“SSIs offer an innovative, novel approach to improving care within the context of trusted, credible scientific studies.”
~ Dr. Simon Sutcliffe, Chief Medical Officer, Qu Biologics
Do you have Crohn’s Disease?
Qu Biologics has developed QBECO SSI, an investigational treatment designed to restore normal immune function. We have completed enrollment of a 68-patient randomized, placebo-controlled clinical trial for the treatment of Crohn’s disease. Initial results from this study are now available (see below).
Qu Biologics’ proprietary Site Specific Immunomodulators (SSIs) are investigational treatments designed to restore normal immune function in the targeted tissue to reverse the chronic inflammation underlying many chronic illnesses, including Crohn’s disease. E. coli is a bacterium that is a common cause of gastrointestinal infection. QBECO SSI is derived from components of inactivated E. coli and aims to simulate infection without causing it and, in so doing, stimulates a targeted innate immune response in the gastrointestinal tract to clear the chronic infection and dysbiosis that may underlie Crohn’s disease. Read more about QBECO SSI treatment for Crohn’s disease and how SSIs work.
Initial 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 preliminary 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.
Plans underway to begin multi-center clinical trial in Crohn’s disease
We have begun planning for a multi-center clinical trial of our lead program in Crohn’s disease. If you are interested in receiving updates on the status of a future clinical trial for Crohn’s disease involving QBECO SSI, please email us at email@example.com.
Join our IBD Community Advisory Panel
If you are someone living with inflammatory bowel disease or are a caregiver, we’d like to hear from you! You could make a difference in how our clinical trials are designed. Learn more about joining our IBD Community Advisory Panel.
Ten patients with Crohn’s disease treated in compassionate use program
In a compassionate use program, ten patients with uncontrolled moderate to severe Crohn’s disease were treated with QBECO SSI treatment in addition to their current standard medical treatments and/or complementary therapies. The results from the compassionate use program were:
- All ten patients reported improvement in symptoms while on SSI treatment.
- Eight of the ten patients were able to discontinue all other medications at some point while on QBECO SSI treatment.
- Seven of the ten patients reported full resolution of clinical symptoms during a course of QBECO SSI treatment of 2.5 months or more.
- Three of these patients are in ongoing sustained clinical remission, after discontinuing all medications including SSI treatment.
- The longest remission is ongoing since July 2010 (discontinued all medications, including SSI treatment since July 2011).
- All three patients in ongoing sustained remission have had follow-up colonoscopies or imaging confirming remission.
It is important to note that data collected from the compassionate use program were neither placebo-controlled nor ‘blinded’ to the physician or patient. Accordingly, they represent a retrospectively-acquired, cumulative, preliminary experience from which proof of benefit of QBECO SSI treatment cannot be established. However, these observations are promising and are the precedent for the Health Canada approved prospective, randomized, placebo-controlled, double-blinded clinical study of QBECO SSI treatment in patients with active, moderate-to-severe Crohn’s disease.