Breakthrough Clinical Results
NervGen Pharma Corp. announced a leadership transition with Dr. Adam Rogers appointed as Interim CEO, following the positive topline results from the chronic cohort of the CONNECT SCI study for its lead drug candidate, NVG-291. The study demonstrated strong efficacy in treating chronic spinal cord injury (SCI). NervGen will now focus on further data analysis, regulatory discussions, and advancing NVG-291 towards commercialization. The company also holds Fast Track designation from the FDA and Orphan Designation from the EMA for NVG-291 in individuals with SCI.
Key Highlights
- Positive topline results from the chronic cohort of the CONNECT SCI study for NVG-291 in chronic spinal cord injury.
- Appointment of Dr. Adam Rogers as Interim CEO.
- NVG-291 has received Fast Track designation from the FDA and Orphan Designation from the EMA.
- Continued analysis of data and engagement in regulatory discussions are planned.
Incidence and Prevalence
Latest Estimates of Spinal Cord Injury Incidence and Prevalence Globally
Global Overview
The most recent data indicates significant variations in spinal cord injury (SCI) metrics worldwide. According to international findings, global prevalence rates of spinal cord injury range from 11 to 112 per 100,000 population.
The 2019 Global Burden of Disease Study (published 2023) revealed a significant increase in the global incidence and burden of years lived with disability (YLDs) of spinal cord injuries in 2019 compared to 1990. This study also identified falls as the primary cause of spinal cord injuries globally.
Regional Data
China
In China, the incidence of spinal injuries in 2019 was 16.47 per 100,000 population (95% uncertainty interval: 12.08-22.00), with a prevalence of 358.30 per 100,000 population. From 1990 to 2019, the number of patients with spinal injuries in China increased by 138.32%, from 2.14 million to 5.10 million. The age-standardized prevalence increased from 0.20% to 0.27%.
United States
An older study from 1993 found the prevalence rate of traumatic spinal cord injury in the United States to be 721 cases per million people (equivalent to 72.1 per 100,000).
South Africa
A 2016 South African study found a crude incidence rate of traumatic spinal cord injury of 75.6 per million (95% CI: 64.3-88.8). In this population, assault was the main cause of injury (59.3%), followed by motor vehicle accidents (26.3%).
Taiwan
A 2012 Taiwanese study analyzing data from 1998-2008 found an overall national incidence of adult SCI of 246 per million-person-year. Of the 41,586 newly established diagnoses of SCI identified, 61.2% were traumatic.
Demographic Patterns
Males consistently show higher incidence rates of spinal cord injuries compared to females across studies. In South Africa, the male to female ratio was 5.9:1, while in Taiwan, males were more likely to have SCI (HR=1.52).
Age is also a significant factor. In Taiwan, compared to the age group of 20-39 years, the 40-59-year-old group and those aged ≥60 years were more likely to have SCI (HR=1.66 and 2.12, respectively). Conversely, a Chinese study found that the frequencies of SCIs decreased from 53.1% to 24.6% with increasing age.
Pediatric Incidence
In the pediatric population, the overall SCI incidence rate is 5.99 per 100,000 person-years, with traumatic cervical SCI accounting for the majority. The incidence rates of cervical, thoracic, lumbar, and other SCI in children were 4.06, 0.34, 0.75, and 0.85 per 100,000 person-years, respectively.
Future Trends
Trend projections up to 2030 revealed a slight decrease in age-standardized incidence rates (ASIR) for males, but an upward trend in age-specific incidence rates for both sexes. A similar upward pattern was observed in age-standardized YLD rates.
Economic Burden
Economic Burden of Treating Spinal Cord Injury in USA and Europe
United States
In the United States, more than 200,000 individuals live with chronic spinal cord injury (SCI), creating a significant economic burden beyond the physiological, psychological, and social suffering. A 2014 study using Medicaid data revealed adjusted mean expenditures of $47,518 for SCI patients with neuropathic pain (SCI-NeP) compared to $30,150 for SCI-only patients, representing incremental costs of $17,369. Factors significantly associated with increased cost included SCI type, trauma-related SCI, and comorbidity burden.
A 2015 MarketScan database study demonstrated that patients with SCI-associated neuropathic pain had significantly higher healthcare utilization over 12 months compared to SCI-only patients, including more inpatient admissions (27.4% vs 22.1%), emergency department visits (36.7% vs 26.4%), and office visits (mean: 13.0 vs 9.5). The adjusted incremental costs were $22,545 per patient with SCI-associated neuropathic pain during the 12-month period.
For specific procedures, a 2018 study found the 5-year cost of two-level cervical disc procedures was $130,417 for cervical disc replacement and $116,717 for anterior cervical discectomy and fusion.
Insurance and Long-term Impact
Patients with SCI face increased risk for loss of insurance coverage. A 2015 study found that the median duration of existing insurance coverage was only 20.2 months for those with traumatic SCI, compared to 48.0 months for matched controls.
