Vancouver, British Columbia – July 13, 2021 – Qu Biologics Inc., a clinical stage biotechnology company developing Site Specific Immunomodulators (SSIs), a novel platform of immunotherapies designed to restore innate immune function, is pleased to announce that data from Qu’s RESTORE clinical trial was presented at the 16th Congress of the European Crohn’s and Colitis Organization (ECCO). Selected for oral presentation, the data was presented on Saturday, July 10th by the study’s Principal Investigator, Dr. Brian Bressler, Director of the Advanced IBD Training Program at the University of British Columbia. The Phase 2 RESTORE study assessed the efficacy of Qu Biologics’ QBECO SSI for the induction and maintenance of clinical and endoscopic response and remission in 20 patients with moderate-to-severe Crohn’s Disease over a 52-week treatment period.
In contrast to current inflammatory bowel disease (IBD) treatments, which are focused on symptom management through aggressive and lifelong immune suppression, QBECO SSI is a first-in-class immunotherapy designed to restore normal innate immune and barrier function in the gastrointestinal tract to overcome the bacterial invasion and resulting unproductive chronic inflammation that is characteristic of Crohn’s disease. The RESTORE study, presented at ECCO 2021, demonstrated both symptom improvement/remission and endoscopic response. Clinical symptom and endoscopic response occurred in both patients who were naïve to previous immunosuppressive biologic therapies and in those who had previously failed these therapies. The RESTORE study group tended to be comprised of patients considered to be more difficult to treat – study patients had had disease for an average of 14.4 years and 60% had previously failed immunosuppressive biologics therapy. Despite this, clinical remission was achieved by 45% of patients at Week 16 by intention to treat analysis (ITT). Endoscopic response by central blinded read (defined as a reduction in SES score of 50% of more) occurred in 30% of patients during the study, including 38% (3/8) of biologics-naïve patients and 25% (3/12) of biologics-failed patients. Histological response (based on endoscopic biopsies) was also observed, with a decrease in GHAS score of 8 points (ITT analysis) during the 52-week QBECO treatment period, indicative of tissue healing. As observed in previous studies, QBECO safety profile was very good.
“The compelling clinical symptom, endoscopic and histological response data from our RESTORE study demonstrates a clear biologic response and provides exciting evidence that our novel approach to Crohn’s disease treatment may open the door to a new way of understanding and treating this very challenging disease. Historically, Crohn’s disease has been treated with life-long immune suppression. Data from this trial suggests that Crohn’s disease can be treated in an entirely different way by restoring innate immune function, which may be transformational in this disease,” stated Dr. Hal Gunn, CEO of Qu Biologics. Dr. Gunn added, “This Phase 2 Restore trial study provides additional clinical data to our two previously completed IBD studies in patients with Crohn’s Disease and ulcerative colitis, all of which consistently demonstrate therapeutic response, including clinical symptom relief and endoscopic and histologic improvement with QBECO SSI treatment.” Dr. Brian Bressler, the study’s Principal Investigator stated, “The results from the Restore trial show a clear signal that QBECO can have a positive effect on the inflammatory burden caused by Crohn’s disease. With these results, moving forward with a definitive study in Crohn’s disease must be a priority.”
About Qu Biologics
Qu Biologics is a clinical stage biotechnology company developing Site Specific Immunomodulators (SSI), a novel class of immunotherapies designed to stimulate an innate immune response in targeted organs to reverse the immune dysregulation underlying many important diseases including cancer, inflammatory bowel disease, infection, and inflammatory lung diseases. Qu has completed four Phase 2 studies in lung cancer, Crohn’s disease, and ulcerative colitis. Qu’s 5th Phase 2 study is underway in colon cancer, with three more Phase 2 randomized controlled oncology studies planned in pancreatic cancer, lung cancer and colon cancer.
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, please visit www.qubiologics.com.
For more information regarding this press release, contact:
Hal Gunn, MD
Qu Biologics Inc.
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.Posted on