Vancouver, British Columbia – December 18, 2019 – Qu Biologics Inc., a biopharmaceutical company developing Site Specific Immunomodulators (SSIs), a novel immunotherapy platform designed to restore innate immune function, is pleased to announce the completion of enrollment for the first stage of the RESTORE clinical trial, “A Phase 2, Multi-center, Randomized, Double-Blind, Placebo-Controlled Study of QBECO SSI for the Induction and Maintenance of Clinical and Endoscopic Remission in Subjects with Moderate to Severe Crohn’s Disease”.
In this open-label first stage of a 170-patient study, 20 patients with moderate to severe Crohn’s disease will be treated for up to 52 weeks with the novel investigational agent, QBECO SSI, which is designed to restore, rather than suppress, immune function. Throughout the study treatment period, clinical symptom and endoscopic outcome data are being evaluated to determine the appropriate remission induction treatment period for the study’s next stage. The study also includes important exploratory endpoints correlated with QBECO SSI response, including immune biomarkers, histology and microbiome assessment.
This trial is a follow-on study to Qu’s first study in CD, which was a 68-patient randomized placebo-controlled trial designed to assess improvement of clinical symptoms with QBECO treatment over a 16-week period. This 68-patient study demonstrated a substantial decrease in Crohn’s disease activity index (CDAI) score after 8 weeks of treatment with continued improvement over the 16-week course of study treatment. Qu’s QBECO SSI achieved statistically significant improved response compared to placebo in anti-TNFα naïve patients in this small study, demonstrating proof-of-concept of this novel immunomodulatory approach. The results of Qu’s previous CD trial were published earlier this year in Frontiers in Medicine.
“Completion of enrolment in this first stage of our RESTORE Phase 2 study is an important milestone and we would like to thank the patients for their participation in this clinical trial”, stated Qu Biologics CEO Hal Gunn. “Through their contribution together with the Investigators and study staff, this trial will help us better understand the contribution that QBECO SSI may have on the treatment of this challenging disease and on improving lives of those with Crohn’s disease”.
The 150 patient second stage of the RESTORE Phase 2 randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the safety and efficacy of QBECO SSI for the treatment of moderate to severe CD subjects in Canada, the US and Europe. The endpoints of this study include the induction of clinical and endoscopic remission at week 16 and 26 and maintenance of remission assessed at week 52.
For more information about Qu Biologics and the science behind SSIs, please visit www.qubiologics.com.
For more information contact:
Hal Gunn, MD, CEO
Qu Biologics Inc.
Phone: 604 734 1450