The study (NCT03472690) is recruiting up to 20 adult Crohn’s patients at three sites in Canada — New Westminster, British Columbia; Vancouver, BC; and Hamilton, Ontario. To apply, patients will be asked 16 questions on a trial questionnaire that will assess their eligibility for the study.
All participants must had Crohn’s disease for at least three months, and should not have taken biologic therapies 60 days prior to the start of the study. Disease activity must have been previously confirmed by endoscopy and the evaluation of clinical symptoms.
In this part of the study, the patients will be treated with 0.1ml QBECO by self-administered subcutaneous injection every other day for up to 52 weeks. At weeks 16, 26, and 52 the effectiveness of the treatment in promoting a positive response, and disease remission, will be assessed by endoscopy.
All study-related fees and traveling expenses will be covered by the study’s sponsor, Qu Biologics.
Those interested in participating in the trial or for more information should contact a clinical trial representative by phone at 1-877-223-8637, by e-mail at [email protected], or by going to the Qu’s RESTORE trial webpage here.
Pending the results of this first treated group of patients, the trial will be expanded to include about 150 Crohn’s patients who will be recruited internationally.
In the second part of the trial the participants will be randomized to receive QBECO SSI or a placebo in the same regimen of subcutaneous injections every other day for up to 52 weeks.
“Qu’s QBECO SSI is designed to correct the innate immune suppression that underlies Crohn’s disease, unlike current drugs that treat the end result of the disease by suppressing immune function,” Hal Gunn, MD, the CEO of Qu Biologics, said in a press release.
“By restoring innate immune function, we are hopeful that our novel treatment approach may achieve long-term remission or cure off medications,” he added.
The experimental QBECO SSI immunotherapy is based on a site specific immunomodulator derived from inactivated bacteria that specifically targets the gut. This strategy takes advantage of a naturally occurring mechanism to support an immune response that will ease the symptoms of IBD.
Results from a previous Phase 1/2 study (NCT01809275) showed that 50% of patients with moderate to severe Crohn’s disease achieved clinical remission after eight weeks of treatment with QBECO SSI, compared to 23% of placebo-treated patients.
In another Phase 2 trial (NCT02426372), researchers showed that 16 weeks of treatment with QBECO SSI could induce clinical response in 73% of treated patients with ulcerative colitis, as well as endoscopic healing in 45% of patients.
Qu Biologics will sponsor an “Ask an Expert” webinar that was planned to provide further insights on integrative approaches to manage Crohn’s disease, and how QBECO SSI correlates with this type of treatment strategy.
Taking place at 4 p.m. Pacific time on Aug. 9 (7 p.m. Eastern time), the webinar will be presented by Dr. Seema Kanwal and Dr. Chris Spooner, naturopathic doctors. Shirin Kalyan, PhD, director of scientific innovation at Qu Biologics, will moderate a panel discussion.
To participate in the webinar send an e-mail to [email protected] (write Webinar Registration in the subject field) to book one of the 50 spots available, or go to this webpage and follow the instructions.