Enrollment into this clinical trial has completed and we are no longer enrolling new participants.
Results from Qu Biologics’ clinical study in Crohn’s disease
Qu Biologics’ 68-patient, randomized, placebo-controlled clinical study involved the use of investigational treatment QBECO SSI for moderate-to-severe Crohn’s disease.
The high-level results are as follows:
- QBECO SSI appears safe and well-tolerated;
- QBECO SSI treatment was associated with consistently positive trends in response, improvement and remission throughout the treatment period of the trial, establishing proof-of-concept in Crohn’s disease;
- Data from the trial improves our understanding of QBECO SSI treatment and, potentially, who might most benefit; and
- Results support continued development of QBECO SSI for the treatment of inflammatory bowel disease.
If you are interested in participating in and receiving updates about future clinical trials in Crohn’s disease involving Qu Biologics’ Site Specific Immunomodulators (SSIs), please email firstname.lastname@example.org indicating your request.
We sincerely appreciate your interest in our research of immune dysfunction in inflammatory bowel disease and our exploration of a new treatment option for Crohn’s disease.
|QBECO Clinical Trial Summary|
|Description||Phase 1/2, randomized, placebo-controlled, double-blinded study for adults with moderate to severe Crohn’s disease.|
|Screening period||Up to six weeks|
|Study period||24 weeks (16 week treatment period)|
|Location||Vancouver (BC), Edmonton (AB), Calgary(AB), Toronto (ON), Hamilton (ON)|
|Number of participants||68|
|Administration||Subcutaneous injection (just under skin) using fine needle, like an insulin injection|
Qu Biologics’ proprietary Site Specific Immunomodulators (SSIs) are investigational treatments containing a preparation of a single species of killed bacteria that were developed to stimulate the immune system in a tissue- and/or organ-specific manner, to reverse the chronic inflammation underlying many conditions including cancer, arthritis, and inflammatory bowel disease. QBECO is comprised of a preparation of a single species of killed bacteria that commonly infects the colon. It is being studied for its potential to treat Crohn’s disease.
The clinical trial for QBECO was a Phase 1/2, randomized, placebo-controlled, double-blind clinical trial for adult participants with moderate-to-severe Crohn’s disease. Participants (total number = 68) were randomized 1:1 to receive either QBECO (34 participants) or placebo (34 participants) for the first eight weeks of the study. At eight weeks, participants were assessed, and all participants who had responded to treatment continued their assigned therapy for the remaining eight (8) weeks (16 weeks total), while all participants who had not yet responded to treatment were provided ‘open-label’ QBECO for an additional eight weeks. The objectives of this study were two-fold: 1) to evaluate the safety profile and 2) to obtain an indication as to the therapeutic efficacy of QBECO induction treatment on clinical improvement (defined as a decrease in CDAI) in Crohn’s disease participants.