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Dignify Therapeutics Cleared for Human Trials of Bowel Control Drug

Dignify Therapeutics Cleared for Human Trials of Bowel Control Drug

With FDA approval for its Investigational New Drug application, Research Triangle Park-based Dignify Therapeutics is moving its lead candidate, DTI-117, into human testing. The company aims to provide an on-demand, pharmacological solution for neurogenic bowel dysfunction, targeting a November 2026 start for initial volunteer dosing.

DTI-117, a short-acting peptide and neurokinin-2 receptor agonist, seeks to address the limitations of current treatments such as laxatives or manual evacuation, which are often invasive and unpredictable. The upcoming Phase 1 study, funded by the National Institutes of Health, will employ a randomized, double-blind, placebo-controlled design to assess safety, tolerability, and pharmacokinetics in healthy volunteers. Preliminary results from these cohorts are expected in early 2027.

Chief Scientific Officer Karl Thor noted that the drug's design prioritizes predictable timing and efficiency, reflecting feedback from individuals with spinal cord injuries. By moving into the clinic, Dignify transitions from its preclinical phase, bolstered by over $20 million in NIH funding. The company’s leadership views this milestone as a shift toward offering patients greater autonomy over bowel care through a therapy that induces evacuation within minutes.

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