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 SC Injection | EXPERIMENTAL | NVG-291 administered by subcutaneous injection once daily for 12 weeks, with cetirizine pretreatment. |
| Placebo for SC Injection | PLACEBO_COMPARATOR | Matching placebo administered by subcutaneous injection once daily for 12 weeks, with cetirizine pretreatment. |
| 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. |
| Placebo Injection | DRUG | A once daily injection |
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 being developed for the treatment of chronic spinal cord injury. It is an investigational small molecule therapy designed to support repair and recovery after spinal cord damage. NervGen Pharma Corp. is studying it in adults with chronic spinal cord injury, a condition with limited treatment options currently available.
NVG-291 targets PTP sigma, also written PTPσ, a receptor that inhibits nerve repair after injury. By blocking PTPσ, NVG-291 is designed to reduce the inhibitory signaling that limits axonal regeneration and functional recovery following spinal cord damage. This mechanism is the basis for its development in spinal cord injury.
NVG-291 is being developed by NervGen Pharma Corp., which trades under the ticker NGEN. The company is advancing the drug as its lead program in neurology, focused on chronic spinal cord injury. NVG-291 has received both Fast Track and Orphan Drug designations from the FDA.
NVG-291 is in Phase 3 clinical development. The pivotal trial is a randomized, double-blind, placebo-controlled study in adults with chronic spinal cord injury. NVG-291 is investigational and has not been approved by the FDA. Earlier Phase 1 studies of NVG-291 have been completed.
NVG-291 is being evaluated in the Phase 3 trial NCT07799532, titled A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury. That study is recruiting 150 participants across the United States and Canada. Two completed Phase 1 studies, NCT05965700 and NCT05308953, enrolled 24 and 74 participants respectively.
No, NVG-291 is not approved by the FDA. It remains an investigational drug in clinical development, currently in Phase 3 testing for chronic spinal cord injury. The FDA has granted NVG-291 Fast Track and Orphan Drug designations, which are intended to support and expedite the development and review process for therapies addressing serious conditions.