QBECO SSI Efficacy & Safety

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QBECO for the treatment of Crohn’s disease

With growing evidence that immune system dysfunction may underlie a variety of immune-related diseases, Qu Biologics began treating patients with Crohn’s disease, ulcerative colitis and arthritis through a compassionate use program.

Initial results from Crohn’s disease clinical trial

Based on the Week 8 and Week 16 results, QBECO SSI appears safe and well-tolerated and demonstrates 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.

Clinical data from compassionate use programs provide precedent for current studies

Results from the compassionate use program involving ten patients with Crohn’s disease treated with QBECO SSI were published in Gastroenterology Research and Practice. A copy of this journal article can be found here. The QBECO SSI compassionate use results were also presented in a scientific poster at Digestive Diseases Week 2014.  Download a copy here.

Ten (10) patients with uncontrolled persistent moderate-to-severe Crohn’s disease and two patients with moderate to severe ulcerative colitis were treated with Qu Biologics’ QBECO SSI through the compassionate use program. Patients may have continued to receive conventional medical treatments and/or complementary therapies in addition to the SSI treatment.

Crohn’s disease

  • Ten of ten patients reported improvement in clinical symptoms.
  • Eight of the ten patients were able to discontinue all other medications at some point while on QBECO SSI treatment.
  • Seven of the ten patients reported full resolution of clinical symptoms with a course of QBECO SSI treatment of three months or more.
  • Three of these patients are in ongoing sustained clinical remission after discontinuing all medications including SSI treatment.
  • Ongoing sustained clinical remission in these three patients is continuing since August 2010, August 2011 and March 2012, respectively.
  • All three patients in ongoing sustained remission have had follow-up colonoscopies or imaging confirming remission.

Ulcerative colitis

  • Both patients noticed improvement in symptoms (i.e., reduced bowel movement frequency, reduced urgency, and reduction of blood in stool).
  • Both patients had full resolution of symptoms and were able to discontinue all medications including SSI treatment.
  • Both patients are in ongoing sustained remission, off all medications (more than 4 years after starting SSI treatment)

It is important to note that data collected were neither placebo-controlled nor ‘blinded’ to the physician or patient. Accordingly, they represent a prospectively-acquired, cumulative, preliminary experience from which proof of benefit of QBECO SSI treatment cannot be established. However, these observations are sufficiently promising to warrant the conduct of a prospective, randomized, placebo-controlled, double-blinded clinical study of QBECO SSI treatment versus placebo in patients with active, moderate to severe Crohn’s disease.

Safety profile of QBECO in Crohn’s disease

A total of 122 patients received QBECO SSI, the investigational treatment in the current clinical trial in Crohn’s disease: 109 patients with advanced cancer, ten (10) with Crohn’s disease, two (2) with ulcerative colitis, and one (1) with a non-autoimmune bowel condition.

With a maximum follow-up period of over 30 months, no treatment-related serious adverse events have been observed or reported to date. The only reported treatment-related adverse events associated with study treatment have been transient fever in three patients which resolved without required treatment within 12 – 18 hours and a larger than anticipated transient local skin immune response to initial treatment dose, which was corrected with appropriate subsequent dose reduction.

It is important to note that data collected were neither placebo-controlled nor ‘blinded’ to the physician or patient. Accordingly, they represent a prospectively-acquired, cumulative, preliminary experience from which proof of safety of QBECO cannot be established. However, these observations are sufficiently promising to warrant the conduct of a prospective, randomized, placebo-controlled, double-blinded clinical study of QBECO versus placebo in patients with active, moderate-to-severe Crohn’s disease.

Ease of administration of QBECO

Persons receiving SSI treatment are trained by a qualified health professional to self-administer the SSI treatment. SSI treatment is given every second day by subcutaneous injection. Subcutaneous injection is a simple injection method – the injection method commonly used for self-administration (e.g., insulin injections for the treatment of diabetes). A short, small needle is inserted just under the skin and the SSI is injected (almost painless). The injection itself takes less than one minute.

Learn how SSI treatment is administered