Clinical Trial Experience in Ulcerative Colitis

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Summary of results from Qu Biologics’ first clinical trial in ulcerative colitis

Qu Biologics has completed an open-label, dose-ranging, proof-of-concept clinical trial to evaluate the safety, tolerability and efficacy of QBECO for the treatment of patients with moderate-to-severe ulcerative colitis. An important aim of the trial was to capture objective measures of changes in disease activity, which included both endoscopic and histological assessment, with QBECO treatment.

The key primary and secondary objectives of this study were: 1) to evaluate the safety and tolerability profile of QBECO treatment at three (3) fixed doses; and 2) to evaluate the therapeutic benefit of QBECO treatment on clinical remission during and at the end of treatment; and 3) to evaluate the effect of QBECO treatment on endoscopic healing during and at the end of treatment. Additional exploratory analyses were conducted to look for factors that may potentially predict response to QBECO treatment, which included: 1) participants’ genetic background; and 2) serum immune biomarkers.

The high-level results are as follows:

1. QBECO was found to be safe and well-tolerated by the study participants;
2. QBECO SSI treatment was associated with consistently positive trends in response and remission within the first 16 weeks of the trial, establishing proof-of-concept in ulcerative colitis

With further analysis, several important additional findings emerged:

1. High clinical and endoscopic response and remission rates within first 16 weeks of treatment
In the open-label clinical trial, eight of 11 (73%) of participants treated with QBECO achieved clinical response and five participants (45%) had evidence of endoscopic healing within the first 16 weeks of treatment. One participant attained clinical and endoscopic remission by study week 8. Histological improvement occurred in six of 11 (55%) of trial participants, including six of eight (75%) participants who responded to treatment.
2. Genetic biomarkers may predict response to QBECO therapy
Genetic analyses found that response to QBECO treatment was associated with specific ulcerative colitis-related variants in regions of the genome close to genes of high relevance to QBECO’s mechanism of action, i.e., genes involved in the activation of innate immune function and clearance of bacterial infection/dysbiosis.
Taken together, data from Qu Biologics’ first clinical trial in ulcerative colitis contributes to our understanding of QBECO treatment and, potentially, suggests that it may be possible to identify specific populations of individuals who will most benefit from QBECO treatment. These results support continued development of QBECO for the treatment of ulcerative colitis.

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