ROCKVILLE, MD, USA I September 20, 2016 I Synthetic Biologics, Inc. (NYSE MKT: SYN), a clinical stage company focused on developing therapeutics to protect the gut microbiome while targeting pathogen-specific diseases, announced today that following the completion of a previously planned interim analysis by an independent Interim Analysis Committee (IAC), enrollment has been completed in its Phase 2b randomized, placebo-controlled, proof-of-concept clinical trial for SYN-004 (ribaxamase).
Following a closed session with the IAC in which the Company remained blinded to the study data, a recommendation was given to continue the study per protocol without modification and no safety issues were identified. Successful enrollment of 413 patients has occurred exceeding the desired sample size of 372 patients outlined per the study protocol. All ongoing patients are expected to continue through the follow-up period in order to complete the study. The Company anticipates announcing top-line results during the first quarter of 2017.
“The completion of enrollment in our Phase 2b proof-of-concept study for ribaxamase represents a critical milestone for the company and one that exhibits our continued focus of moving our innovative approach to preventing CDI, AAD and antibiotic resistance into late-stage clinical development,” said Jeffrey Riley, President and Chief Executive Officer. “We would like to thank the patients and clinical sites that are participating in this study as well as our colleagues for their commitment and dedication to this important and potentially groundbreaking clinical trial. We look forward to announcing top-line results during the first quarter of 2017.”
About SYN-004 (ribaxamase) and the Phase 2b Study
SYN-004 (ribaxamase) is a first-in-class oral enzyme designed to degrade certain IV beta-lactam antibiotics within the GI tract and maintain the natural balance of the gut microbiome for the prevention of CDI, AAD and the emergence of antibiotic-resistant organisms. The Phase 2b proof-of-concept clinical trial is intended to evaluate the effectiveness of ribaxamase to prevent the onset of C. difficile infection (CDI), C. difficile associated diarrhea (CDAD), antibiotic-associated diarrhea (AAD) and the emergence of antibiotic-resistant organisms in patients hospitalized with a lower respiratory infection and receiving intravenous (IV) ceftriaxone. To access the ribaxamase mechanism of action video on Synthetic Biologics’ website, please click here.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a clinical stage company developing therapeutics to protect the gut microbiome while targeting pathogen-specific diseases. The Company’s lead candidates poised for Phase 3 development are: (1) SYN-010 which is intended to reduce the impact of methane producing organisms in the gut microbiome to treat an underlying cause of irritable bowel syndrome with constipation (IBS-C), and (2) SYN-004 (ribaxamase) which is designed to protect the gut microbiome from the effects of certain commonly used intravenous (IV) beta-lactam antibiotics for the prevention of C. difficile infection, antibiotic-associated diarrhea (AAD) and the emergence of antibiotic-resistant organisms. The Company is also developing preclinical stage monoclonal antibody therapies for the prevention and treatment of pertussis and novel discovery stage biotherapeutics for the treatment of phenylketonuria (PKU). For more information, please visit Synthetic Biologics’ website at www.syntheticbiologics.com.
SOURCE: Synthetic Biologics
Post Views: 231
ROCKVILLE, MD, USA I September 20, 2016 I Synthetic Biologics, Inc. (NYSE MKT: SYN), a clinical stage company focused on developing therapeutics to protect the gut microbiome while targeting pathogen-specific diseases, announced today that following the completion of a previously planned interim analysis by an independent Interim Analysis Committee (IAC), enrollment has been completed in its Phase 2b randomized, placebo-controlled, proof-of-concept clinical trial for SYN-004 (ribaxamase).
Following a closed session with the IAC in which the Company remained blinded to the study data, a recommendation was given to continue the study per protocol without modification and no safety issues were identified. Successful enrollment of 413 patients has occurred exceeding the desired sample size of 372 patients outlined per the study protocol. All ongoing patients are expected to continue through the follow-up period in order to complete the study. The Company anticipates announcing top-line results during the first quarter of 2017.
“The completion of enrollment in our Phase 2b proof-of-concept study for ribaxamase represents a critical milestone for the company and one that exhibits our continued focus of moving our innovative approach to preventing CDI, AAD and antibiotic resistance into late-stage clinical development,” said Jeffrey Riley, President and Chief Executive Officer. “We would like to thank the patients and clinical sites that are participating in this study as well as our colleagues for their commitment and dedication to this important and potentially groundbreaking clinical trial. We look forward to announcing top-line results during the first quarter of 2017.”
About SYN-004 (ribaxamase) and the Phase 2b Study
SYN-004 (ribaxamase) is a first-in-class oral enzyme designed to degrade certain IV beta-lactam antibiotics within the GI tract and maintain the natural balance of the gut microbiome for the prevention of CDI, AAD and the emergence of antibiotic-resistant organisms. The Phase 2b proof-of-concept clinical trial is intended to evaluate the effectiveness of ribaxamase to prevent the onset of C. difficile infection (CDI), C. difficile associated diarrhea (CDAD), antibiotic-associated diarrhea (AAD) and the emergence of antibiotic-resistant organisms in patients hospitalized with a lower respiratory infection and receiving intravenous (IV) ceftriaxone. To access the ribaxamase mechanism of action video on Synthetic Biologics’ website, please click here.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a clinical stage company developing therapeutics to protect the gut microbiome while targeting pathogen-specific diseases. The Company’s lead candidates poised for Phase 3 development are: (1) SYN-010 which is intended to reduce the impact of methane producing organisms in the gut microbiome to treat an underlying cause of irritable bowel syndrome with constipation (IBS-C), and (2) SYN-004 (ribaxamase) which is designed to protect the gut microbiome from the effects of certain commonly used intravenous (IV) beta-lactam antibiotics for the prevention of C. difficile infection, antibiotic-associated diarrhea (AAD) and the emergence of antibiotic-resistant organisms. The Company is also developing preclinical stage monoclonal antibody therapies for the prevention and treatment of pertussis and novel discovery stage biotherapeutics for the treatment of phenylketonuria (PKU). For more information, please visit Synthetic Biologics’ website at www.syntheticbiologics.com.
SOURCE: Synthetic Biologics
Post Views: 231
