Qu Biologics is preparing for their first clinical trial, to evaluate one of their lead candidate Site Specific Immunomodulators (SSIs), QBECO, for the treatment of Crohn’s Disease. The trial will be a phase 1/2 randomized, placebo-controlled, double-blind study of the induction of clinical response and remission by QBECO in subjects with moderate to severe Crohn’s disease. The trial is planned to take place in a single site in Vancouver, B.C., Canada.
The main purpose of this study will be to test whether the investigational treatment, QBECO SSI, is safe and effective for the treatment of Crohn’s disease.
For this initial study, Qu Biologics anticipates recruiting sixty (60) subjects whom will be randomized to one of two study treatment groups: 30 patients will receive QBECO, and 30 patients will receive placebo. After eight (8) weeks, patients will be evaluated for therapeutic response. All patients who have responded to therapy will continue their current study treatment for an additional eight (8) weeks, while all patients who have failed to respond adequately to their study treatment will be provided with “open-label” QBECO SSI for eight (8) weeks. It is anticipated that study participation will take 24 weeks with three (3) clinic visits. It is expected that the entire research study will take approximately 18 months.
Further details about the trial and patient eligibility will be made available through a dedicated website (www.qucrohnstrial.com) to be launched in early 2013.
In the meantime, we invite people interested in learning more about Qu Biologics’ promising approach to immunomodulation for Crohn’s disease to contact us at [email protected]