NVG-291 Phase 1 Results and Phase 1b/2a Study Design in Individuals with Spinal Cord Injury

Research Objectives

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. A Phase 1 safety trial of NVG-291 (a receptor protein tyrosine phosphatase sigma peptide mimetic) in 70 healthy subjects supports a Phase 1b/2a efficacy/safety trial in individuals with SCI. Doses tested overlap with and exceed equivalent efficacious doses in animal models of acute/chronic SCI.

Design

The 16-week Phase 1b/2a randomized, double-blind, placebo-controlled trial (12-week treatment period, 4-week noninterventional period) will assess individuals with chronic and subacute traumatic SCI.

Setting

The trial will be conducted at a single center, Shirley Ryan AbilityLab (Chicago, IL). We will conduct longitudinal electrophysiological assessments to enable precise measurement of descending motor connectivity following treatment.

Participants

Approximately 40 subjects will be enrolled. ∼20 cervical motor incomplete SCI subjects per cohort will be enrolled: cohort 1 chronic (1 – 10 years post-injury); cohort 2 subacute (10 – 49 days post-injury). All subjects will undergo regular exercise.

Interventions

Randomization (1:1) to NVG-291 or placebo (daily subcutaneous injection) for 12 weeks.

Main Outcome Measures

The primary objective is to evaluate the change in motor evoked potential amplitudes (an index of corticospinal excitability) in predefined muscle groups. Other electrophysiological measures will also be assessed. Key clinical outcome measures include 10mWT, 9-HPT, GRASSP, pinch dynamometry, and motor scores.

Results

NVG-291 was safe and well tolerated in the Phase 1 trial and showed good pharmacokinetic characteristics. The most common AE was injection site related, more common in the NVG-291 group.

Conclusions

Phase 1 results support advancing investigation of NVG-291 to individuals with SCI. The Phase 1b/2a trial in SCI, which initiates in mid-2023, will assess change in electrophysiological and clinical measures following treatment of individuals with subacute or chronic SCI.

Author(s) Disclosures

DDM,JT,SM,MD,NC: employees and shareholders of NervGen Pharma JG,MAP: No relevant disclosures.