Synthetic Biologics and Enterome Bioscience to study impact of beta-lactam
antibiotics on intestinal bacteria
10 June 2014
Antibiotics developer Synthetic Biologics and gut microbiome
specialist Enterome Bioscience SA have announced they will
collaborate in metagenomic research on the effects of beta-lactam
antibiotics on the gastrointestinal microflora of human patients.
As part of this collaboration, a clinical microbiome study of
approximately 100 patients is expected to begin in July this year.
Research findings should provide important insights as Synthetic
Biologics advances the development of SYN-004, which is intended to
protect the gut microbiome from the effects of intravenous (IV)
beta-lactam antibiotics, and in particular to prevent C. difficile
(C. diff) infections. Phase Ia and Ib clinical trials of Synthetic
Biologics’ SYN-004 are scheduled to begin later this year.
The Enterome microbiome study, scheduled for completion in the
second half of 2014, is expected to provide a better understanding
of the harmful effects of beta-lactam antibiotics on the gut
bacterial community. The goal is to establish a “fingerprint” of the
damage caused by beta-lactam antibiotics, thus yielding a panel of
bacterial biomarkers that can be leveraged for diagnostic purposes.
This novel study should clearly define the impact of beta-lactam
antibiotics on the natural bacterial diversity of the gut microbiome.
Changes in the gut microbiome have been related to multiple
diseases, including C. diff infections,
antibiotic-associated diarrhoea, obesity, diabetes and other
metabolic diseases. This study will utilize Enterome’s
state-of-the-art shotgun metagenomic sequencing technology to
profile the human gut microbiome.
“We are pleased to establish this collaboration with Enterome, a
pioneer in the development of biomarkers and therapies for diseases
of the gut microbiome,” stated Jeffrey Riley, CEO of Synthetic
Biologics. “Findings from this study should support our C. diff
therapeutic program, which focuses on protecting and maintaining the
balance of bacterial microflora in the gut, while also establishing
our presence in Europe.”
Synthetic Biologics’ lead anti-infective product candidate,
SYN-004, is the first therapy designed to neutralize IV antibiotics
in the gut, and is intended to protect and maintain the balance of
bacterial flora in the gastrointestinal tract, to prevent the
devastating effects of C. diff.
The US Centers for Disease Control and Prevention (CDC) has
classified C. diff as an “urgent public health threat”
surpassing MRSA as the number one hospital-acquired infection in the
United States. C. diff is a multidrug-resistant bacterium
that is estimated to infect 1.1 million US patients annually and
lead to an estimated 3.6-7 extra days in hospital.
“The signing of this agreement with Synthetic Biologics is
another important corporate milestone for Enterome. I am very
pleased that our pioneering approach to understanding the linkage
between changes in the gut microbiome and disease has convinced
Synthetic Biologics to work with us on such an important
personalized medicine project. It is clear that new diagnostic
solutions are needed to properly address the growing problem of
antibiotic-induced dysbiosis and associated hospital-acquired
bacterial infections,” said Pierre Belichard, CEO of Enterome.
“Tailoring the use of anti-infective treatments based on microbiome
profiling is beginning to show great promise as a way to address the
management of infectious diseases.”
About SYN-004 Clinical Development
Synthetic Biologics is developing SYN-004, a novel second
generation oral enzyme drug candidate, to be co-administered with
commonly used IV beta-lactam antibiotics and is intended to protect
the gastrointestinal microflora (microbiome) from the harmful
effects of such antibiotics, thus potentially preventing C. diff
The company says the planned next steps for SYN-004 include: 1)
initiation of a 28-day bridging toxicology study in June 2014; 2)
filing of an Investigational New Drug (IND) application to initiate
Phase Ia and Ib clinical trials in the second half of 2014, with
preliminary topline data expected by year-end 2014; and, 3)
initiation of a Phase II efficacy study is expected to begin in the
first half of 2015.
Source: Synthetic Biologics, Inc, Enterome Bioscience SA