Home The Gut Microbiome can influence the outcome of your clinical trial

The Gut Microbiome as a Source of variable Drug Response

Let us help you control this variable!

Identification of Microbial Biomarkers

Components of the microbiome, such as specific bacteria or bacterial genes, holds great potential as predictive biomarkers. The predictive ability of the microbiome is being tested for a range of drugs, from immune checkpoint inhibitors in cancer to immune-suppressors in inflammatory disorders. Bringing microbial biomarkers forward for clinical application as companion diagnostics fuels the inevitable move of the pharmaceutical field towards personalized treatment.

 

“To date, microbial strainsand enzymes have been experimentally demonstrated to directly or indirectly
impact the metabolism and efficacy of over 50 therapeutic
drugs, driving inter-patient variability in drug activation, inactivation
and toxicity”  (Guthrie and Kelly, 2019)

 

In BiomCare we perform Microbial Biomarker Detection, using Next Generation Sequencing data from fecal samples processed using our in-house biostatistical workflow. The analysis results in a list of ranked predictive biomarkers, and estimation of the predictive ability of the microbial biomarkers.

How can a gut microbiome analysis improve the success rate of your clinical trial?

Analysis of the gut microbiome is increasingly becoming a part of clinical testing of pharmacological products. And for a good reason: The human microbiome is personal – with high diversity between people and reasonably high stability within a person over time – and highly involved in drug metabolism.

By analyzing the gut microbiome profile of patients in the trial, BiomCare can assess:

  • How important the gut microbiome is for drug response,
  • Identify microbial bomarkers
  • Calculate how well the biomarkers predict drug response (e.g. separate high, low or non-responders)

By incorporating the results from BiomCare’s analysis into your trial statistical analysis, you can learn if the microbiome is a key driver of varying drug response and how it influences your efficacy profile. By statistically stratifying participants retrospectivly into high and low responders using the multimarker model developed by BiomCare, you learn if efficacy is dependent on microbiome profiles. This can improve your power and confidence in your results and provide further understanding of physiological drug mechanisms.

Altogether, incorporating the gut microbiome analysis into your clinical trial holds the potential af increased control, reduced risk due to varying drug response. This can facilitate co-deveopment of companion disgnoastics and improve the competitive abilities of your drug on the market.

What BiomCare needs from you?

If you are planning or currently undertaking a clinical trial of a compound that might be influenced by the gut microbiome, we would like to hear from you. Such a drug is likely orally ingested, might depend on or effect the physiological structures, cells, metabolites or hormones that are linked to the gut microbiome. Alternatively, the drug might be known to have variable drug response not explained by human genetics.

 

If you decide to collaborate with BiomCare we only need two things from you during the trial:

  1. A stool sample from each study participant before the drug is administered. BiomCare provides you with a stool collection kit that include all instructions and an envelope with return address. After stool collection, the participants simply need to put the kit into the nearest postbox.
  2. Clinical data on the observed drug response, together with a few additional phenotypic variables such as age, gender and BMI. The data must have an ID that can link the clinical data with the stool samples. BiomCare does not otherwise need person-identifying information.

1) Doherty et al, 2017; Guthrie et al, 2017; Ananthakrishnan et al., 2017; Zimmermann et al., 2019