Cost Reduction Strategies
A 2019 Australian study demonstrated that direct transfer to specialist spinal cord injury units for patients with acute traumatic SCI resulted in lower treatment costs, shorter length of stay, and less costly complications. The median cost per patient was AUD$45,473, and reducing indirect transfers by just 10% yielded cost savings of AUD$3.1 million (average per patient saving of AUD$5,861).
Volume-dependent intermittent catheterization (VDIC) has shown economic advantages over time-dependent approaches, with approximately 46% lower total costs.
Canadian Perspective
A 2020 study from Ontario estimated the net lifetime cost of SCI at $336,000 per person, with most costs occurring in the first year. This figure rises to $479,600 for individuals with a concurrent pressure ulcer at initial hospitalization. Costs were also higher for individuals with cervical or thoracic injury or requiring inpatient rehabilitation.
Projected Costs
As the SCI population ages, cost distribution is expected to shift from acute and medical care to less acute, community-based care. A 1989 Australian projection estimated that based on an incidence rate of 25 new cases per million population annually, the annual cost by 2006 would exceed $250 million.
Study Design Parameters
Study Design Parameters and Endpoints in Key Spinal Cord Injury Trials
Study Designs
Key spinal cord injury (SCI) trials employ diverse methodologies including prospective clinical trials with randomization to treatment conditions such as acupuncture or Trager Psychophysical Integration. Some studies utilize subjects as their own controls through 5-week pretreatment baseline and 5-week posttreatment follow-up periods. Other approaches include retrospective studies examining epidemiological features, feasibility studies for wheelchair maintenance programs, and Modified Delphi panel approaches using expert consensus.
Study Settings and Populations
Research typically occurs in rehabilitation hospital research departments, spinal cord injury research centers, and urban teaching hospitals with neurotrauma facilities. Study populations commonly include patients with chronic SCI who use manual wheelchairs, adults with traumatic spinal cord injury, and patients with traumatic spinal injuries (TSI) requiring inpatient care.
Interventions
Interventions range from ten acupuncture or 10 Trager treatments over 5-week periods to peer-led manual wheelchair skills maintenance training. Some trials investigate multimodal intraoperative neurophysiological monitoring including somatosensory and motor evoked potentials, while others examine non-surgical interventions like spinal manipulative therapy and neural mobilization exercises.
Primary Outcome Measures
Primary endpoints include Performance-corrected Wheelchair User's Shoulder Pain Index (PC-WUSPI) scores, wheelchair maintenance knowledge tests, total rolling resistance measurements, visual analog scale for pain, and Frankel scale for neurologic status. The American Spinal Injury Association Impairment Scale serves as a critical neurological examination measure, alongside MRI criteria in cellular therapy trials.
Secondary Outcome Measures
Secondary measures encompass functional assessments like the 3-cone test and 6-min push test, participant confidence in wheelchair maintenance, and neurologic symptoms. Additional measures include the Spinal Cord Independence Measure (SCIM), Spinal Cord Ability Realization Measurement Index (SCI-ARMI), Needs Assessment Checklist, Short Form 36 General Health Survey (SF-36), and Aberdeen Pain Index (ABPI). For pain management studies, the McGill Pain Questionnaire (MPQ) and analgesic consumption are commonly utilized.
Assessment Methods
Trials employ analysis of variance for outcome measure changes, clinical neurological indices (Glasgow Coma Scale, post-traumatic amnesia), and various neuroimaging techniques. Neuropsychological tests assess attention, processing speed, memory, and executive function. Some studies utilize frequentist random effects network meta-analysis with evidence confidence evaluated using the CINEMA method.
Evaluation Tools
Neurological assessment relies on scales like ASIA motor score, ASIA light touch scores, and ASIA pinprick scores. Functional outcomes are measured via the Barthel index and Activities of Daily Living (ADL) scores. Imaging modalities include Functional Magnetic Resonance Imaging (fMRI), Spinal cord fMRI (scfMRI), Doppler ultrasonography, venography, computed tomography, and ventilation-perfusion scans.
Key trials have demonstrated significant decreases in pain scores and statistically significant improvements in wheelchair maintenance knowledge, highlighting the potential efficacy of various interventions for SCI patients.
NVG-291 Clinical Trials Beyond Spinal Cord Injury
Based on the available information, there is insufficient data to provide a comprehensive answer about other indications for which NVG-291 is being trialed beyond spinal cord injury. The context does not contain specific information about:
- Additional indications for NVG-291 clinical trials
- Intervention models for these trials
- Dosing regimens for conditions other than spinal cord injury
- Administration methods in alternative therapeutic contexts
- Mechanism of action as applied to other neurological conditions
NVG-291 is a peptide mimetic that functions as a neural repair protein tyrosine phosphatase sigma (PTPσ) inhibitor, primarily investigated for spinal cord injury treatment. However, the specific details about its application to other neurological conditions are not provided in the available context.
For a complete understanding of NVG-291's broader clinical applications, additional information from clinical trial registries, scientific publications, or the developing company's pipeline reports would be necessary.
Note: As research in this area is ongoing, new indications and intervention models may have emerged since the available information was compiled.