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Ulcerative colitis is a chronic inflammatory condition primarily affecting the colon and rectum. The primary drugs used in the treatment of ulcerative colitis are aminosalicylates. They exhibit anti-inflammatory and immunosuppressive properties. They modulate inflammatory mediators and inhibit the activity of nuclear factor κB (NF-κB). Aminosalicylates also reduce inflammation by inhibiting prostaglandin and leukotriene production and decreasing neutrophil chemotaxis and superoxide...
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Upon diagnosis, managing Inflammatory Bowel Disease (IBD) involves addressing several crucial aspects. The primary goals include resting the bowel, correcting malnutrition, and providing symptomatic relief. Resting the bowel may consist of medications to reduce inflammation and promote healing. Correcting malnutrition is essential, often requiring dietary adjustments and nutritional supplements. Symptomatic relief aims to ease pain, diarrhea, and other discomforts in IBD.
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Development of Gut-Selective Pan-Janus Kinase Inhibitor TD-1473 for Ulcerative Colitis: A Translational Medicine

William J Sandborn1, Deanna D Nguyen2, David T Beattie2

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|March 13, 2020
PubMed
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A new gut-selective pan-Janus kinase inhibitor, TD-1473, shows promise for ulcerative colitis treatment. It achieves high concentrations in the gut with low systemic exposure, demonstrating potential for reduced disease activity.

Keywords:
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Area of Science:

  • Gastroenterology
  • Immunology
  • Pharmacology

Background:

  • Systemic Janus kinase (JAK) inhibitors are effective for ulcerative colitis (UC) but associated with toxicities.
  • TD-1473 is an oral, gut-selective pan-JAK inhibitor developed to mitigate systemic toxicities.
  • Preclinical and clinical studies evaluated TD-1473's translation from in vitro characterization to Phase 1b efficacy in UC patients.

Purpose of the Study:

  • To assess the preclinical and clinical profile of TD-1473, a gut-selective pan-JAK inhibitor.
  • To evaluate the safety, pharmacokinetics, and efficacy of TD-1473 in healthy subjects and patients with ulcerative colitis.

Main Methods:

  • In vitro evaluation of TD-1473's JAK inhibition potency.
  • Pharmacokinetic and safety assessments in mice and healthy human subjects.
  • A 28-day Phase 1b study in UC patients randomized to TD-1473 (20, 80, or 270 mg once daily) or placebo, assessing safety, plasma/colonic concentrations, and efficacy endpoints.

Main Results:

  • TD-1473 demonstrated potent in vitro pan-JAK inhibition.
  • In mice, oral TD-1473 achieved high colonic concentrations with low plasma exposure, reducing colitis activity without affecting blood cell counts.
  • In humans, TD-1473 showed low plasma exposure, was well-tolerated, and achieved biologically active colonic concentrations, with trends toward reduced UC disease activity.

Conclusions:

  • Gut-selective pan-JAK inhibition with TD-1473 leads to high intestinal drug exposure relative to plasma.
  • TD-1473 demonstrates local target engagement in the colon.
  • The study indicates trends toward reduced ulcerative colitis disease activity, supporting further investigation.