Synthetic Biologics has dosed the first patient in a Phase Ia clinical trial of SYN-004, an investigational oral beta-lactamase enzyme, to preventi Clostridium difficile (C. difficile) infection (CDI), antibiotic-associated diarrhea (AAD) and secondary antibiotic-resistant infections.
Claimed to be the first and only treatment intended to prevent the development of C. difficile infection, SYN-004 has been designed to be able to bind with and neutralise certain common intravenous (IV) beta-lactam antibiotics in the gut.
SYN-004 blocks the unintended harmful effects of antibiotics within the gastrointestinal (GI) tract, maintaining the natural balance of the bacterial flora (gut microbiome).
Currently underway at Miami's Clinical Pharmacology, the randomised, double-blind and placebo-controlled Phase Ia study will evaluate SYN-004 in patients receiving IV beta-lactam antibiotic therapy.
The study has been designed to evaluate the safety, tolerability and pharmacokinetics of five single-ascending doses of oral SYN-004 in healthy volunteers.
According to the company, up to 40 healthy adult volunteers will be enrolled into five cohorts and about six participants will receive SYN-004, while two will receive placebo in each cohort.
Topline Phase I data is expected to be reported before 2014-end, and a Phase Ib study evaluating multiple-ascending doses of SYN-004 is slated for commencement.
Synthetic Biologics chief executive officer Jeffrey Riley said: "The initiation of the clinical programme for SYN-004 represents an important milestone for Synthetic Biologics and a key step towards the first potential point-of-care preventative therapy for C. difficile, the CDC's top-ranking public health threat.
"We look forward to moving Synthetic Biologics' innovative therapeutic approach to prevent C. difficile infection through clinical development, and further validating the connection between protecting the gut microbiome and a variety of GI, metabolic and CNS disorders."
So far, the US Food and Drug Administration (FDA) had not approved any vaccine or drug for the prevention of C. difficile infection specifically.
The US Centers for Disease Control (CDC) has identified C. difficile infection as an 'urgent public health threat.' It occurs mostly in people who have had recent medical care with IV antibiotics, which can create a harmful imbalance in the gut microbiome by killing good bacteria.