Reversing Chronic Inflammation Underlying Ulcerative Colitis
There is growing evidence that 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 innate immune function in the colon and reverse the chronic inflammation and dysbiosis associated with the disease. Qu Biologics has initiated an ulcerative colitis open-label study of QBECO SSI treatment. Read more about how SSIs restore normal immune function.
Clinical trial for ulcerative colitis
If you would like to learn more about our ulcerative colitis clinical trial, visit our clinical trial website at http://www.quibd.com/ulcerative-colitis-information/.
Enrollment into this clinical trial has completed and we are no longer enrolling new participants.
If you are an adult living with active ulcerative colitis and are interested in enrolling in future ulcerative colitis clinical trials, please email firstname.lastname@example.org.
Learn more about Qu Biologics’ ulcerative colitis clinical trial and what to expect
The ulcerative colitis clinical trial was located at three sites in Canada including Vancouver (BC), Edmonton (AB) and Hamilton (ON).
While we plan to initiate an international, multi-centre clinical trial in ulcerative colitis in the future, the most recent ulcerative colitis clinical trial was approved in Canada and only enrolled Canadian residents.
If you are interested in keeping up to date on the status of Qu’s clinical trial for ulcerative colitis, you may sign up to receive updates.
If at any time you have any questions, you may email email@example.com.
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.
Based on the Week 8 and preliminary Week 16 results, QBECO SSI appears safe and well-tolerated and demonstrates consistently positive trends throughout the treatment period of the trial, successfully establishing proof-of-concept in Crohn’s disease and supporting continued development of QBECO SSI in inflammatory bowel disease.
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 had full resolution of symptoms and were able to discontinue all medications including 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 in the compassionate use program 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.