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First stage of Qu Biologics’ clinical trial assessing mucosal healing for novel immunotherapy for Crohn’s disease reaches 50% enrolment
VANCOUVER, British Columbia, Nov. 13, 2018 (GLOBE NEWSWIRE) -- Qu Biologics Inc. (Qu), a biopharmaceutical company developing Site Specific Immunomodulators (SSIs), a unique platform of immunotherapies designed to restore the body’s innate immune system, has enrolled 10 of the 20 patients with moderate to severe Crohn’s disease (CD) to be included in the first stage of their Phase 2 clinical trial designed to demonstrate mucosal healing with SSI treatment. The study was initiated in May of 2018 and has 3 sites enrolling patients across Canada: 2 in British Columbia and 1 in Ontario. This is Qu’s second Phase 2 study in CD. The first was a randomized placebo-controlled trial which demonstrated improvement of clinical symptoms with SSI treatment. The current study includes assessment of mucosal healing by endoscopic evaluation, which is now accepted as the most objective assessment of efficacy in CD and the endpoint most highly correlated with long-term outcome.
CD is a chronic life-long inflammatory disease of the gastrointestinal (GI) tract. Current CD treatment strategies are focused on symptom management by aggressive immune suppression to dampen inflammation. Despite the growing arsenal of immunosuppressive agents, disease progression has not changed for the majority of CD patients, who often require surgery. Qu Biologics is approaching the treatment of this disease in a very different way. Instead of suppressing immune function, Qu’s treatment for CD, QBECO SSI, aims to restore innate immune function in the GI tract to rebuild barrier function and clear the dysbiosis/bacterial infection that underlies the chronic inflammation that is characteristic of the disease.
Enrollment for CD clinical studies is very competitive due to the large number of CD clinical trials underway. As a result, the average recruitment rate for CD trials is 0.6 – 1.2 patients per site per year. Qu has substantially exceeded the industry average recruitment rate, with 10 patients enrolled in 5 months at 3 sites. Among the reasons for this increased enrolment rate is the hesitancy many CD patients have of taking life-long immunosuppressive therapies and the perceived attractiveness of Qu’s approach to restoring, rather than suppressing, immune function. The latter may thus change disease progression.
Dr. John Marshall, Director of Gastroenterology at McMaster University, was involved in Qu’s first CD trial and is the principal investigator for the current trial in Hamilton. In a recent interview, he stated, “[Qu’s] is a very different therapy… Our early experience with this approach has shown success in patients who respond to this treatment and who continue to respond after treatment was completed.” Michelle Jones, Associate Director of Clinical Operations at Qu, added, “The novel approach of Qu’s investigational treatment provides an option for patients who are seeking an alternative to the current treatment paradigm.”
Dr. Hal Gunn, CEO of Qu Biologics stated, “We are pleased with the enrolment to date and look forward to the endoscopic remission/response data anticipated in Q2 2019.”
For anyone wanting to learn more about the trial or the possibility of participating, 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
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.