Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NVG-291 · 3 trials · 4 indications
Change from baseline to Week 12 in the combined GRASSP QtP score. The combined GRASSP QtP score is the sum of four Prehension Performance task scores for the right and the left hand and ranges from 0 to 40. A higher score on GRASSP QtP indicates improved prehension performance.
MEP amplitudes (corticospinal contribution) in key target muscle groups
number and frequency of adverse events
| Arm | Type | Description |
|---|---|---|
| NVG-291 Arm | EXPERIMENTAL | Participants will receive NVG-291 administered once daily by subcutaneous injection for 12 weeks during the double-blind treatment period. Randomization will occur in a 1:1 ratio and will be stratified by country (United States or Canada) and baseline American Spinal Injury Association (ASIA) Impairment Scale category (C or D). |
| Placebo Arm | PLACEBO_COMPARATOR | Participants will receive placebo administered once daily by subcutaneous injection for 12 weeks during the double-blind treatment period. Randomization will occur in a 1:1 ratio and will be stratified by country (United States or Canada) and baseline American Spinal Injury Association (ASIA) Impairment Scale category (C or D). |
| 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 | NVG-291 is an investigational peptide therapeutic administered by subcutaneous injection. Participants randomized to the experimental arm will receive NVG-291 once daily for 12 weeks. NVG-291 is designed to promote nervous system repair and functional recovery following chronic spinal cord injury. |
| Placebo | DRUG | Matching placebo is supplied as a sterile lyophilized formulation matching NVG-291 in appearance and route of administration. Participants randomized to the placebo arm will receive placebo once daily by subcutaneous injection for 12 weeks. |
Inclusion Criteria: 1. Provide written informed consent prior to any study-specific procedures. 2. Be 18 to 75 years of age, inclusive. 3. Have chronic cervical spinal cord injury resulting from acute traumatic injury occurring 1 to 10 years prior to randomization. 4. Have motor-incomplete cervical...
NVG-291 is an investigational small molecule being developed for the treatment of chronic spinal cord injury. It is currently in Phase 3 clinical development for this indication. The drug is designed to target the PTPσ receptor, which is involved in inhibiting nerve regeneration.
NVG-291 targets PTPσ, a receptor that inhibits nerve regeneration following spinal cord injury. By modulating this target, the drug aims to promote neural repair and functional recovery in patients with chronic spinal cord injury.
NVG-291 is being developed by NervGen Pharma Corp., a biopharmaceutical company listed on the stock exchange under the ticker symbol NGEN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in spinal cord injury patients.
NVG-291 is currently in Phase 3 clinical development for chronic spinal cord injury. It has received Fast Track and Orphan Drug designations from the FDA. The drug is investigational and has not yet been approved for commercial use.
NVG-291 is being evaluated in a Phase 3 trial (NCT07799532) for chronic spinal cord injury, which is not yet recruiting and plans to enroll 150 participants in the United States and Canada. Two Phase 1 trials have been completed: NCT05965700 in spinal cord injury subjects and NCT05308953 in healthy adults.
NVG-291 is the sole name provided for this investigational drug. No alternative names or aliases have been reported for this compound in the available clinical trial information.