial of NVG-291 for spinal cord injury (SCI) is nearing completion. The study (NCT05965700) is a proof-of-concept, double-blind, randomized placebo-controlled trial. Mike Kelly, NervGen's President & CEO, expressed excitement about the progress but noted challenges in forecasting enrollment due to various factors and the study's novel design.
The company remains confident in advancing NVG-291 and will provide updates when enrollment is completed and when topline data is expected. NervGen plans to allow all subjects who have started the screening process when the 20-subject target is reached to enroll if they meet the criteria, potentially resulting in more than 20 subjects in the chronic cohort.
NervGen Pharma Corp. (TSXV: NGEN) (OTCQB: NGENF) ha annunciato che l'arruolamento del gruppo cronico nel suo studio clinico di Fase 1b/2a su NVG-291 per lesioni del midollo spinale (SCI) sta quasi per concludersi. Lo studio (NCT05965700) è un trial di proof-of-concept, in doppio cieco, randomizzato e controllato con placebo. Mike Kelly, Presidente e CEO di NervGen, ha espresso entusiasmo per i progressi, ma ha sottolineato le difficoltà nel prevedere l'arruolamento a causa di vari fattori e del design innovativo dello studio.
L'azienda rimane fiduciosa nel proseguire con NVG-291 e fornirà aggiornamenti quando l'arruolamento sarà completato e quando si aspetta di avere i dati principali. NervGen prevede di consentire a tutti i soggetti che hanno iniziato il processo di screening di iscriversi quando sarà raggiunto l'obiettivo di 20 soggetti, a condizione che soddisfino i criteri, potenzialmente portando a più di 20 soggetti nel gruppo cronico.
NervGen Pharma Corp. (TSXV: NGEN) (OTCQB: NGENF) ha anunciado que el reclutamiento objetivo para la cohorte crónica en su ensayo clínico de Fase 1b/2a de NVG-291 para lesiones de la médula espinal (SCI) está casi completo. El estudio (NCT05965700) es un ensayo de prueba de concepto, doble ciego, aleatorizado y controlado con placebo. Mike Kelly, Presidente y CEO de NervGen, expresó su entusiasmo por el progreso, pero mencionó los desafíos para prever el reclutamiento debido a varios factores y al diseño novedoso del estudio.
La empresa sigue confiando en avanzar con NVG-291 y proporcionará actualizaciones cuando se complete el reclutamiento y se esperen los datos preliminares. NervGen planea permitir que todos los sujetos que hayan comenzado el proceso de selección se inscriban cuando se alcance el objetivo de 20 sujetos, siempre que cumplan con los criterios, lo que podría resultar en más de 20 sujetos en la cohorte crónica.
NervGen Pharma Corp. (TSXV: NGEN) (OTCQB: NGENF)는 NVG-291의 만성 집단에 대한 임상 시험의 목표 등록이 거의 완료되었다고 발표했습니다. 척수 손상(SCI)을 위한 1b/2a 단계 임상 시험(NCT05965700)은 개념 증명, 이중 맹검, 무작위 배정 플라시보 통제 시험입니다. 마이크 켈리 NervGen의 사장 겸 CEO는 진전을 두고 흥미를 표명했지만, 다양한 요인과 연구의 혁신적인 설계로 인해 등록 예측에 어려움이 있다고 언급했습니다.
회사는 NVG-291을 발전시키는 데 자신감을 갖고 있으며, 등록이 완료되고 주요 데이터가 예상되는 시점에 업데이트를 제공할 예정입니다. NervGen은 20명의 대상 목표에 도달했을 때, 기준을 충족하는 경우 스크리닝 프로세스를 시작한 모든 피험자가 등록할 수 있도록 허용할 계획이며, 이는 만성 집단에 20명 이상이 등록될 가능성이 있습니다.
NervGen Pharma Corp. (TSXV: NGEN) (OTCQB: NGENF) a annoncé que le recrutement cible pour la cohorte chronique dans son essai clinique de Phase 1b/2a de NVG-291 pour les lésions de la moelle épinière (SCI) approchait de son achèvement. L'étude (NCT05965700) est un essai de preuve de concept, en double essai, randomisé et contrôlé par placebo. Mike Kelly, président et PDG de NervGen, a exprimé son enthousiasme quant aux progrès réalisés tout en notant les difficultés à prévoir le recrutement en raison de divers facteurs et du nouveau design de l'étude.
L'entreprise reste confiante dans l'avancement de NVG-291 et fournira des mises à jour lorsque le recrutement sera terminé et que les données principales seront attendues. NervGen prévoit de permettre à tous les sujets ayant commencé le processus de sélection de s'inscrire lorsque l'objectif de 20 sujets sera atteint, à condition qu'ils remplissent les critères, ce qui pourrait potentiellement entraîner plus de 20 sujets dans la cohorte chronique.
