Synthetic Biologics, Inc., a clinical stage company focused on developing therapeutics to protect the gut microbiome, announced that the US Patent and Trademark Office (USPTO) issued Notices of Allowance for three patent applications which cover composition of matter claims and methods of protecting the gut microbiome from certain beta-lactam antibiotics for the prevention of C. difficile infection (CDI) and antibiotic-associated diarrhoea (AAD). These new allowances further strengthen the company's novel proprietary candidate, SYN-004, which is also covered by a composition of matter patent in the US.

SYN-004 is designed to degrade certain intravenous (IV) beta-lactam antibiotics excreted into the gastrointestinal (GI) tract to maintain the natural balance of the gut microbiome. C. difficile is associated with approximately 453,000 CDIs and > 29,000 C. difficile-related deaths in the United States each year. Upon issuance, these newly allowed applications reinforce Synthetic Biologics' extensive C. difficile-related patent estate, which includes approximately 35 US and foreign patents and approximately 30 US and foreign patent applications, and carry patent terms that extend from at least 2031 to 2035.

"These new patents will complement our growing SYN-004 patent estate and support our C. difficile prevention programme, including two ongoing phase 2 clinical trials," said Jeffrey Riley, president and chief executive officer of Synthetic Biologics. "We're on schedule with respect to patient enrollment in our global phase 2b proof-of-concept clinical trial intended to evaluate the ability of SYN-004 to prevent CDI and AAD in patients hospitalized with a lower-respiratory tract infection. During the first half of 2016, we also anticipate announcing topline data from the second phase 2a clinical trial which is evaluating the ability of SYN-004 to degrade IV ceftriaxone in the presence of a proton pump inhibitor."