Synthetic Biologics Inc (NYSE MKT:SYN), a clinical-stage company focused on developing therapeutics to protect the microbiome while targeting pathogen-specific diseases, dosed the first participant in a second Phase 2a clinical trial of SYN-004. This trial will evaluate the gastrointestinal (GI) antibiotic-degrading effects and the safety of SYN-004, in the presence of the proton pump inhibitor (PPI), esomeprazole. SYN-004 is the Company’s candidate therapy designed to degrade certain intravenous (IV) beta-lactam antibiotics within the GI tract and maintain the natural balance of the gut microbiome for the prevention of C. difficile infection, antibiotic-associated diarrhea (AAD) and secondary antibiotic-resistant infections.
C. difficile is the leading type of hospital acquired infection and is frequently associated with IV antibiotic treatment. Beta-lactam antibiotics are a mainstay in hospital infection management, and include commonly used penicillin and cephalosporin antibiotics, such as ceftriaxone. However, antibiotics have the potential to cause unintended harmful effects within the GI tract, including disruption of the natural balance of the gut microbiome, leading to 1.1 million C. difficile infections[i] and 30,000 C. difficile-related deaths[ii] in the United States each year.
PPIs are often used prophylactically in hospitalized patients. Therefore, with guidance from the U.S. Food and Drug Administration (FDA), Synthetic Biologics is conducting this study to demonstrate the ability of SYN-004 to degrade an intravenous (IV) antibiotic in the presence of a PPI.
“As participants complete the first Phase 2a clinical trial of SYN-004, they have the option to continue the evaluation of SYN-004 by moving into this second Phase 2a clinical trial,” stated Joseph Sliman, M.D., M.P.H., Senior Vice President, Clinical & Regulatory Affairs of Synthetic Biologics. “Collecting data in this second Phase 2a trial allows us to build a pharmacokinetics (PK) model, a valuable tool when other antibiotics are evaluated in the future. We want to clearly demonstrate the ability of SYN-004 to degrade antibiotics in the gut, to protect the microbiome from the damaging effects of antibiotics and dramatically reduce C. difficile infections through prevention vs. treatment. We remain on track to complete and report preliminary data from the first Phase 2a clinical trial within the month, and to initiate the Phase 2b clinical trial in the third quarter of this year.”
This second Phase 2a multi-center, open-label, 2-period, fixed-sequence study is expected to evaluate the ability of SYN-004 to degrade residual IV ceftriaxone in the GI tract in the presence of a PPI in up to 20 healthy participants with functioning ileostomies. The study consists of two treatment periods for all participants: 1) the administration of SYN-004 and IV ceftriaxone, and 2) the administration of SYN-004 and IV ceftriaxone in the presence of esomeprazole, an approved, over-the-counter PPI. Chyme samples will be collected from the participants to measure the ability of SYN-004 to degrade the residual antibiotic. Participants are expected to be enrolled at up to four trial sites located in the United States and Canada. (Original Source)
Shares of Synthetic Biologics closed yesterday at $2.62 . SYN has a 1-year high of $3.18 and a 1-year low of $1.32. The stock’s 50-day moving average is $2.16 and its 200-day moving average is $2.00.
On the ratings front, Synthetic Biologics has been the subject of a number of recent research reports. In a report issued on June 5, William Blair analyst Y Katherine Xu reiterated a Buy rating on SYN, with a price target of $12, which represents a potential upside of 358.0% from where the stock is currently trading. Separately, on June 4, H.C. Wainwright’s Andrew Fein maintained a Buy rating on the stock and has a price target of $4.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Y Katherine Xu and Andrew Fein have a total average return of 17.8% and 26.9% respectively. Xu has a success rate of 59.5% and is ranked #482 out of 3623 analysts, while Fein has a success rate of 69.7% and is ranked #86.
Synthetic Biologics Inc is a biotechnology company focused on the development of novel anti-infective biologic and drug candidates targeting specific pathogens that cause serious infections and other diseases.