NervGen Pharma Corp. (TSXV: NGEN) (OTCQB: NGENF) hat angekündigt, dass die Zielanmeldung für die chronische Kohorte in seiner Phase 1b/2a-Studie zu NVG-291 bei Rückenmarkverletzungen (SCI) kurz vor dem Abschluss steht. Die Studie (NCT05965700) ist eine Machbarkeitsstudie, die doppelblind, randomisiert und placebokontrolliert ist. Mike Kelly, Präsident und CEO von NervGen, äußerte sich begeistert über die Fortschritte, wies jedoch auf Herausforderungen bei der Prognose der Anmeldungen hin, die auf verschiedene Faktoren und das neuartige Design der Studie zurückzuführen sind.
Das Unternehmen bleibt zuversichtlich, NVG-291 weiter voranzubringen, und wird Updates bereitstellen, wenn die Anmeldungen abgeschlossen sind und die Ergebnisse der Hauptdaten erwartet werden. NervGen plant, allen Probanden, die den Screening-Prozess begonnen haben, die Anmeldung zu ermöglichen, wenn das Ziel von 20 Probanden erreicht ist, vorausgesetzt, sie erfüllen die Kriterien, was potenziell zu mehr als 20 Probanden in der chronischen Kohorte führen könnte.
- Target enrollment for the chronic cohort in Phase 1b/2a trial of NVG-291 is close to completion
- Ongoing recruitment efforts continue to attract potential study participants
- Company remains confident in advancing NVG-291
- Challenges in forecasting enrollment due to multiple variables and novel study design
- Potential for enrollment to exceed the 20-subject target, which may impact study timeline and costs
- Target enrollment in the chronic cohort close to completion
Vancouver, British Columbia--(Newsfile Corp. - September 30, 2024) - NervGen Pharma Corp. (TSXV: NGEN) (OTCQB: NGENF), a clinical-stage biotech company dedicated to developing innovative solutions for the treatment of nervous system damage, today announced that target enrollment of the chronic cohort in its Phase 1b/2a proof-of-concept, double-blind, randomized placebo-controlled clinical trial (NCT05965700) for its proprietary investigational lead compound, NVG-291, in individuals with spinal cord injury (SCI) is approaching completion.
"We are excited to be near completion of enrollment in the chronic cohort of our Phase 1b/2a study in SCI," said Mike Kelly, NervGen's President & CEO. "Our ongoing recruitment efforts continue to attract potential study participants into the screening process, however, forecasting enrollment has been challenging given the many variables involved as well as the novel aspects of our study design and protocol."
Mr. Kelly continued, "We remain confident in our efforts to advance NVG-291 and will further advise when enrollment has completed and when topline data is expected.
"NervGen fully intends that all subjects who have initiated the screening process when our 20-subject target is achieved will be given the time to enroll in the study if they meet the entry criteria, potentially resulting in more than 20 subjects being enrolled in the chronic cohort."
About Phase 1b/2a Trial
The double-blind, placebo-controlled proof-of-concept trial (NCT05965700) will evaluate the efficacy of NVG-291 in two separate cohorts of individuals with cervical spinal cord injury: chronic (1-10 years post-injury) and subacute (those with a more recent injury), given demonstrated efficacy in preclinical models of both chronic and acute spinal cord injury. The trial is designed to evaluate 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, upper extremity dexterity and grasping and mobility, as well as changes in additional electrophysiological measurements. Each cohort 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 that 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 mechanisms that interfere with nervous system repair. NVG-291 is derived from the intracellular wedge domain of the receptor type protein tyrosine phosphatase sigma (PTPσ). NVG-291-R, a rodent analog of NVG-291, has been shown to promote nervous system repair and functional recovery in animal models of spinal cord injury (acute and chronic intervention), peripheral nerve injury, multiple sclerosis and stroke, through enhanced plasticity, axonal regeneration, and remyelination. 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 that enable the nervous system to repair in the settings of traumatic injury and disease. NervGen's lead drug candidate, NVG-291, is being evaluated in a Phase 1b/2a clinical trial in the company's initial target indication, spinal cord injury. The company 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, Corporate Communications
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. 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, timing, rate of subject enrollment, number of subjects, planned data readout and study design of the clinical development of NVG-291 including the Phase 1b/2a clinical trial in spinal cord injury; our intention to advise when enrollment has completed and when topline data is expected; the receipt of the milestone-based grant payments; the development plans and prospective target indications for NVG-300; and the creation of innovative treatments of nervous system damage due to trauma or disease.
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FAQ
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