NVG-291 for Spinal Cord Injury

Overseen By Tom Feinberg

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: NervGen Pharma

Must not be taking: Opioids, 4-aminopyridine

Disqualifiers: Nontraumatic SCI, Seizures, Substance abuse, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called NVG-291 for individuals with spinal cord injuries. The goal is to determine if NVG-291 can improve movement and function in those who suffered a spinal cord injury from physical trauma. Participants will receive either the NVG-291 injection or a placebo (a harmless substance) to compare effects. Ideal candidates for this trial have an incomplete spinal cord injury in the neck area (C7 or higher) and can take at least one step with one leg without support. As a Phase 1 trial, this research focuses on understanding how NVG-291 works in people, offering participants the chance to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial protocol does not clearly specify if you must stop taking your current medications. However, you cannot participate if you have taken certain medications recently, like 4-aminopyridine within 14 days or any non-permitted medication within 5.5 half-lives or 7 days before randomization.

Is there any evidence suggesting that NVG-291 is likely to be safe for humans?

Research has shown that NVG-291 has undergone safety testing in both healthy adults and individuals with spinal cord injuries. In these studies, participants tolerated NVG-291 well, and no major safety issues were reported. The trials included assessments such as physical exams, vital signs, and heart activity (ECG) to ensure participant safety. As this treatment remains in the early stages of clinical testing, researchers continue to gather detailed safety information. However, results so far suggest that NVG-291 might be safe for humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for spinal cord injury?

NVG-291 is unique because it targets the repair of damaged nerve cells, potentially allowing for improved recovery after a spinal cord injury. Unlike standard treatments that primarily focus on managing symptoms or preventing further damage, NVG-291 works by promoting the body's intrinsic ability to repair itself, which could lead to significant functional improvements. Researchers are excited about its novel mechanism of action, as it represents a promising shift towards regenerative medicine for spinal cord injuries.

What evidence suggests that NVG-291 might be an effective treatment for spinal cord injury?

Research shows that NVG-291, which participants in this trial may receive, may help repair the nervous system after spinal cord injuries. Studies have found that NVG-291 can enhance movement ability following an injury. This improvement results from stronger signals from the brain to the muscles. The treatment aids in healing nerve cells and their connections. Early findings suggest that NVG-291 could be a breakthrough in treating spinal cord injuries by enhancing the body's natural healing process. ^{1 3 4 6 7}

Who Is on the Research Team?

Daniel Mikol, M.D. Ph.D.

Principal Investigator

NervGen Pharma

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with incomplete cervical spinal cord injury from physical trauma, able to take at least one step and have some hand grasp ability. They must be fluent in English, willing to follow the study plan, and not involved in another clinical trial or have certain medical conditions like severe pain, high BMI, or recent substance abuse.

Inclusion Criteria

Must be fluent in English.

My spinal cord injury in the neck was caused by a sudden injury.

I have given or will give my written consent to participate.

Exclusion Criteria

Any implanted internal spinal cord stimulator.

I use opioids through spinal injection.

I have taken 4-aminopyridine in the last 14 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NVG-291 or placebo injections subcutaneously to evaluate safety, tolerability, and effects on descending connectivity in spinal cord injury subjects

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including incidences of treatment emergent adverse events

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NVG-291

Trial Overview The study tests NVG-291 on people with spinal cord injuries. It's a randomized (people are put into groups by chance), double-blind (neither participants nor researchers know who gets what treatment), placebo-controlled (compared against an inactive substance) trial at Shirley Ryan AbilityLab.

How Is the Trial Designed?

Group I: NVG-291 for Injection Experimental Treatment 1 Intervention

Injected under the skin (subcutaneous).

Group II: Placebo Placebo Group 1 Intervention

Injected under the skin (subcutaneous).

Who Is Running the Clinical Trial?

NervGen Pharma

Lead Sponsor

Trials

2

Recruited

110+

Published Research Related to This Trial

In a study of 2807 patients with nontraumatic spinal cord injuries (NTSCI), the most common injury type was incomplete cervical level injury, with a significant number of patients experiencing hospital-acquired complications, particularly falls.

Factors such as older age, higher comorbidity index, and ICU stays were linked to poorer outcomes, including increased odds of non-home discharge and higher in-hospital mortality, highlighting the need for careful management of these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical characteristics, hospital course, and disposition of patients with nontraumatic spinal cord injury in a large private health care system in the United States. Lee, SW., Werner, B., Holt, J., et al.[2023]

The average length of stay in acute rehabilitation for patients with traumatic spinal cord injury decreased from 74 days to 60 days between 1990 and 1997, indicating improvements in rehabilitation efficiency.

