Writing in Frontiers in Microbiology, the team presents The Microbiome Health Index for post-Antibiotic dysbiosis (MHI-A), an algorithm that calculates levels of beneficial bacteria such as Bacteroidia and Clostridia versus ‘harmful’ bacteria such as Gammaproteobacteria and Bacilli.
The study team, aided by colleagues from Rebiotix, shows MHI-A ability to distinguish post-antibiotic dysbiosis from healthy microbiota.
MHI-A values were consistent across healthy populations and were significantly shifted by antibiotic treatments known to alter microbiota compositions and shifted less by microbiota-sparing antibiotics.
The research team suggests MHI-A may also be useful for ranking the microbiota-disrupting effects of antibiotics and as a measure of microbiota restoration.
Concise metric
“This biomarker provides a concise metric for assessing the complex changes in the microbiome of trial participants pre- to post-treatment, expanding our understanding of microbiome restoration after antibiotic use,” explains lead author Ken Blount, Chief Scientific Officer, Rebiotix,
“This is a crucial step in unlocking the potential of microbiome-based live biotherapeutics, further demonstrating Ferring’s leadership in advanced research that addresses the urgent needs of patients with recurrent C. diff,” adds Blount, who is also Vice President of Microbiome Research at Rebiotix’s parent company Ferring.
MHI-A was developed using data from over 200 patients treated with Ferring’s two microbiome-based live biotherapeutic (LBP) products RBX2660 and RBX7455 to treat recurrent C. difficile infection (CDI).
By comparing the algorithm findings against baseline post-antibiotic dysbiosis samples, the team concluded that MHI-A values were consistent across a range of healthy populations.
The scientists also observed that responses to RBX2660 and RBX7455 were linked to a shift of MHI-A from dysbiotic values to healthy representations.
By ranking antibiotic impact on the microbiota, the team suggests this would be useful in the development of more microbiota-sparing antibiotics as well as identifying patients at risk of dysbiosis-related complications.
RBX2660 has the potential to be a first-in-class microbiota-based live biotherapeutic capable of delivering specific microbes to the gut to reduce recurrent C. difficile infection.
C. difficile efforts
It is one of a number of candidates currently undergoing testing as a therapeutic for C. difficile infection as both pharmaceutical and nutrition-based firms continue to delve into the microbiome as a basis to tackle other conditions such as Irritable Bowel Syndrome (IBS) and Crohn’s disease.
Bacthera, the joint venture between Chr. Hansen and Lonza, teamed up with Seres Therapeutics in November 2021, to manufacture Seres’ lead product candidate for recurrent CDI.
The deal will expand Seres’ manufacturing capabilities for SER-109, an oral microbiome therapeutic containing Firmicutes spores, which normally live in the healthy microbiome.
SER-109 is designed to prevent rCDI by modulating the disrupted microbiome to resist C. difficile colonisation and growth.
In June of last year, NovoBiome and The French National Research Institute for Agriculture, Food and Environment (INRAE) inked their second research partnership, having worked on developing an LBP drug candidate targeting Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steato-Hepatitis (NASH).
The investment unit of healthcare giants Bayer invested €14m ($17m) in biotech firm Azitra to develop LBPs that address skin disorders like atopic dermatitis and acne.
The funding round, completed in October 2020, built on an existing agreement formed in January of that year, where the two firms worked on identifying candidates from a panel of Staphylococcus epidermidis strains to tackle skin conditions and diseases.
Source: Front. Microbiol.
Published online: doi: 10.3389/fmicb.2021.781275
“Development and Validation of a Novel Microbiome-Based Biomarker of Post-antibiotic Dysbiosis and Subsequent Restoration.”
Authors: Ken Blount et al.
Join Ferring's Kristin Wannerberger, at this year's Probiota as she guides us through a case study that taps into the firm's focus on live biotherapeutics and the emergence of pharmabiotics.
Held on 23-25 February in Copenhagen, Probiota bridges the gaps between science, business, and regulatory developments in the microbiome, probiotic and prebiotic markets.
For more information and to register, please click HERE.
