Qu Biologics begins Phase 2 Clinical Trial in Crohn’s disease

Qu Biologics Inc. (Qu), a Vancouver, Canada-based biopharmaceutical company developing Site Specific Immunomodulators (SSIs), a unique platform of immunotherapies designed to restore innate immune function, is pleased to announce the receipt of a ‘No Objection Letter’ (NOL) from Health Canada and the initiation of their follow-on Phase 2 clinical trial to study QBECO SSI for treatment of Crohn’s disease (CD).

Patient screening and enrolment will commence shortly at clinical trial sites in Vancouver and New Westminster, the first of 5 clinical trial sites across Canada, to be followed by sites in Vernon, British Columbia and Hamilton, Ontario. The study is designed to confirm the promising findings in Qu’s previous Phase 1/2 CD study. The aim will be to determine the optimal time-point to assess QBECO SSI induction of mucosal healing and remission with QBECO treatment in adults with moderate-to-severe Crohn’s disease. The initial 20-patient stage of the trial will be ‘open-label’, meaning that all 20 participants will receive QBECO SSI therapy.

Prior to this study, Qu Biologics’ QBECO SSI was assessed in two clinical trials in Crohn’s disease and ulcerative colitis (UC), with the following promising results:

  • High response and remission rates seen in anti-TNFα naïve CD patients at the Week 8 and Week 16 treatment time-points.CD patients previously treated with anti-TNFα drugs continued to improve through to Week 16 and thus, Week 16 and Week 26 remission induction time-points will be assessed in the current study.
  • Identification of specific blood immune markers known to be associated with innate immune activation and gut mucosal healing were found to be correlated with QBECO SSI response/remission in both CD and UC, suggesting that these biomarkers could be used to predict QBECO response in CD and UC.
  • The identification of common CD and UC related genotypes with a high likelihood of response to SSI, suggesting that personalized medicine could be applied to CD and UC treatment for the first time, which would be an important advance in the treatment of these diseases.

“We are excited to initiate our next important study in Crohn’s disease to confirm the potentially transformative findings of our last study and to prepare the way for future pivotal studies in Crohn’s disease, stated Qu’s CEO, Dr. Hal Gunn. Jim Pankovich, VP Clinical Operations and Drug Development added, “Unlike current CD treatments that suppress immune function, QBECO SSI is designed to restore immune function. As such, rather than treating the end result of the disease, we believe that our novel approach, that addresses the underlying cause of the disease, could change the way this challenging disease is treated.”

To learn more about this clinical trial, visit www.quibd.com or email info@quibd.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 contact:

Hal Gunn, MD
CEO
Qu Biologics Inc.
Phone: 604 734 1450
Email: media@qubiologics.com
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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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