Mr. Mike Kelly reports
NERVGEN PHARMA ANNOUNCES FIRST SUBJECT DOSED IN LANDMARK PHASE 1B/2A CLINICAL TRIAL FOR NVG-291 IN SPINAL CORD INJURY
Nervgen Pharma Corp. has dosed the first subject in the company's landmark phase 1b/2a proof-of-concept placebo-controlled clinical trial for its proprietary lead compound, NVG-291, in individuals with spinal cord injury (SCI).
"This is a significant milestone for Nervgen and also an exciting day for individuals with spinal cord injury as we progress this first-in-kind product candidate into clinical studies," said Mike Kelly, Nervgen's president and chief executive officer. "This unique trial design will allow us to evaluate NVG-291's efficacy independently for each cohort of subjects -- subacute and chronic. We believe the results of this research study will be a key enabling step that may bring us closer to the first approved therapy for spinal cord injury, and we look forward to the prospect of delivering positive results next summer."
Given there are approximately 300,000 people with SCI living in the United States alone, the limited number of clinical trials in this area and the tremendous anticipation for this trial within the SCI community, recruitment for the chronic cohort (one to 10 years postinjury) is anticipated to happen relatively quickly, with results expected by mid-2024. Results from the subacute cohort (10 to 49 days postinjury) are expected in late 2024/early 2025. The trial is being conducted at Shirley Ryan AbilityLab in Chicago, a global leader in physical medicine and rehabilitation for adults and children with the most severe and complex conditions.
"Our team at Shirley Ryan AbilityLab is excited to have begun investigational treatment in this important clinical research trial in individuals with spinal cord injury," stated Dr. Monica A. Perez, PT, PhD, scientific chair of the Arms + Hands Lab at Shirley Ryan AbilityLab, professor of physical medicine and rehabilitation at Northwestern University, research scientist at the Edward Hines Jr. VA Hospital; and the principal investigator of this trial. "We look forward to fully recruiting this study and executing upon this innovative trial, which has the potential to change how we design and implement SCI clinical studies in the future."
About the NVG-291 phase 1b/2a trial
The 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 (one to 10 years postinjury) and subacute (10 to 49 days postinjury), 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 (magnetic resonance 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 become available. The trial is being partially financed by a grant from Wings for Life, which is to be provided in several milestone-based payments and will offset a portion of the direct costs of this clinical trial.
About Nervgen Pharma Corp.
Nervgen is a clinical-stage biotechnology company dedicated to developing innovative treatments that enable the nervous system to repair itself following damage, whether due to injury or disease. Nervgen's lead drug candidate, NVG-291, is being evaluated in a phase 1b/2a clinical trial. The company's initial target indication is spinal cord injury.
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