Vancouver, British Columbia – January 4, 2021 – Qu Biologics Inc., a private clinical stage biopharmaceutical company developing Site Specific Immunomodulators (SSIs), a novel platform of immunotherapies designed to restore innate immune function, is pleased to report positive signs of clinical, endoscopic and histologic response in subjects participating in Stage 1 of their Phase 2 RESTORE trial for the treatment of patients with moderate-to-severe Crohn’s disease. These positive signals emerged from a recently completed interim analysis of Stage 1, which is designed to assess the optimal timepoint to measure endoscopic response induction in patients treated with QBECO, Qu’s gastrointestinal-targeted SSI.
Crohn’s disease is a type of chronic inflammatory bowel disease (IBD) that is clinically characterized by abdominal pain, severe diarrhea, fatigue, malabsorption, and gastrointestinal distress. Current treatments are focused on symptom management through aggressive immune suppression, which can be associated with an increased risk of infection and certain types of cancers. In contrast, Qu’s QBECO is designed to restore immune and barrier function in the gastrointestinal tract to overcome the damaging unproductive inflammation that patients with IBD experience.
“We are very encouraged to see QBECO demonstrate an objective biologic effect in the gastrointestinal tract of patients with Crohn’s disease, especially since this has been difficult to achieve and maintain with current therapies,” said Jim Pankovich, Qu’s VP of Clinical Operations and Drug Development. “These therapeutic signals were noted across a range of important endoscopic, histological and serological parameters,” noted Dr. Hal Gunn, CEO of Qu, “We are excited at QBECO’s potential to transform the way Crohn’s disease is treated and to meaningfully improve health outcomes of people living with this challenging disease.”
Results from Stage 1 of the RESTORE Trial are anticipated to be available in February 2021. This data will inform the design of Stage 2 of the study, which is planned to be a larger international randomized placebo-controlled trial (n=150) for the treatment of patients with moderate-to-severe Crohn’s disease.
For more information about Qu Biologics and the science behind SSIs, please visit www.qubiologics.com.
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 chronic inflammation underlying many important diseases including inflammatory bowel disease, cancer, inflammatory lung disease and arthritis. Qu has completed three Phase 2 studies in Crohn’s disease, ulcerative colitis and lung cancer and has two Phase 2 studies underway in Crohn’s disease 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 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.