Vancouver, British Columbia – July 23rd, 2019 – Qu Biologics Inc. (Qu), a biopharmaceutical company developing Site Specific Immunomodulators (SSIs), a unique platform of microbial-based immunotherapies designed to restore the body’s innate immune system, is pleased to report that the results of their first randomized-placebo controlled trial (RCT) in patients with moderate-to-severe Crohn’s disease (CD) was accepted for publication in Frontiers in Medicine, an open-access peer-reviewed medical journal. This pivotal work is the first to demonstrate that clinical symptoms of CD can be improved with an immunomodulatory treatment that functions to activate instead of suppress the immune system.
Treating CD, a life-altering inflammatory bowel disease, by selectively activating the immune system to enhance barrier function in the gastrointestinal tract is considered counter-intuitive to many given the current standard of care involves aggressive immune suppression to manage symptoms of the disease. Dr. Hal Gunn, CEO of Qu Biologics, said about the promising trial results, “If our subsequent CD trials confirm that this unique approach ameliorates disease, even in a subset of patients, it would be transformative for our understanding of the disease and the treatment of patients. Despite the large arsenal of immunsuppressive therapies used to manage CD symptoms, the trajectory of the disease has not changed for the majority of patients, most of whom end up requiring surgery.” Immunologist Dr. Shirin Kalyan, Qu’s Director of Scientific Innovation, further noted, “Importantly, long-term immune suppression comes with consequent risks, such as an increased risk of certain cancers and serious infections, that many patients with Crohn’s disease would prefer to avoid if possible. We hope that SSIs can provide them another option – one that aims to enhance their immune resiliency.”
At the time Qu initiated the first CD trial, the Crohn’s Disease Activity Index (CDAI) was the instrument of choice to evaluate how well a treatment was working in patients with CD. However, the bar for evidence is shifting, and there is now a greater emphasis on obtaining objective evidence for mucosal healing in the intestinal tract via endoscopy. Qu is currently running a follow-on trial, which is enrolling at three sites across Canada, to evaluate mucosal healing with SSI treatment. This follow-on trial is 85% enrolled, but interested patients with moderate-to-severe CD can still inquire about participation. Dr. John Marshall, Director of Gastroenterology at McMaster University, who is a co-author of the recently published study, is one of the principal investigators of the current trial. He discussed in an earlier interview how very different the SSI approach is to current CD treatments and his patients’ experience to date with SSI therapy.
For anyone wanting to learn more about Qu’s current follow-on CD trial or the possibility of participating, please see https://www.quibd.com/.
For more information about Qu Biologics and the science behind SSIs, please visit www.qubiologics.com.
For more information contact:
Hal Gunn, MD, CEO