Qu Biologics Inc., a biopharmaceutical company developing Site Specific Immunomodulators (SSIs), announced that the first patient of their Phase 1/2 clinical trial has been enrolled. Since the trial is just beginning, Qu Biologics is actively recruiting participants with moderate-to-severe Crohn’s disease.
“We are encouraged by the preliminary results of sustained remission of Crohn’s disease in some patients that were treated with QBECO SSI in a small compassionate use program and hope to achieve the same level of efficacy in this larger, controlled study,” said Dr. Hal Gunn, CEO of Qu Biologics. “QBECO SSI aims to stimulate the innate immune system to remove the underlying trigger for this disease and therefore, presents a possible new treatment option for people living with Crohn’s disease,” added Dr. Gunn.
Ten patients with Crohn’s disease were treated with QBECO SSI in a compassionate use program and all ten reported improvement in their symptoms while on the treatment. Seven of the ten patients reported a full resolution of their symptoms after a treatment period of three months or longer. Four of these seven have had sustained clinical remission after stopping all medications and treatment, including QBECO SSI. The longest case of remission has lasted three years and still continues. Three patients who reported clinical remission had follow-up colonoscopies that confirmed their reports. However, because these patients were part of a compassionate use program, their results do not provide proof of benefit.
A total of 121 patients with cancer and autoimmune disease have been treated with QBECO SSI therapy. QBECO SSI was well-tolerated with no serious adverse events reported.
Health Canada gave Qu Biologics a no objection letter to conduct a Phase 1/2 clinical trial of QBECO SSI to treat Crohn’s disease. Qu Biologics is recruiting 60 adults with active moderate-to-severe Crohn’s disease. With these participants, Qu Biologics will evaluate the efficacy of SSI in terms of clinical response and remission. The goal of the trial is to determine whether or not QBECO SSI is a safe and effective treatment for Crohn’s disease.
Further details on the clinical trial can be found here.