Rebiotix today unveiled its Microbiome Health Index – a tool it created to establish a standard metric that can be used to quantify how effective a microbiome-based therapy is at rehabilitating the human microbiome.
The index, which was developed in partnership with data analytics firm BioRankings, combines four bacterial classes into a unidimensional expression of change, according to Rebiotix.
The company used microbiome profiles of patients from a Phase IIb study of its microbiota-based drug to show that MHI can differentiate between patients with dysbiosis and patients with healthier microbiomes.
“In developing the Microbiome Health Index, our aim is to provide an objective, universal tool to measure the restoration of a dysbiotic microbiome across different trial designs, sequencing methods and across multiple drug technologies,” Ken Blount, Rebiotix’s chief scientific officer, said in prepared remarks.
“Initial analyses using MHI in Clostridium difficile infections have demonstrated its significant potential to quantify and differentiate dysbiotic from healthier microbiomes. As presented at ACG2017, MHI was able to quantify the relationship between four key bacterial classes into a single metric that can distinguish patients with dysbiosis resulting from C. diff. From this, we were able to gain valuable insight into the mechanism of action by which Rebiotix’s Phase III microbiota drug, RBX2660, is able to rehabilitate a dysbiotic microbiome to a healthier state.”
Blount also noted that the company is using MHI to analyze microbiome profile data collected from an ongoing Phase I trial of its lyophilized, non-frozen oral capsule microbiota-based drug.
“The human microbiome is a new frontier where very little analytical methodology or rigorous statistical methods have been developed specifically for this type of data,” Bill Shannon, co-founder & managing partner of analytics at BioRankings, added.
“Analytical tools such as MHI will be critical to advance translational clinical microbiome research, and we are emboldened by the MHI data that have been reported and continuing to be collected. Our vision is for MHI to become a standard measure for microbiome research, potentially serving as a validated endpoint for clinical trials and providing both a predictive measure and actionable data.”