An Innovative Investigational Treatment for Crohn’s Disease
Prevention and Treatment This clinical trial is about to change the Crohn's community as we know it. Learn what it is, how it works, and if you qualify to be apart of it.
The prevalence of Canadians living with Crohn’s disease is growing at a rapid rate. While there are currently 135,000 Canadians living with inflammatory bowel disease, that number is expected to rise by 50 percent by the year 2030.
Currently Crohn’s is considered an autoimmune disease, meaning the immune system goes awry, attacking and inflaming the body’s own intestinal lining. Treatment for Crohn’s typically includes medications aimed at managing the often-debilitating gut symptoms by suppressing immune function in the body. While these types of treatments are often effective, they need to be used on an ongoing, lifelong basis, may lose effectiveness over time, and can be associated with significant, and occasionally rare but serious side effects.
One Canadian biotech company hopes to provide a new way to treat patients living with Crohn’s disease. Qu Biologics Inc. is developing Site Specific Immunomodulators (SSIs), a novel platform of immunotherapies intended to restore — instead of suppress — particular elements of innate immune function.
“While we are hopeful that our novel treatment approach may achieve long-term remission and reduce treatment burden for patients, we need to carry out the clinical studies that will show the treatment is safe and effective” says Dr. Hal Gunn, CEO and Co-Founder of Qu Biologics.
The novel approach uses an investigational treatment called QBECO. QBECO comes from an inactivated gut-pathogen, which can be easily self-injected. The thinking behind the treatment is that by spurring the immune system into thinking it has an acute infection in the gut, it will activate and re-program innate immune cells to possibly improve regions of weak immune function in the gut. This ability to re-program innate immune cells using microbe-based stimulants is known as innate immune “training”.
This approach is based on a newer premise that Crohn’s may start in the first place because the immune system wasn’t able to clear gut pathogens due to a poor gut barrier function. This faulty barrier is an indication that the first line of defence of the immune system — the innate immune system — is not working optimally. Over-compensation by the adaptive immune system – the second line of defense — in response to the invading gut pathogens is thought to trigger the excessive, tissue-damaging immune response and inflammation that is characteristic of the disease. “With conventional treatments, the immune system of patients is made weaker,” explains Dr. Gunn. “This approach is a paradigm shift.”
Qu Biologics is currently conducting a phase 2 clinical trial for Canadians with moderate to severe Crohn’s disease. The company anticipates this trial will provide part of the evidence needed to establish QBECO safety and efficacy and support eventual marketing approval.
The company is actively recruiting patients in sites across Canada, including Hamilton, ON, New Westminster, BC and Vancouver, BC. If eligible, participants in the first study stage will receive the treatment for one year, via self-administered injections every other day. In the second stage QBECO will be compared to a placebo treatment.
“We will be assessing the clinical symptoms for each patient during the treatment period,” Dr. Gunn says. “Part of the assessment includes endoscopic examination to track any changes in the gastrointestinal tract, in addition to other tests for safety and effectiveness.”
For many Canadians suffering from Crohn’s, a lifetime of medication is a cumbersome course of treatment. Qu Biologics is encouraging patients who are interested and have moderate to severe Crohn’s symptom to visit restoretrial.ca to learn more and see if you are eligible by filling out the pre-screening questionnaire.
Approved by WIRB 11/19/2018, IRB#20180720.