# Protein therapeutic to facilitate healing of chronic wounds.

> **NIH NIH R44** · TRIM-EDICINE, INC. · 2020 · $948,478

## Abstract

Project Summary
This proposal builds upon the advances from the SBIR-Phase I program (R43GM123887), targeting the
development of recombinant human MG53 (rhMG53), a novel tissue repair protein, as a topical therapeutic
agent to facilitate healing of chronic wounds. Wound care represents a challenging problem to the public
health, as no effective treatments for chronic non-healing wounds are available. MG53 is an essential
component of cell membrane repair that protects against tissue injuries. Research and development efforts at
TRIM-edicine, Inc. have established that rhMG53 protein has great potential in facilitation of wound healing
and reduction of scar formation. From the SBIR-Phase I program we obtained proof-of-concept data that
support our translational and commercialization effort toward developing rhMG53 as a protein therapeutic to
treat chronic wounds. We developed the protocol for scale-up production of rhMG53 and the analytical
methods for quantification and quality control of rhMG53. We obtained promising data to support the efficacy
for rhMG53 in treatment of cutaneous wounds in multiple animal models. We also conducted non-GLP
toxicological studies in rodent and dog models and found that rhMG53 as a topical cream did not cause
irritation to the skin. No-observed-adverse-effect-level with intravenous administration is >40 mg/kg in rats,
supporting the safety of rhMG53 to treat chronic wounds. In this SBIR-Phase II application, we outlined a
milestone-driven research plan with deliverable matrixes to reach the goal of filling an Investigational New Drug
(IND) application with the FDA to initiate the human clinical trials. Our understanding of MG53’s biological role
in tissue repair-regeneration support the multi-cellular function of MG53 in promoting the healing process, as
well as in mitigation of scarring associated with dermal injuries. We envision that rhMG53 has advantage over
the current paradigms to treat human chronic wounds.

## Key facts

- **NIH application ID:** 9896846
- **Project number:** 5R44GM123887-03
- **Recipient organization:** TRIM-EDICINE, INC.
- **Principal Investigator:** Tao Tan
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $948,478
- **Award type:** 5
- **Project period:** 2017-07-01 → 2021-09-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9896846

## Citation

> US National Institutes of Health, RePORTER application 9896846, Protein therapeutic to facilitate healing of chronic wounds. (5R44GM123887-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9896846. Licensed CC0.

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