# Neupron™: A Neuroprotective Agent for Treating Acute Spinal Cord Injury

> **NIH NIH R41** · AXONEURAL THERAPEUTICS, INC. · 2021 · $399,987

## Abstract

Project Description: The pathophysiology of traumatic spinal cord injury (SCI) involves the initial physical
impact, which leads to secondary injury cascades of degenerative cellular and molecular events. The
secondary injury spreads along the spinal cord over time, which adds new levels of disability and has
devastating effects. Excess reactive oxygen species (ROS) formation at the impact site is an important
component of these secondary injury cascades. Neupron™ is patented polymeric nanoparticle composition
encapsulating antioxidant enzymes, superoxide dismutase and catalase, with high catalytic activity to
neutralize ROS. The preliminary data demonstrated efficacy of Neupron following intravenous injection at 3 hrs
after the injury in a rat contusion model of SCI. The treatment neutralized the excess ROS formed after the
injury, significantly inhibited the progression of secondary injury, and regained locomotive functions.
AxoNeural Therapeutics, Inc., is a new spin off company of Cleveland Clinic Innovation. The goal is to develop
Neupron as an early therapeutic intervention to protect the spinal cord from secondary injury and promote
regeneration. Such an effective early intervention can minimize severity of the post-injury disability and
enhances the prospects of achieving better neurological and functional recovery. Through the R41 STTR
Phase I grant, the main objective is to undertake critical formulation development of Neupron. The successful
outcome of Phase-I would set the stage for Phase-II application to advance Neupron to the IND stage and
ultimately to clinical development. Since there are ~17,000 cases of SCI per year in the US, Neupron will be
considered as an orphan drug. Our aims for this proposal are:
Aim 1: Establish parameters for pilot-scale production of Neupron: a) Establish a scale-up process
that is reproducible for production of Neupron under GLP conditions and b) Evaluate Neupron for initial
assessment of its biocompatibility in rat SCI model. Milestones: At least three consecutive production batches
showing less than 5% variation in physical and biological (catalytic) characteristics of Neupron and without any
toxicity concern.
 Aim 2: Characterize Neupron produced under cGMP conditions: Nebraska Nanomedicine Production
Plant is a contract laboratory with cGMP nanoparticle production capacity. Neupron prepared under cGMP
condition will be tested for physical and biological properties to ensure successful transfer of the protocol
developed under GLP conditions. Neupron will be evaluated for bioburden and endotoxin levels. Milestones:
Neupron meets the FDA guidelines for parenteral products (2l CFR parts 210 and 211). Arrange Pre-IND
meeting with the FDA.

## Key facts

- **NIH application ID:** 10255000
- **Project number:** 1R41NS122587-01
- **Recipient organization:** AXONEURAL THERAPEUTICS, INC.
- **Principal Investigator:** VINOD D LABHASETWAR
- **Activity code:** R41 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $399,987
- **Award type:** 1
- **Project period:** 2021-06-01 → 2023-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10255000

## Citation

> US National Institutes of Health, RePORTER application 10255000, Neupron™: A Neuroprotective Agent for Treating Acute Spinal Cord Injury (1R41NS122587-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10255000. Licensed CC0.

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