Qu Biologics publishes potentially paradigm-shifting results of their first randomized-placebo controlled trial for the treatment of Crohn’s disease

Home » Clinical Trial Updates » Qu Biologics publishes potentially paradigm-shifting results of their first randomized-placebo controlled trial for the treatment of Crohn’s disease

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.

About Qu Biologics
Qu Biologics is a Vancouver-based private clinical stage biopharmaceutical company developing Site Specific Immunomodulators (SSI), a novel class of immunotherapies. SSIs are designed to stimulate an innate immune response in targeted organs or tissues to reverse the chronic inflammation underlying many conditions including cancer, inflammatory bowel disease, inflammatory lung disease and arthritis. SSIs are a broad platform technology being tested in multiple disease indications, including Health Canada approved clinical trials in lung cancer, Crohn’s disease and Ulcerative Colitis.

Backed by a prestigious group of scientific advisors and board members, Qu Biologics is led by a management team that includes co-founder and CEO Dr. Hal Gunn, a physician and expert on the body’s immune response to chronic disease; and Chief Medical Officer Dr. Simon Sutcliffe, former CEO of the BC Cancer Agency and a distinguished clinician, scientist and leader in cancer control in Canada and internationally.

For more information regarding this press release, contact:

Hal Gunn, MD
CEO Qu Biologics Inc.
Phone: (1) 604.734.1450
Email: media@qubiologics.com

Qu Biologics Inc. cautions you that statements included in this press release that are not a description of historical facts may be forward-looking statements. Forward-looking statements are only predictions based upon current expectations and involve known and unknown risks and uncertainties. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of release of the relevant information, unless explicitly stated otherwise. Actual results, performance or achievement could differ materially from those expressed in, or implied by, Qu Biologics’ forward-looking statements due to the risks and uncertainties inherent in Qu Biologics’ business including, without limitation, statements about: the progress and timing of its clinical trials; difficulties or delays in development, testing, obtaining regulatory approval, producing and marketing its products; unexpected adverse side effects or inadequate therapeutic efficacy of its products that could delay or prevent product development or commercialization; the scope and validity of patent protection for its products; competition from other pharmaceutical or biotechnology companies; and its ability to obtain additional financing to support its operations. Qu Biologics does not assume any obligation to update any forward-looking statements except as required by law.

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