# Clinical Evaluation of NoGo Trap Therapy in Chronic SCI

> **NIH NIH R44** · RENETX BIO, INC. · 2020 · $1,545,547

## Abstract

Summary
Approximately 300,000 patients suffer from persistent neurological impairment due to chronic spinal cord injury
(SCI) in the United States. Currently, there are no FDA-approved drugs to promote neurologic recovery in
patients suffering from the life-long, profound impairments due to chronic SCI. An effective neurorestorative
therapy would significantly improve the ability of patients to conduct activities of daily living and reduce the
burdens for patients, families, and caregivers. Direct and indirect costs associated with care would also be
significantly reduced if a successful therapy were developed.
The NoGo Trap, a soluble decoy receptor protein comprised of the extracellular domain of NgR1 and IgG Fc,
has been shown effective in promoting axon growth and recovery of function in multiple models of CNS injury.
These preclinical studies encompassed several different models of SCI including chronic contusion SCI.
Recently, the human form of the protein known as AXER-204 has been found to promote corticospinal axon
growth and recovery of use of impaired limbs in a monkey model of cervical SCI. IND-enabling development
has been completed with NINDS grant support and through NIH’s Bridging Interventional Development Gaps
program (BrIDGs) and a Phase 1b clinical trial has been initiated in participants with chronic cervical SCI to
determine the safety, tolerability, and pharmacokinetics of single-ascending doses of AXER-204.
ReNetX proposes to initiate a repeat-dose Phase 2a clinical trial following completion of the ongoing Phase 1b
single-ascending dose study. This repeat-dose, double-blinded, placebo-controlled trial will evaluate the
safety, tolerability, and pharmacokinetics of repeat doses of AXER-204. In addition, the trial is designed to
evaluate efficacy in promoting recovery of upper limb function. A number of secondary and exploratory
endpoints will be evaluated to further assess effects on motor, sensory, and autonomic function. Successful
completion of the planned trial will determine if AXER-204 represents a promising therapy for further clinical
development as a therapy for chronic SCI. In addition, the data from the trial will help address the paucity of
high-quality data in patients with chronic SCI patients and serve to advance SCI clinical research.

## Key facts

- **NIH application ID:** 10076519
- **Project number:** 1R44NS118974-01
- **Recipient organization:** RENETX BIO, INC.
- **Principal Investigator:** Erika Smith
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,545,547
- **Award type:** 1
- **Project period:** 2020-09-15 → 2022-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10076519

## Citation

> US National Institutes of Health, RePORTER application 10076519, Clinical Evaluation of NoGo Trap Therapy in Chronic SCI (1R44NS118974-01). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10076519. Licensed CC0.

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