NIH-funded randomized, double-blind, placebo-controlled Phase 1 single-ascending-dose study expected to begin dosing healthy volunteers in November 2026

Preliminary topline data from initial cohorts anticipated in early 2027

RESEARCH TRIANGLE PARK, N.C., Oct. 7, 2026 /PRNewswire/ -- Dignify Therapeutics ("Dignify", the "Company"), a biopharmaceutical development company focused on restoring bowel and bladder control for people with neurological conditions, today announced that its Investigational New Drug (IND) application for DTI-117 has been cleared by the U.S. Food and Drug Administration (FDA), allowing the Company to proceed with first-in-human clinical evaluation. DTI-117 is being developed as an on-demand therapy to restore controlled evacuation in people with neurogenic bowel dysfunction (NBD). The IND clearance marks Dignify's transition from preclinical development into clinical-stage development.

The Phase 1 clinical trial is a randomized, double-blind, placebo-controlled, single-ascending-dose study designed to evaluate the safety, tolerability and pharmacokinetics of single intramuscular doses of DTI-117 in healthy volunteers. The study is funded by the National Institutes of Health (NIH).

DTI-117 is a novel drug candidate designed to induce rapid, on-demand defecation within minutes and potentially give people greater control over the timing and location of evacuation. In preclinical studies, DTI-117 has demonstrated rapid, controlled bladder and bowel emptying across multiple animal models.

People with NBD can have substantial difficulty voluntarily initiating bowel movements, which can require significant time, effort, and caregiver assistance. Current approaches, including laxatives, enemas and manual evacuation, may lack predictable timing and can be invasive or stigmatizing.

"Through extensive interactions with people with spinal cord injury and personal experience with my son, who has a C2 spinal cord injury, we designed DTI-117 around the attributes that matter most for a drug-induced defecation therapy: predictable start and stop timing, brief duration, efficient emptying, and tolerability," said Karl Thor, Ph.D., Chief Scientific Officer of Dignify Therapeutics. "As a small peptide designed for short-acting exposure, we believe DTI-117 has the potential to deliver on these attributes and give people greater control over bowel care."

"FDA clearance of our IND allows us to begin evaluating DTI-117 in the clinic and represents an important milestone for Dignify," said Anthony DiTonno, Chief Executive Officer of Dignify Therapeutics. "We are on track to dose the first participant in the Phase 1 healthy volunteer trial in November and anticipate preliminary topline data from the first few cohorts in early 2027."

About DTI-117

DTI-117 is a novel, short-acting peptide and neurokinin-2 receptor agonist being developed by Dignify Therapeutics as an on-demand treatment for neurogenic bowel dysfunction and other bladder and bowel voiding disorders. DTI-117 is designed to produce rapid, transient emptying with a short duration of action suited to patient-controlled voiding.

About Dignify Therapeutics

Founded by a team of serial entrepreneurs and internationally recognized scientists, Dignify Therapeutics' mission is to provide practical and convenient treatments for bladder and bowel voiding dysfunction, especially in people with neurogenic conditions. The Company has been supported by founders, venture capital firms, the North Carolina Biotechnology Center, the One NC Small Business Program, and the National Institutes of Health. Dignify has received 18 NIH awards and more than $20 million in NIH funding. Dignify Therapeutics is located at the First Flight Venture Center in Research Triangle Park, North Carolina.

DTI-117 development is supported by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health under Award Number U44NS129628. The content of this release is solely the responsibility of Dignify Therapeutics and does not necessarily represent the official views of the National Institutes of Health.

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SOURCE Dignify Therapeutics