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COMPANY

NImmune Biopharma

nimmunebio.com ↗

Clinical Phase 2

Profile checked Oct 10, 2026

Keywords: Crohn's Disease Ulcerative Colitis Eosinophilic Esophagitis BT-11 NIM-1324

6Trials (company is sponsor)

Timeline

  1. Trial start Phase 1: Safety and Pharmacokinetics of Orodispersible BT-11 in Active Eosinophilic Esophagitis source ↗
  2. Trial start Phase 2: Safety and Efficacy of Oral BT-11 in Crohn's Disease Patients With Moderate to Severe Disease source ↗
  3. Trial start Phase 1: Safety Tolerability and Pharmacokinetics of Oral NIM-1324 in Healthy Adult Male and Female Volunteers source ↗
  4. Trial start Phase 2: Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease source ↗
  5. Trial start Phase 2: Efficacy and Safety of Oral BT-11 in Ulcerative Colitis source ↗
  6. Trial start Phase 1: Safety, Tolerability, and Pharmacokinetics of Oral BT-11 in Healthy Adult Male and Female Volunteers source ↗

Clinical trials (lead sponsor) 6

RecordTitlePhaseStatusStartPrimary completion
NCT03870334Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's DiseasePhase 2TerminatedMay 5, 2021Aug 26, 2022 (actual)
NCT03861143Efficacy and Safety of Oral BT-11 in Ulcerative ColitisPhase 2CompletedAug 14, 2019Dec 10, 2020 (actual)
NCT05019950Safety Tolerability and Pharmacokinetics of Oral NIM-1324 in Healthy Adult Male and Female VolunteersPhase 1CompletedOct 28, 2021Apr 28, 2022 (actual)
NCT05057273Safety and Efficacy of Oral BT-11 in Crohn's Disease Patients With Moderate to Severe DiseasePhase 2Withdrawn2021-112022-02 (estimated)
NCT04835168Safety and Pharmacokinetics of Orodispersible BT-11 in Active Eosinophilic EsophagitisPhase 1WithdrawnJan 30, 2022Apr 30, 2022 (estimated)
NCT03860571Safety, Tolerability, and Pharmacokinetics of Oral BT-11 in Healthy Adult Male and Female VolunteersPhase 1CompletedJul 6, 2018Sep 24, 2018 (actual)
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