Clinical Trial Experience in Crohn’s disease

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Summary of results from Qu Biologics’ first clinical trial in Crohn’s disease

Qu Biologics has completed a Phase 1/2 randomized, placebo-controlled clinical trial to evaluate the use of investigational treatment QBECO for moderate-to-severe Crohn’s disease. Participants (total number 68) were randomized 1:1 to receive either QBECO (34 participants) or placebo (34 participants) for the first eight weeks of the study. At eight weeks, participants were assessed for improvement of disease activity. Those whose disease had improved continued their assigned blinded therapy (either QBECO or placebo) for another eight weeks (having a total of 16 weeks of study treatment), while all participants who had not yet responded to treatment were provided “open-label” QBECO for eight weeks. Subsequent to the 16 weeks of treatment, all participants were followed for an additional eight weeks to monitor for safety.

The objectives of this proof-of-concept study were two-fold: 1) to evaluate the safety profile of QBECO treatment and 2) to obtain an indication as to the therapeutic benefit of QBECO induction treatment on clinical improvement in patients with Crohn’s disease. Additional exploratory analyses were conducted to look for factors that may potentially predict response to QBECO treatment, which included: 1) prior or concomitant use of immune suppressive therapies for Crohn’s disease; 2) participants’ genetics ; and 3) serum immune biomarkers.

The high-level results are as follows:

1. QBECO appears to be safe and well-tolerated

2. QBECO treatment was associated with consistently positive trends in response , improvement and remission throughout the treatment period of the trial, establishing proof-of-concept in the treatment of participants with Crohn’s disease

With further analysis, several important additional findings emerged:

1. High response and remission rates observed in anti-TNFα naïve patients

In participants who had never received anti-TNFα therapy, treatment with QBECO for eight (8) weeks resulted in a statistically significant response rate1 of 64%, compared to 27% in the placebo control group (p=0.041). Clinical remission rates3 after eight (8) weeks of treatment were 50% in the QBECO treatment group, versus 23% in the placebo control group (p=0.16)

2. Immune biomarkers may predict response to QBECO therapy

Specific blood immune markers associated with immune activation and mucosal healing were found to be increased with QBECO treatment and QBECO response/remission.

3. Genetic profile may predict treatment outcome

Genetic analyses of trial participants identified common IBD-related genotypes with a higher likelihood of response to QBECO. This suggests that for the first time it may be possible to personalize treatment for CD. Early indications support the idea that genetic testing may be able to identify a large subset of individuals living with CD (representing approximately 60% of the patient population) who have a greater than 90% likelihood of responding to QBECO treatment.

Taken together, the data from Qu Biologics’ first clinical trial in Crohn’s disease greatly improves our understanding of QBECO treatment in this important indication and provides evidence that it may be possible to select patients most likely to benefit from this novel immunotherapy approach. These results strongly support continued development of QBECO for the treatment of Crohn’s disease and an alternative to the immunosuppressive regimen currently used to manage disease. A follow-on trial is currently being planned, and it is anticipated that enrollment will commence in the first quarter of 2018.

If you are interested in participating in and receiving updates about future clinical trials in Crohn’s disease evaluating QBECO for IBD, please email info@qucrohnstrial.com indicating your request.