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A quantitative model for metabolic intervention using gut microbes.

Zachary J S Mays1, Nikhil U Nair1

  • 1Department of Chemical & Biological Engineering, Tufts University, Medford, Massachusetts, USA.

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|January 11, 2021
PubMed
Summary

This study introduces a new model for evaluating living therapeutics, like engineered microbes, which are crucial for personalized medicine. The adapted compartmental absorption and transit (ALT-CAT) model helps assess their efficacy in patients with phenylketonuria (PKU).

Keywords:
advanced compartment and transit (ACAT)mathematical modelpharmacokinetics-pharmacodynamic (PK-PD)probiotics phenylketonuria (PKU)

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Area of Science:

  • Biotechnology and Pharmaceutical Sciences
  • Microbiology and Immunology
  • Genetics and Personalized Medicine

Background:

  • The rise of precision medicine necessitates novel therapeutic production methods, with microorganisms offering a viable solution for complex biomolecules.
  • Living therapeutics, particularly probiotic microbes engineered for oral delivery, represent a nascent but promising drug platform.
  • Existing pharmacokinetic-pharmacodynamic (PK-PD) models are inadequate for evaluating these novel living therapeutics.

Purpose of the Study:

  • To adapt traditional oral drug delivery models for the evaluation of living therapeutics.
  • To develop the Adapted for Living Therapeutics Compartmental Absorption and Transit (ALT-CAT) model.
  • To provide a framework for assessing the efficacy and informing the engineering of orally delivered microbial therapeutics.

Main Methods:

  • Adapted traditional oral drug delivery models to create the ALT-CAT model.
  • Utilized a late-stage clinical development case study of a living therapeutic for phenylketonuria (PKU).
  • Evaluated model parameters influenced by patient physiology, microbe selection, therapeutic production, and dosing formulations.

Main Results:

  • The ALT-CAT model provides efficacy metrics for living therapeutics across nine PKU patient age groups.
  • Identified key physiological and formulation parameters impacting the behavior of engineered bacteria as living therapeutics.
  • Demonstrated the mathematical framework for modeling orally delivered engineered bacteria using principles from small molecule drug delivery.

Conclusions:

  • The ALT-CAT model offers a suitable framework for evaluating orally administered living therapeutics.
  • This model is crucial for advancing the development and engineering of microbial-based drug pipelines.
  • The adapted model supports the transition of living therapeutics from research to clinical application, particularly for rare diseases like PKU.