Qu Biologics opens Crohn’s disease clinical trial to US participants

Qu Biologics co-founder and CEO Dr Hal Gunn noted significant patient interest from the US in its Crohn’s disease clinical trial prompted us to open the trial to Americans.

"Enrollment into our trial is underway. We are pleased with the progress of the clinical trial and excited about the potential of SSI treatment for Crohn’s disease," Dr Gunn added.

Sixty adults with active moderate-to-severe Crohn’s disease are being recruited to evaluate Qu Biologics’ investigational new treatment, QBECO SSI, for Crohn’s disease. A maximum of 30 US patients will be allowed to participate in this Phase 1/2 Crohn’s disease research trial, located in Vancouver, Canada.

The main purpose of this study is to test whether this investigational treatment is safe and effective for the treatment of Crohn’s disease.

Prior to this formal clinical trial, ten patients with Crohn’s disease were treated with QBECO SSI in a compassionate use program. All ten patients reported improvement in symptoms while on SSI treatment. Seven of the ten patients reported full resolution of clinical symptoms with a course of SSI treatment of three months or more. Four of these patients have had sustained clinical remission after discontinuing all medications including SSI treatment.

The longest case of clinical remission reported is still ongoing after more than three and a half years. These previous ten patients were treated under a compassionate use program, not a controlled blinded clinical trial, and therefore these results do not provide proof of benefit.