Dignify Therapeutics has secured investigational new drug (IND) clearance from the US Food and Drug Administration (FDA) to advance DTI-117 into a Phase I trial for neurogenic bowel dysfunction (NBD).
The drug candidate is being developed as an on-demand treatment to help restore controlled bowel evacuation.
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The regulatory clearance marks the progression of the US biopharmaceutical firm from the preclinical phase to clinical-stage development.
Dignify Therapeutics plans to administer the first dose to a healthy volunteer in November 2026, with initial topline findings from the first cohorts expected in early 2027.
The double-blind, randomised, single-ascending-dose, placebo-controlled study will assess the tolerability, safety, and pharmacokinetics of single intramuscular doses of DTI-117 in healthy patients.
The therapy is a short-acting peptide and neurokinin-2 receptor agonist engineered to trigger bowel evacuation within minutes, offering patients greater command over the timing and setting of defecation.
Dignify Therapeutics reported that DTI-117 demonstrated rapid and controlled bowel and bladder emptying across multiple animal models during preclinical testing.
Dignify Therapeutics chief scientific officer Karl Thor said: “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.
“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.”
The study received funding from the National Institutes of Health (NIH), with development backed by the National Institute of Neurological Disorders and Stroke under award number U44NS129628.
Dignify Therapeutics, situated at the First Flight Venture Center in Research Triangle Park, North Carolina, focuses on therapies for bowel and bladder voiding dysfunction in neurological patients.
Beside support from founders and venture capital firms, the company has received backing from the North Carolina Biotechnology Center and the One NC Small Business Program, alongside 18 NIH awards totalling over $20m.
