US-based microbiome therapeutics platform company Seres Therapeutics has commenced the Phase Ib clinical trial of SER-262 to treat primary Clostridium difficile infection (CDI).
SER-262 is an Ecobiotic rationally-designed, fermented microbiome therapeutic, which is administered orally.
It is sythentically derived and requires no human donor material.
The capsule comprises a combination of 12 bacterial strains in spore form selected on the basis of criterion, which are human microbiome analysis, efficacy in animal models of CDI, and bacterial strain level characterisation.
Around 60 patients with CDI will be involved in the randomised, placebo-controlled, dose escalation Phase Ib trial, to be conducted over a period of 24 weeks.
The trial is primarily focused on comparing the CDI recurrence rate between the SER-262 and placebo groups after dosing them for eight weeks.
Seres president CEO and chairman Roger Pomerantz said: "The SER-262 programme has demonstrated our ability to rapidly develop a new class of synthetic microbiome therapeutics comprised of rationally designed bacterial compositions.
"We intend to continue to utilise our platform technology and unique knowledge of bioinformatics, microbiology, manufacturing and regulatory requirements to develop additional rationally designed microbiome therapeutics for serious diseases in each of our three therapeutic franchises: infectious disease, immunology and metabolic disease."
The company is currently also undertaking SER-109 Phase II trial to treat multiply recurrent CDI.
The initial study results from the SER-109 Phase II study are expected this year.
Image: Clostridium difficile occurrence on a blood agar plate. Photo: courtesy of CDC/Dr. Holdeman via Wikipedia.