# SDF-1 mRNA gene therapy for restoration of erectile function

> **NIH NIH R43** · EVINCIS BIO, INC. · 2021 · $314,913

## Abstract

Abstract
Erectile dysfunction (ED) affects about 18 million men in the U.S. and is estimated to affect 322 million men
worldwide by 2025. ED can have a profound negative impact on quality of life and well-being and is often
associated with anxiety and depression. ED also represents a significant economic burden, with over $4 billion
spent in 2017 in the U.S. ED is a common consequence of diseases that affect the microvasculature and nervous
tissue, including common chronic diseases such as hypertension, dyslipidemia, and diabetes, and a frequent
side effect of prostate cancer treatment. Currently available ED treatments are moderately effective at best, have
high discontinuation rates, and address only the symptoms, not the underlying causes. To address the need
for novel treatments for ED, Evincis Bio is developing a regenerative gene therapy based on stromal
cell‐derived factor‐1 (SDF-1) mRNA. SDF-1 is a highly conserved chemokine that regulates an endogenous
repair pathway used by many tissues throughout the body, such as the heart, brain, muscle, and vasculature.
Often upregulated following injury, SDF-1 signaling leads to stem cell migration to the injury site. SDF-1 binds to
its receptor CXCR4 on resident tissues, including nerves, muscle, and vasculature, inducing angiogenesis,
neurogenesis, anti-apoptotic pathways, and upregulating the expression of growth factors. Evincis has
demonstrated that SDF-1 penile injections improve erectile function in a rat model of ED. This
improvement was associated with increased major pelvic ganglion (MPG) neurons, decreased penile fibrosis,
and increased growth factor expression in penile tissues. SDF-1 penile injections were shown to upregulate the
expression of stem cell-associated genes in the MPG and erectile tissue. Evincis has also demonstrated the
feasibility of targeted mRNA-based gene expression in penile tissues. In fact, mRNA technology is being
utilized by several current COVID-19 vaccines. In this Phase I project, Evincis will conduct in vitro and in vivo
dosing, efficacy, and safety studies to support further clinical research. This will be accomplished through the
following specific aims: 1) Screen engineered mRNA candidates in vitro for expression efficiency and cytotoxicity;
2) Determine EVI-200 dosage, expression duration, and safety in vivo; and 3) Perform efficacy and cancer safety
studies in vivo. These studies will support further Phase II work, in which Evincis will expand the preclinical
testing to additional disease states, investigate different nucleic acid carriers, perform pharmacokinetic and
toxicology studies, and initiate the GMP setup necessary to support an IND application and start a Phase I clinical
trial. Evincis will pursue approval as a biologic, resulting in a product J-code and stand-alone reimbursement for
the in-office procedure. If successful, EVI-200 will be the first therapy specifically designed to treat the
underlying causes of ED due to injury of nerve, musc...

## Key facts

- **NIH application ID:** 10325466
- **Project number:** 1R43DK130750-01
- **Recipient organization:** EVINCIS BIO, INC.
- **Principal Investigator:** Nikolai Anton Sopko
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $314,913
- **Award type:** 1
- **Project period:** 2021-09-15 → 2025-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10325466

## Citation

> US National Institutes of Health, RePORTER application 10325466, SDF-1 mRNA gene therapy for restoration of erectile function (1R43DK130750-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10325466. Licensed CC0.

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