“Part #1” Crohn’s Disease Phase 2 Clinical Trial

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UPDATE: Jan-6-2021, Part #1 of Crohn’s trial has completed

View our official press release here


Despite the ever-growing number of immunosuppressive drugs used for the treatment of Crohn’s disease, the course of disease progression has not changed for the majority of affected patients. Qu’s approach is not to suppress the symptoms of disease (which is the focus of current therapies) rather, Qu’s QBECO SSI is intended to restore innate immune function and achieve sustained remission off all medications. This would be transformative for those living with Crohn’s disease.

Qu’s Phase 2 clinical trial for Crohn’s disease will be conducted in multiple stages or parts.

  • Part #1: Follow-on study, 20 Canadian patients enrolled in an open-label study, which finished in Dec-2020.
  • Part #2: Main Induction, a randomized and placebo-controlled trial that plans to include international patients.


The aim of Part #1 of our Phase 2 Crohn’s disease clinical trial is to further establish the safety and efficacy of the investigational drug QBECO SSI. Our clinical trial is named: QBECO-CD-02. This includes evaluating whether the treatment has an effect on the induction of clinical and endoscopic response and remission. The study will also help determine whether mucosal healing occurs after 16 or 26 weeks of QBECO SSI treatment. Enrollment started in mid 2018 and ended in late 2019. The last patients crossed the finish line in Dec-2020, which marked the end of Part #1 of our Phase 2 Crohn’s disease clinical trial. Preliminary data analysis suggests promising positive clinical signals that QBECO works. Qu Biologics anticipates fully analyzed results by Feb-2021 and we should have a clearer picture on how to move forward then.


For more information, check out our webinars about the trial.


Funding dependent, we anticipate that Part #2 of our trial will be a multi-centre, multi-national, randomized controlled trial. The timeline of the trial has not been set. If you would like to join a waiting list or be updated about Part #2 of the trial, please sign-up below.