DTI-117 induced defecation within minutes of intramuscular injection in conscious minipigs, with responder rates rising with dose, and confirmed in a crossover study
Pharmacokinetic profile of rapid absorption and fast clearance, with a mean terminal half-life of approximately 3 to 4 minutes, is consistent with a short-acting effect
DTI-117 is being evaluated in a NIH-funded randomized, double-blind, placebo-controlled Phase 1 single-ascending-dose study
RESEARCH TRIANGLE PARK, N.C. – October 13, 2026 – Dignify Therapeutics (“Dignify”, the “Company”), a biopharmaceutical development company focused on restoring bowel and bladder control for people with neurological conditions, today announced preclinical safety, efficacy and pharmacokinetic (PK) data for DTI-117 in a poster presented on October 11, 2026, at the American College of Gastroenterology (ACG) 2026 Annual Scientific Meeting in Nashville, Tennessee. DTI-117 is being developed as an on-demand therapy to restore controlled evacuation in people with neurogenic bowel dysfunction (NBD).
Eight conscious minipigs (four male, four female) received intramuscular (IM) injections of DTI-117 or vehicle and were observed for defecation, urination and side effects. The study included a dose-range-finding phase (single doses of 0.01 to 3 mg/kg), a 12-day crossover phase (0.03 and 0.3 mg/kg) and a PK phase (0.1 and 1.0 mg/kg).
- Defecation responder rates increased with dose in the dose-range-finding phase, with doses above 0.03 mg/kg, producing rates significantly different from vehicle.
- In the crossover phase, both 0.03 and 0.3 mg/kg produced defecation responder rates significantly different from vehicle (p < 0.05).
- Higher doses triggered multiple defecation events within 15 minutes of a single injection.
- Urination was also induced, with dose-dependent responder rates. Latencies for both urination and defecation did not differ significantly across doses by one-way ANOVA (p > 0.05).
- Side effects (diarrhea, emesis, lethargy and flushing) occurred at higher doses and were transient.
- After IM dosing, plasma concentrations showed rapid absorption and fast clearance. Median time to peak concentration was 1.0 minute at 0.1 mg/kg (range 1-3) and 2.0 minutes at 1.0 mg/kg. Mean peak concentration was 64.0 ng/mL and 560 ng/mL, respectively. Mean terminal half-life was 2.65 minutes at 0.1 mg/kg and 3.59 minutes at 1.0 mg/kg.
- The study demonstrated NK2 receptor agonists may provide a predictable, convenient on-demand defecation therapy for constipation that is resistant to current therapies, such as refractory constipation and neurogenic bowel disease.
DTI-117 is moving into the clinic following FDA clearance of its Investigational New Drug application, announced October 7, 2026. A randomized, double-blind, placebo-controlled, single-ascending-dose Phase 1 study in healthy volunteers, funded by the National Institutes of Health, is expected to begin dosing in November 2026.
“For an on-demand therapy, what matters is a response that begins within minutes and exposure that clears just as quickly. In these studies, the pharmacokinetic profile tracked the effect we observed, which is the relationship we hoped to see as we bring DTI-117 into the clinic as the potential first drug to treat constipation due to defecation dysfunction,” said Karl Thor, Ph.D., Chief Scientific Officer of Dignify Therapeutics.
“The preclinical data we presented at ACG are part of the foundation that supported FDA clearance of our IND for DTI-117, and we are pleased to share them with the gastroenterology community,” said Anthony DiTonno, Chief Executive Officer of Dignify Therapeutics. “These findings reinforce our work to give people with neurogenic bowel dysfunction, and the caregivers who support them, a more reliable way to plan bowel care. We are preparing to begin the Phase 1 study in November as we continue advancing DTI-117 toward patients.”
Poster Presentation Details
Title: Preclinical Safety, Efficacy, and PK of DTI-117, an NK2 Receptor Peptide Agonist, in Minipigs: A Proposed “Rapid-onset, Short-duration, On-Demand Defecation” Treatment for Constipation Due to Dysfunctional Defecation
Session and Time: P0808, Scientific Poster Session, Sunday October 11, 2026; 3:30-6:45 PM
Presented by: Karl B. Thor, PhD
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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. With the FDA clearance of the IND application, the NIH-funded randomized, double-blind, placebo-controlled Phase 1 single-ascending-dose study evaluating DTI-117 in healthy volunteers is expected to begin dosing healthy volunteers in November 2026.
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.
Media and Investor Contact
Anthony DiTonno
Chief Executive Officer
ditonno@dignifytherapeutics.com
Stephanie Carrington
ICR Healthcare
Stephanie.carrington@icrhealthcare.com