However, there was an increase in discharges to nursing homes and rehospitalizations during the same period, suggesting that while rehabilitation may be quicker, some patients still face significant challenges in their recovery and reintegration into the community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical rehabilitation length of stay and outcomes for persons with traumatic spinal cord injury--1990-1997. Eastwood, EA., Hagglund, KJ., Ragnarsson, KT., et al.[2022]

The North American Clinical Trials Network (NACTN) has collected high-quality data from over 1000 patients with traumatic spinal cord injury (SCI), enhancing our understanding of SCI management and outcomes.

In a Phase III study of Riluzole involving 192 patients, while the primary efficacy endpoint was not met, significant functional recovery was observed in cervical SCI patients, suggesting potential benefits of Riluzole in specific subgroups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Introduction to the North American Clinical Trials Network for Spinal Cord Injury Special Edition: Reflections on Accomplishments and a Look to the Future. Fehlings, MG., Neal, CJ., Hejrati, N., et al.[2023]

The North American Clinical Trials Network (NACTN) has successfully organized a consortium of 10 neurosurgery departments to conduct clinical trials focused on spinal cord injury (SCI), ensuring patient safety and meaningful data outcomes.

NACTN has enrolled 485 patients in a database tracking recovery after SCI and completed the enrollment of 36 patients in its first Phase I clinical trial testing the neuroprotective drug riluzole, which includes pharmacokinetic and pharmacodynamic studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

North American Clinical Trials Network for the Treatment of Spinal Cord Injury: goals and progress. Grossman, RG., Toups, EG., Frankowski, RF., et al.[2013]

The PTEN inhibitor bisperoxovanadium (bpV) significantly reduces cell death in spinal cord injury models, demonstrating its potential for neuroprotection and functional recovery, as shown in both in vitro and in vivo studies.

bpV activates the PI3K/Akt signaling pathway, which is crucial for neuronal survival, and its effects can be blocked by specific inhibitors, indicating a targeted mechanism of action in promoting cell survival after spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bisperoxovanadium Mediates Neuronal Protection through Inhibition of PTEN and Activation of PI3K/AKT-mTOR Signaling after Traumatic Spinal Injuries. Walker, CL., Wu, X., Liu, NK., et al.[2021]

Citations

1. nervgen.com nervgen.com/nervgen-pharma-reports-positive-topline-data-from-the-chronic-cohort-of-its-phase-1b-2a-clinical-trial-evaluating-nvg-291-in-spinal-cord-injury/

NervGen Pharma Reports Positive Topline Data from the ... Topline results from the trial support the potential of NVG-291 to promote nervous system repair. The trial met a co-primary endpoint ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05965700

NCT05965700 | NVG-291 in Spinal Cord Injury Subjects To evaluate the effect of NVG-291 on descending connectivity in subjects with subacute and chronic SCI (20 subjects per Cohort and results will be analyzed ...

3. nervgen.com nervgen.com/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 to Present Topline Data for NVG-291 ... These studies implicated several potential molecular and cellular mechanisms by which NVG-291-R promotes neurorepair and functional improvement ...

4. neurologylive.com neurologylive.com/view/insights-nervgen-pharma-positive-phase-1b-2a-data-nvg-291-spinal-cord-injury

Insights on NervGen Pharma's Positive Phase 1b/2a Data ... NVG-291 is the first pharmaceutical candidate to show improved motor recovery based on increased motor evoked potential amplitude. These study ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003999324001436

NVG-291 Phase 1 Results and Phase 1b/2a Study Design ... To provide an update on the development of NVG-291 for spinal cord injury (SCI). There is a high unmet need for treatments to repair damage after SCI.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05308953?cond=NVG-291&rank=2

A Phase I Safety Study of NVG-291 in Healthy Adults This is a randomized, triple-blind (subjects, Investigators, and Sponsor blinded), placebo-controlled Single Ascending Dose (SAD) and Multiple Ascending Dose ( ...

7. case.edu case.edu/research/sites/default/files/2024-02/NGEN%20NR%20-%20AAN%20Presentation%20Mar%2031%202022%20Final.pdf

nervgen presenting interim phase 1 clinical trial data for ... NVG-291 has shown efficacy in a range of animal models, including models of nervous system trauma such as spinal cord injury and peripheral nerve injury, and ...