# Preclinical characterization of a novel neuropeptide for inducing "on-demand" voiding

> **NIH NIH U44** · DIGNIFY THERAPEUTICS, LLC · 2020 · $1,823,630

## Abstract

PROJECT SUMMARY (ABSTRACT)
Spinal cord injury (SCI) affects an estimated 285,000 Americans. Damage to nerves in the spinal cord can
result in a loss of voluntary control over bladder and bowel function that often produces both incontinence and
retention of urine and stools in the same patient. The standard of care for urine retention is bladder
catheterization to void urine, which may produce urinary tract infections (UTIs) and hospitalization. Retention of
feces requires manual extraction bowel programs, which are extremely time consuming, can contribute to
UTIs, and are stigmatizing for patients and caregivers. Because bladder and bowel dysfunction are among the
top concerns of people with SCI, a convenient and safe “on-demand, rapid-onset, short-duration, drug-induced,
voiding therapy” would be a life-changing paradigm shift in treating bladder and bowel dysfunction for those
who currently rely on life-long multiple daily catheterizations and daily digital bowel programs.
Dignify Therapeutics is developing next-generation potent and selective neurokinin 2 receptor (NK2R) agonists
to produce “on-demand” voiding in people with SCI. In a series of proof-of-concept studies, the prototype
NK2R agonist, DTI-100, rapidly induced bladder and bowel voiding in multiple animal models. A next-
generation NK2R agonist, DTI-117, has been identified that has optimized selectivity and, potentially, an
improved pharmacokinetic (PK) profile for subcutaneous administration. Like DTI-100, DTI-117 exhibits
properties that support a target product profile of rapid-onset, short-duration, drug-induced voiding. In addition,
due to its greater target selectivity, DTI-117 potentially has a greater therapeutic index than DTI-100.
Dignify is now advancing DTI-117 through preclinical development as its lead NK2R agonist. This Fast-Track
CREATE Bio Optimization Track U44 application is focused on extensive preclinical characterization of DTI-
117 for subsequent IND-enabling studies and future support from the CREATE Bio Development program.
Phase I activities will establish successful synthesis, stability, and bioanalytical measurement of DTI-117, and
determine the therapeutic index (TI) for DTI-117 in dog. Phase II activities will complete preclinical
characterization of DTI-117 and provide additional toxicity and safety assessments prior to the initiation of IND-
enabling studies.
The proposed project will allow Dignify Therapeutics to develop an optimized “on-demand, rapid-onset, short-
duration, drug-induced, voiding therapy” to treat bladder and bowel dysfunction in people with SCI. This
therapy would greatly improve quality of life for people with SCI, reduce UTIs and associated health risks, and
decrease overall healthcare costs.

## Key facts

- **NIH application ID:** 10080913
- **Project number:** 4U44NS106685-02
- **Recipient organization:** DIGNIFY THERAPEUTICS, LLC
- **Principal Investigator:** Edward Burgard
- **Activity code:** U44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,823,630
- **Award type:** 4N
- **Project period:** 2019-02-01 → 2022-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10080913

## Citation

> US National Institutes of Health, RePORTER application 10080913, Preclinical characterization of a novel neuropeptide for inducing "on-demand" voiding (4U44NS106685-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10080913. Licensed CC0.

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