Enrollment into this clinical trial has completed and we are no longer enrolling new participants.
There is growing evidence that a defect or suppression of the innate immune system may underlie a variety of immune-related diseases, including ulcerative colitis. Qu Biologics is developing Site Specific Immunomodulators (SSIs), designed to restore the body’s normal immune response. In the case of ulcerative colitis, QBECO SSI, derived from components of inactivated E. coli, is designed to restore normal innate immune function in the colon and reverse the chronic inflammation and dysbiosis associated with the disease.
Qu Biologics has completed an open-label ulcerative colitis clinical trial to study of QBECO SSI treatment.
Results from Qu Biologics’ clinical study in ulcerative colitis
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 and remission within the first 16 weeks of the trial, establishing proof-of-concept in ulcerative colitis;
- 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.
Clinical trial for ulcerative colitis
Qu Biologics has completed a clinical trial for ulcerative colitis. In this clinical trial, all participants received QBECO SSI investigational treatment.
The trial is a Phase 2a, open-label, dose-ranging, proof-of-concept study to evaluate the safety, tolerability and efficacy of QBECO SSI for the treatment of patients with moderate-to-severe ulcerative colitis.
|QBECO SSI Ulcerative Colitis Clinical Trial Summary|
|Description||Phase 2a, open-label, dose-ranging, proof-of-concept study to evaluate the safety, tolerability and efficacy of QBECO SSI for the treatment of patients with moderate-to-severe ulcerative colitis.|
|Study Period||Up to 56 weeks|
|Locations||Multi-centre in Canada (Vancouver, Edmonton, Hamilton)|
If you are interested in keeping up to date on the status of Qu’s clinical trials for ulcerative colitis, you may sign up to receive updates.
Patients with ulcerative colitis treated in a compassionate use program
Two patients with moderate to severe ulcerative colitis uncontrolled with standard treatments were treated with QBECO SSI therapy in a compassionate use program. Both patients observed improvement in symptoms (i.e., reduced bowel movement frequency, reduced urgency, and reduction of blood in stool) within three weeks of initiation of treatment. Both patients went into sustained clinical remission after discontinuing all treatment including QBECO SSI treatment. Both patients are in ongoing sustained remission, off all medications (more than 4 years after starting SSI treatment).
It is important to note that the data collected were neither placebo-controlled nor ‘blinded’ to the physician or patient. Accordingly, they represent a retrospectively-acquired, preliminary experience from which proof of benefit of QBECO SSI treatment cannot be established. However, these observations are promising and provide the precedent for a prospective controlled clinical study of QBECO SSI treatment in patients with moderate to severe ulcerative colitis.