Phase 2 Clinical Trial

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ABOUT OUR THERAPY

In the context of drug products, a biologic refers to any therapeutic agent that is derived from a natural source, including human, animal or microbe. This differs from chemical drugs that are synthesized and have a very defined structure. Biologics are complex mixtures, and they include a wide array of treatments such as vaccines, blood components, antibodies, and gene therapies.

The first biologics used for IBD have all been antibodies that target specific immune molecules to suppress/block inflammation and/or immune function. They have been designed to deal with the symptoms of IBD.  In contrast, QBECO is made from a micro-organism that is normally found in the gastrointestinal tract. Treatment with QBECO is not meant to suppress immune function; its aim is to properly activate and produce new immune cells to fix/rebuild the loss of barrier function in the gut that contributes to intestinal bacteria invading the tissues and causing chronic inflammation and dysbiosis. QBECO is thus believed to make the immune system more functional and resilient instead of blocking/inhibiting its dysfunction, the latter is what all current treatments aim to do.

ABOUT OUR TRIAL

Qu Biologics is now recruiting Canadian residents to participate in the first stage of a Phase 2 clinical trial of QBECO SSI in the treatment of adults living with moderate to severe Crohn’s disease.

The aim of this trial is to further establish the safety and efficacy of the investigational drug QBECO SSI for the induction of clinical and endoscopic response and remission. QBECO SSI is intended to restore innate immune function and achieve sustained remission off all medications. In addition, this study will help to determine whether improvement in endoscopic healing is seen after 16 weeks or after 26 weeks of treatment.

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

STUDY PROCESS

SCREENING QUESTIONNAIRE

Thank you for your interest in participating in Qu Biologics’ Phase 2 clinical trial of an investigational new treatment for Crohn’s disease. To apply to participate, you will be asked to take a short questionnaire (16 questions) so that a clinical doctor can assess your eligibility for this trial. The questionnaire and registration process will take about 10 minutes.

If at any time you have questions, you may speak with a Clinical Trial Representative at 1-877-223-8637 or cdtrial@quibd.com