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Related Experiment Videos

Novel Microbial-Based Immunotherapy Approach for Crohn's Disease.

Simon Sutcliffe1, Shirin Kalyan1,2, Jim Pankovich1

  • 1Qu Biologics Inc., Vancouver, BC, Canada.

Frontiers in Medicine
|August 6, 2019
PubMed
Summary

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This summary is machine-generated.

A novel immunotherapy, QBECO, shows promise for Crohn's disease (CD) by restoring immune function. This study found QBECO to be safe and effective in improving CD symptoms, suggesting potential for personalized treatment.

Area of Science:

  • Immunotherapy
  • Gastroenterology
  • Microbiome research

Background:

  • Current Crohn's disease (CD) treatments suppress immunity, risking infection and cancer, yet often fail to halt disease progression.
  • A need exists for novel CD therapies that improve patient outcomes by restoring immune function.
  • QBECO, a microbial-derived immunotherapy, is being investigated as a new approach.

Purpose of the Study:

  • To evaluate the safety, efficacy, and tolerability of QBECO in patients with moderate-to-severe CD.
  • To assess QBECO's potential to restore immune function, unlike current immunosuppressive therapies.
  • To explore immune biomarkers and genetic factors influencing QBECO response.

Main Methods:

  • A randomized, double-blind, placebo-controlled trial involving 68 moderate-to-severe CD patients.
Keywords:
Crohn's diseasebiologicbiomarkersimmunotherapyinnate immunitymicrobial-based therapyrandomized placebo-controlled trial

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  • Primary endpoints included safety and clinical improvement at Week 8.
  • Secondary endpoints assessed clinical response and remission at Week 8, with extended treatment for responders and non-responders.

    • Main Results:

    • QBECO demonstrated good tolerability.
    • Significant mean reduction in Crohn's Disease Activity Index (CDAI) score at Week 8 (-68 for QBECO vs. -31 for placebo), with continued improvement to Week 16 (-130 CDAI reduction).
    • Week 8 clinical response, improvement, and remission rates were higher with QBECO (41.2%, 32.4%, 29.4%) compared to placebo (26.5%, 23.5%, 23.5%). Higher response rates (64%) were observed in TNFα inhibitor-naïve patients treated with QBECO.

    Conclusions:

    • This proof-of-concept study supports QBECO as a potential novel immunotherapy for CD.
    • Biomarker analysis suggests personalized treatment strategies with QBECO may be feasible.
    • Larger clinical trials are warranted to confirm these findings and explore biological mechanisms.