QBECO SSI Efficacy & Safety
QBECO for the treatment of Crohn’s disease
With growing evidence that innate immune system dysfunction may underlie a variety of autoimmune diseases, Qu Biologics began treating patients with Crohn’s disease, ulcerative colitis and arthritis through a compassionate use program.
Ten (10) patients with uncontrolled persistent moderate-to-severe Crohn’s disease were treated with QBECO SSI treatment through the compassionate use program. Patients may have continued to receive conventional medical treatments and/or complementary therapies in addition to the 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.
- 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 3 years.
- Three of the seven patients reporting full remission had follow-up colonoscopies or CT scan with confirmation of full remission. Nine of the ten patients were able to discontinue all other medications at some point while on QBECO 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