Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NVG-291 · 2 trials · 4 indications
MEP amplitudes (corticospinal contribution) in key target muscle groups
number and frequency of adverse events
| Arm | Type | Description |
|---|---|---|
| NVG-291 for Injection | EXPERIMENTAL | Injected under the skin (subcutaneous). |
| Placebo | PLACEBO_COMPARATOR | Injected under the skin (subcutaneous). |
| NVG-291 SAD | EXPERIMENTAL | Doses will begin at the lowest dose level in Cohort 1, increasing in dose with each subsequent cohort to the highest dose level in Cohort 6 or until a maximum tolerated dose (MTD) is reached. |
| NVG-291 MAD | EXPERIMENTAL | Participants will receive 1 dose daily for for 14 consecutive days. The maximum starting dose for MAD will be 2 dose levels lower than the maximum dose achieved during SAD. There will be a maximum of 3 dosing cohorts in Part 2. The maximum daily dose in Part 2 will not exceed the maximum daily dose tolerated in Part 1. |
| NVG-291 MAD - Males and Premenopausal Females | EXPERIMENTAL | Participants will receive 1 dose daily for for 14 consecutive days. The dose maximum daily dose in Part 3 will not exceed the maximum daily dose tolerated in either Part 1 or 2. |
| Name | Type | Description |
|---|---|---|
| NVG-291 | DRUG | A once daily injection |
| Placebo | OTHER | Salt water is being used as a placebo and will be injected under the skin (subcutaneous). |
Inclusion Criteria: A subject must provide written informed consent in accordance with local regulations prior to initiation of any study-specific activities/procedures. A legally authorized representative (LAR) may be used to assist in signing the informed consent. Cervical SCI resulting from acu...
NVG-291 is an investigational small molecule being developed for spinal cord injury. It is being studied in patients with chronic and subacute spinal cord injuries. The drug is currently in Phase 1 clinical development and has not been approved by the FDA.
NVG-291 is being developed by NervGen Pharma Corp., a biopharmaceutical company. The company's stock is listed under the ticker symbol NGEN. NervGen is conducting clinical trials to evaluate the safety and efficacy of NVG-291 in spinal cord injury.
NVG-291 is in Phase 1 clinical development. It has completed two Phase 1 trials, one in healthy adults and one in subjects with spinal cord injury. The drug has received Fast Track and Orphan Drug designations from the FDA, but it is not yet approved.
NVG-291 has been studied in two completed Phase 1 trials. NCT05308953 was a safety study in 74 healthy adults in Australia. NCT05965700 evaluated NVG-291 in 24 subjects with spinal cord injuries in the United States. Both trials are now completed.
NVG-291 is not FDA approved. It is an investigational drug currently in Phase 1 clinical trials. The FDA has granted NVG-291 Fast Track and Orphan Drug designations for spinal cord injury, which are intended to expedite development and review, but approval has not been granted.
NVG-291 is a distinct investigational small molecule developed by NervGen Pharma Corp. It is not known to be the same as any other approved drug. Its mechanism of action is not publicly detailed in the available information, and it is being studied specifically for spinal cord injury.