Case study – Novonesis

De-risking Clinical Trial Design With Advanced Cohort Stratification
How PIPA identified biomarkers and mechanistic insights to strengthen trial design for CDI and IBS.

Novozymes One Health (Novonesis) partnered  with PIPA to reduce clinical trial risk for Clostridium difficile infection (CDI) and Irritable Bowel Syndrome (IBS). The goal was to identify microbes, biomarkers, mechanisms of action, and comorbidities that could guide cohort stratification, and support the likelihood of trial success.

Integrated Multi-Omics and Knowledge Analysis

Using LEAP, PIPA combined raw 16S and RNA-seq data with biomedical literature and curated databases. The integrated analysis generated a comprehensive view of disease progression, microbial drivers, molecular pathways, and potential therapeutic leverage points.

Results

The work reduced clinical trial risk by translating complex multi-omics data into clear, actionable guidance for targeting different mechanisms of action,  selecting the most appropriate cohorts, and selecting biomarkers.

Highlights
Microbial targets (300+) characterized across distinct stages of disease, supporting stage-specific hypotheses and intervention strategies
Integrated molecular evidence connecting hundreds of compounds, genes, & pathways to underlying disease biology, strengthening mechanistic confidence
Clinically meaningful comorbidities & treatment signals identified to inform cohort stratification & reduce confounding factors in downstream studies
A perspective from the Novozymes team

At Novozymes One Health, our mission is to discover natural health solutions such as enzymes and probiotics that will guard people against disease and enhance people’s wellbeing. PIPA has joined us in this journey, enabling our R&D and business teams to leverage data in smart and actionable ways to uncover insights that lead to unique “one-in-a-trillion” product offerings.

Dr. Kimmo Makinen, Director of Innovation, One Health, Novozymes (2022)

Technologies

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