Vancouver, British Columbia – April 19th, 2017 – Qu Biologics Inc., a biopharmaceutical company developing Site Specific Immunomodulators (SSIs), a unique platform of immunotherapies designed to restore the body’s innate immune system, reports high response and remission rates in anti-TNFα naïve patients in its recently completed randomized, placebo controlled trial in moderate to severe Crohn’s disease (CD). In the study, treatment with QBECO SSI for 8 weeks resulted in a statistically significant response rate of 64% compared to 27% in the placebo control (p=0.041). Clinical remission rates after 8 weeks of treatment were also impressive at 50%, more than double the placebo rate of 23% (p=0.16).Clinical response and remission rates were assessed using the standard Crohn’s Disease Activity Index (CDAI), defined as a decrease in CDAI of ≥70 points (response) and CDAI score ≤150 points (remission).
Dr. Brian Bressler, UBC Clinical Assistant Professor ofMedicine, Division of Gastroenterology, and Principal Investigator of the trial, explained, “Remission rates in similarly designed randomized placebo controlled trials with current ‘gold-standard’ treatments for CD, Remicade® and Humira®, are approximately 35% in anti-TNFα naïve patients at similar time-points, so the 50% remission rate in this important patient group in this trial is promising.” Dr. Hal Gunn, CEO of Qu Biologics, added, “We are pleased with the high response and remission rates in the QBECO-treated anti-TNFα naïve CD patients at the early Week 8 time-point, particularly as data from the trial suggests that many patients continue to improve on SSI treatment after this time-point. Future studies will assess response and remission rates with longer treatment periods.”
Anti-TNFα naïve patients (i.e., patients who have not been treated with the immunosuppressive drugs Remicade®, Humira®, Cimzia® and Simponi®) represent approximately two-thirds of Crohn’s disease patients in Europe and North America and a higher percentage of patients elsewhere. Patients who have previously been treated with and failed anti-TNFα agents are known to be a more difficult to treat patient group. Data from the trial’s cytokine analysis suggests that patients previously treated with anti-TNFα agents may have greater baseline innate immune suppression/dysregulation. SSI treatment is designed to restore innate immune function and therefore, a longer period of SSI treatment may be required in this latter patient group. As Jim Pankovich, Qu Biologics’ VP Clinical Operations and Drug Development noted, “In patients previously been treated with TNFα inhibitors who completed 16 weeks of SSI treatment, 40% were in remission, suggesting that this more challenging patient group may respond to QBECO SSI with longer treatment.”
Dr. Hal Gunn added, “When this data is combined with the genetic and cytokine biomarker data from the trial, it suggests that we may be able to select patient groups with an even higher probability of response and remission with QBECO SSI treatment. These results are very encouraging and will guide us in the design of our next study and in future Phase 3 studies.” Qu Biologics plans to initiate a larger follow-on clinical trial in Crohn’s disease in late 2017/early 2018 with a 52-week QBECO SSI treatment period.
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.
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