Investigational QBECO SSI Therapy Enters Phase 2 Clinical Trial for Crohn’s

Investigational QBECO SSI Therapy Enters Phase 2 Clinical Trial for Crohn’s

Qu Biologics soon will begin recruiting participants for a Phase 2 clinical trial to continue investigating the company’s special platform of immunotherapies, collectively called Site Specific Immunomodulators (SSIs), as a potential therapy for Crohn’s disease.

Patients’ enrollment will open soon in five clinical trial sites throughout Canada, first in Vancouver and New Westminster, followed by Vernon, British Columbia and Hamilton, Ontario. More information on the trial and enrollment requirements is available here.

The investigational QBECO SSI therapy was designed to restore the body’s normal immune function in cancer and immune-related diseases, such as Crohn’s disease.

In a previous Phase 1/2, placebo-controlled study (NCT01809275), 68 adult patients with moderate-to-severe Crohn’s disease were randomized to either take QBECO SSI or placebo for eight weeks. Those who responded to treatment continued the therapy — QBECO or placebo — for another eight weeks. Those who failed to respond went on an “open-label” regiment with QBECO treatment for the next eight weeks.

The results showed that 50% of the patients achieved clinical remission after being treated for eight weeks with QBECO-SSI, compared to 23% of patients treated with placebo. About 40% of patients who had previously received anti-TNF-alpha therapies were in remission by the end of the 16 weeks of treatment. In this trial, remission was defined as a Crohn’s Disease Activity Index (CDAI) score below 150 points.

In the QBECO SSI Phase 2 trial (NCT02426372) that tested QBECO SSI in a small population of patients with moderate-to-severe ulcerative colitis, the results showed that after the 16 weeks of treatment, 73% of the patients achieved a significant clinical response and 45% presented endoscopic healing.

The levels of biomarkers of innate immune activation and gut mucosal healing helped predict the response to QBECO SSI in IBD, the trial showed. Additionally, the trial showed that response to treatment associated with specific ulcerative colitis-related mutations, supporting a potential for personalized medicine strategies.

This Phase 2 study (NCT03472690) aims to recruit 170 participants with moderate-to-severe Crohn’s disease to further establish the QBECO SSI’s safety and effectiveness.

The study will be conducted in three stages — lead-in, main induction and main maintenance phases. The lead-in phase is an open-label stage, meaning that all enrolled participants (20) will receive QBECO SSI therapy up to 26 weeks. The aim is to determine whether longer treatment leads to better endoscopic healing outcomes compared to the previous regimen of 16 weeks.

The main induction phase (150 participants) will randomize patients to QBECO SSI therapy or placebo to assess the effect of QBECO SSI on clinical remission, measured by abdominal pain and soft-stool frequency at the end of the treatment.

Participants meeting response criteria following the main induction phase can continue into the main maintenance phase of the study, where they’ll keep undergoing their initially randomized treatment. The objective is to assess the QBECO SSI effects on clinical remission after 52 weeks of treatment.

Trial results are expected by April 30, 2019.

“We are excited to initiate our next important study in Crohn’s disease to confirm the potentially transformative findings of our last study and to prepare the way for future pivotal studies in Crohn’s disease,”  Hal Gunn, Qu’s CEO, said in a press release.

“Unlike current CD treatments that suppress immune function, QBECO SSI is designed to restore immune function. As such, rather than treating the end result of the disease, we believe that our novel approach, that addresses the underlying cause of the disease, could change the way this challenging disease is treated,” said Jim Pankovich, Qu Biologics vice president, Clinical Operations & Drug Development.