Patients with Crohn’s disease benefit from treatment with a new platform of immunotherapies designed to restore the body’s innate immune system, a study has found. The announcement was made by Qu Biologics, the company behind the Site Specific Immunomodulators (SSIs).
SSIs are a platform of immunotherapies obtained from components of bacteria and are designed to treat cancer and other immune-related diseases, like ulcerative colitis and Crohn’s disease, by stimulating the body’s immune system. Qu Biologics has advanced multiple SSIs, each of which targets a specific organ or tissue.
The company recently completed a clinical trial on its QBECO SSI as a therapeutic approach for Crohn’s disease. The Phase 1/2 placebo-controlled, double-blind study included 68 adult patients with moderate-to-severe Crohn’s disease.
Patients were randomized to either QBECO SSI or placebo for the first eight weeks of the study. Participants who responded to treatment continued their therapy for another eight weeks, while those who failed to respond were provided with an “open-label” QBECO treatment for the next eight weeks.
Results reported by Qu Biologics show that after eight weeks of treatment with QBECO SSI, 64% of patients had a statistically significant response, compared to 27% of patients treated with a placebo.
Half of patients, or 50%, achieved clinical remission after being treated for eight weeks, while only 23% of patients treated with a placebo reached this goal.
Clinical response and remission rates were measured with the Crohn’s Disease Activity Index (CDAI), where clinical response is defined as a decrease in CDAI of more than 70 points, while remission means that patients reached a CDAI score of less than 150 points.
“In patients previously treated with TNFα inhibitors who completed 16 weeks of SSI treatment, 40% were in remission, suggesting that this more challenging patient group may respond to QBECO SSI with longer treatment,” Jim Pankovich, Qu Biologics’ vice president of clinical operations and drug development, said in a press release.
“Remission rates in similarly designed randomized placebo controlled trials with current ‘gold-standard’ treatments for [Crohn’s disease], Remicade and Humira, are approximately 35% in anti-TNFα naïve patients at similar time-points, so the 50% remission rate in this important patient group in this trial is promising,” said lead researcher Brian Bressler, University of British Columbia clinical assistant professor of medicine in the gastroenterology division.
Anti-TNFα naïve patients are those who have not been treated with the immunosuppressive drugs like Remicade, Humira, Cimzia and Simponi. Patients who have been treated with these drugs and have failed to respond to the treatment are considered a difficult-to-treat patient population.
Based on the study’s cytokine analysis, Qu Biologics said that patients who had been treated with anti-TNFα drugs may have greater baseline innate immune suppression/dysregulation and may benefit from a longer treatment period.
“We are pleased with the high response and remission rates in the QBECO-treated anti-TNFα naïve CD patients at the early Week 8 time-point,” said Dr. Hal Gunn, CEO of Qu Biologics, “particularly as data from the trial suggests that many patients continue to improve on SSI treatment after this time-point. Future studies will assess response and remission rates with longer treatment periods.”
The company is expecting to start a larger follow-on clinical trial in patients with Crohn’s disease by early next year, where it will evaluate QBECO SSI for a treatment period of 52 weeks.
“When this data is combined with the genetic and cytokine biomarker data from the trial, it suggests that we may be able to select patient groups with an even higher probability of response and remission with QBECO SSI treatment. These results are very encouraging and will guide us in the design of our next study and in future Phase 3 studies,” Gunn said.
In addition to Crohn’s, the company is testing its SSIs to treat ulcerative colitis and recurrent lung cancer.