QBECO SSI General Questions
As QBECO SSI is an investigational drug, we are still collecting data to understand the adverse events associated with it. The most commonly reported adverse events have been injection site reactions, flu-like symptoms, nausea, fatigue and fever.
QBECO is derived from components of E. coli and is intended to restore innate immune function. The innate immune system is not specifically designed to clear E.coli, however once activated it can clear a wide range of fungal, viral and bacterial pathogens.
Past studies have been designed to evaluate symptoms of Crohn’s disease so there is limited information available regarding improvement of extra-intestinal manifestation such as arthritis. To date, it does not appear that these symptoms would get worse on QBECO treatment.
QBECO is designed to restore innate immune function, which is not specific, therefore once activated, the innate immune system has the potential to clear infection of a wide variety of viral, fungal and bacterial pathogens.
The genes correlated with QBECO response are of high relevance to our drug’s mechanism of action. They are genes that control innate immune response particularly around the clearance of bacterial infection.
Current treatments for Crohn’s Disease and Ulcerative Colitis suppress the adaptive immune system and must be taken on an ongoing basis for as long as the treatment works. Unfortunately, loss of response to those immunosuppressive drugs often occurs so people switch to another immunosuppressant until it stops working as well. QBECO-SSI treats the disease in a very different way. The goal is to restore innate immune function. People with Crohn’s disease have reduced innate immune function. While there is no consensus on the cause on Crohn’s disease, many researchers are now thinking about the disease in terms on an innate immune system suppression or dysregulation with an inability to clear bacterial infection and dysbiosis and the adaptive immune system then reacting to that bacterial infection. Suppressing that adaptive immune response does not address the underlying innate immune system dysregulation or the bacterial infection and dysbiosis. Typically, when you stop treatment with immunosuppressants symptoms come back.
QBECO-SSI treatment is designed to restore innate immune function and to clear bacterial infection and dysbiosis. Once that infection is cleared, there is nothing left to trigger the adaptive immune system. We are hopeful that our treatment may, at least in a portion of patients, create sustain remission off medications. In the first 12 patients that we treated more than 6 years ago, 5 of those patients with moderate to severe inflammatory bowel disease are still in remission after completing a course of 3 to 12 months of QBECO treatment.
QBECO-CD-02 General Questions
The colonoscopy, which is done at screening and at other 3 points throughout the first stage of the study, will also be looking at the end of the small bowel and assess activity in the ileum.
To participate in the clinical study (QBECO-CD-02), patients must have moderate to severe disease as measured by clinical symptoms, abdominal pain &/or stool frequency, and colonoscopy evaluation.
Our product is an investigational agent in a Phase 2 clinical development program. One aspect of drug development is that it can take a long time to understand how the product works, and how to use it effectively and safely. Realistically, it will be several years before the product completes all the required clinical trials and obtains market authorization approval from a health board for commercialization. Until then, the product will be available through participation in clinical trials.
In the last study (QBECO-CD-01), it was found that some patients responded quite quickly to treatment with improved symptoms, other patients took longer to respond to treatment. Response continued in most patients right through to 16 weeks of treatment. The question of how long it might take for a particular patient to respond is something we are still exploring and will be an important part of QB0ECO-CD-02.
This is unknown at this time, so for the clinical study only participants that are not pregnant or planning to become pregnant will be eligible. Study participants will also be asked to utilize contraceptive methods during the course of the study.
QBECO-CD-02 Location and Trial Logistics
For stage 1, all trial sites will be in Canada. Currently there will be sites in British Columbia (Vancouver, New Westminster, Vernon), Ontario (Hamilton), with possible sites in Alberta (Edmonton).
We have received approval from Health Canada for the start of the trial. We anticipate that the first site will be operational in May 2018 and that the rest of the sites will be ready to accept patients by June 2018.
If it’s feasible for you to enter the trial, Qu Biologics will pay for travel all expenses including a car or in some cases a flight.
If you are potentially eligible for the study, you will be referred to the closest clinical trial site for further follow-up.
For stage 1 of the study, no sites are planned for the Maritimes, but we could add a site there for a future part of the study.
The insurance for our study in Canada is limited to patients who are residents of Canada and have provincial health insurance. Unfortunately, USA patients can not join our 20-patient study but are very welcome to join our follow-on 150 patient study. We will have multiple trial sites in the USA and likely trial sites in Europe.
Trial sites for the second stage of the study are planned for Canada and United States. Specific locations in the US have not yet been identified.
We will work with the regulators to try to make the drug available after the end of the clinical trial for patients who respond to the drug. There is no guarantee that regulators will allow that, but we know access to the drug beyond the study is important to patients and we will do our best to achieve it.
In our last study we used the Crohn’s Disease Activity Index (CDAI), which is mostly a symptoms measurement score. In this trial, we will be looking at endoscopic healing, which is the most objective endpoint to assess response to treatment. We will also measure clinical symptoms as well as specific biomarkers response.
We won’t be testing people for that infection before and after QBECO treatment. Our treatment is designed to restore innate immune function, so we are hopeful that if patients do have a MAP infection that the restored immune system will be able to clear it.
In order to join the study, you must to have both the symptoms of Crohn’s disease (increased amount of bowel movements and/or abdominal pain) and active disease on colonoscopy (evidence of ulceration and inflammation).
You must have both active symptoms and evidence of inflammation on colonoscopy to enter the study.
Unfortunately, that is an exclusion criterion for the study. You can have a history of small bowel resection if you are not symptomatic from having too much of your small bowel removed. However, if you have an ostomy then you would be excluded from joining the study.
Patients with an ostomy are not eligible to participate in the study.
In our completed Ulcerative Colitis study, we had 73% response rate and we showed histological improvement on colonoscopy. We are excited about the potential of our treatment in Ulcerative Colitis but in this trial only Crohn’s Disease patients will be eligible.