A summary of the initial Week 8 results are available. Check the Crohn's disease clinical trial page of this website to learn more.
Enrollment into this clinical trial has completed and we are no longer accepting new participants. If you are interested in receiving updates about a future clinical trial in Crohn’s disease involving Qu Biologics’ Site Specific Immunomodulators (SSIs), please email email@example.com indicating your request.
Qu Biologics is planning to initiate a multi-site clinical trial to study QBECO SSI for Crohn's disease, based on results from the latest Phase 1/2 clinical trial in Crohn's disease. We expect to have more details about the timing of this trial by December 2017. Anyone interested in being notified of a future clinical trial in Crohn's disease may email us at firstname.lastname@example.org indicating your request.
The mechanism of action of SSI has not yet been elucidated. Preliminary preclinical research conducted by Qu Biologics suggests that QBECO SSI acts to stimulate the innate immune system in a site-specific (i.e., organ/tissue specific) manner, and in particular, to stimulate the recruitment of specific immune cells to the site of disease, i.e., the bowel. Studies are currently underway to explore this hypothesis further.
Ten people with moderate to severe Crohn’s disease uncontrolled with standard treatment have been treated with QBECO to date. All 10 had improvement in symptoms. 7 of the 10 went into remission while on treatment and 3 of those people are in sustained remission after stopping all medications including QBECO SSI. The longest remission is ongoing since July 2010 (discontinued all treatment, including SSI treatment, since July 2011).
Based on the Week 8 and Week 16 results, QBECO SSI appears safe and well-tolerated and demonstrated consistently positive trends throughout the treatment period of the trial, successfully establishing proof-of-concept in Crohn’s disease and supporting continued development of QBECO SSI in inflammatory bowel disease.
In more than 250 participants treated with SSIs who have been followed for a maximum of four years, no serious adverse events have been observed or reported. A small number of patients reported larger than anticipated transient injection site reactions (including one or more of the following symptoms: increased redness, tenderness, induration, painful induration), and/or mild flu-like symptoms (including one or more of the following symptoms: fever, muscle aches, physical discomfort, cough). All of these symptoms were reported to resolve within a few days without any requirement for treatment.