Qu Biologics has received a ‘no objection letter’ (NOL) from Health Canada to commence a Phase II clinical trial of QBECO SSI for treatment of Crohn’s disease (CD).
The follow-on trial is expected to begin patient screening and enrolment at various clinical trial sites across Canada, including Vancouver, New Westminster, British Columbia, and Ontario.
It aims to determine the optimal time-point to evaluate QBECO SSI induction of mucosal healing and remission with QBECO treatment in adults with moderate-to-severe CD.
The trial will feature an initial open-label stage with 20 patients, who will receive the QBECO SSI therapy.
Qu Biologics Clinical Operations and Drug Development vice-president Jim Pankovich said: “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.”
QBECO SSI was previously evaluated in two clinical trials for CD and ulcerative colitis (UC).
The trials have demonstrated high response and remission rates in anti-TNFα naïve CD patients at the week eight and week 16 treatment time-points.
CD patients previously treated with anti-TNFα drugs also showed continuous improvement through week 16 and thus, week 16 and week 26 remission induction time-points will be assessed in the new study.
Among other results, the trials found a correlation between the identification of specific blood immune markers associated with innate immune activation, and gut mucosal healing with QBECO SSI response/remission in both CD and UC.
This suggests that these biomarkers could be used to forecast QBECO response in CD and UC.