# Preparing for IND-enabling safety studies for a potent and efficient neuroprotective drug.

> **NIH NIH R43** · NEUREXIS THERAPEUTICS, INC. · 2021 · $496,145

## Abstract

Project Summary/Abstract
The Ca2+/calmodulin-dependent protein kinase II (CaMKII) is a central mediator of two opposing forms of NMDA-
receptor (NMDAR)-dependent synaptic plasticity: long-term potentiation (LTP) and depression (LTD).
Pathological overstimulation of NMDARs during cerebral ischemia causes excitotoxic neuronal cell death, and
we have recently shown that CaMKII also mediates the neuronal damage after global cerebral ischemia (GCI).
Importantly, in vivo injection of our optimized CaMKII inhibitor (tatCN19o) provided significant neuroprotection
after GCI in models that closely mimic the most relevant human conditions: cardiopulmonary resuscitation (CPR)
after cardiac arrest in mice or after ventricular fibrillations in pig (unpublished). CaMKII inhibition (i) was
conducted at a highly clinically relevant timepoint for these conditions (30 min after CPR); (ii) was effective in
conjunction with current standard of care (therapeutic hypothermia); and (iii) protected not only from neuronal
cell death, but also from the long-lasting functional impairments in LTP that are seen in the surviving neurons.
In order to enable testing in humans, this SBIR project will conduct the studies required for a successful IND-
application with the FDA, specifically including complete toxicology and safety pharmacology. In this phase I
proposal, we will first complete the final therapeutically relevant piece of biochemical characterization of the
inhibitor. Then, we will initiate the PK studies that are required for an IND application (which first requires a
validation of a method for detection of our inhibitor in serum of the tested species).

## Key facts

- **NIH application ID:** 10257462
- **Project number:** 1R43NS120427-01A1
- **Recipient organization:** NEUREXIS THERAPEUTICS, INC.
- **Principal Investigator:** Robyn L Goforth
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $496,145
- **Award type:** 1
- **Project period:** 2021-09-24 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10257462

## Citation

> US National Institutes of Health, RePORTER application 10257462, Preparing for IND-enabling safety studies for a potent and efficient neuroprotective drug. (1R43NS120427-01A1). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/10257462. Licensed CC0.

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