Synthetic Biologics, Inc., said on Wednesday that its pertussis therapy medication, SYN-005, has produced positive research findings in preclinical tests in non-human primate studies.
The new treatment is a monoclonal antibody combination therapy developed through an Exclusive Channel Collaboration with Intrexon Corporation and the University of Texas at Austin.
During a study, the treatment produced encouraging decreases of white blood cell counts within two days and produced almost normal levels within one week.
Synthetic Biologics said it will file an Investigational New Drug application to initiate a Phase 1 clinical trial in 2015. It is also seeking an Orphan Drug designation for the drug.
Pertussis, commonly known as whooping cough, is caused by the Bordetella pertussis bacteria and is highly contagious. Symptoms include chronic coughing and difficulty breathing. The World Health Organization reports that pertussis causes approximately 300,000 deaths each year.
"There is a critical need to address the re-emergence of pertussis as a rising public health concern," Synthetic Biologics CEO Jeffery Riley said. "The growing body of evidence for SYN-005 provides strong support for its clinical development as potentially a new treatment approach and the only one designed to neutralize the pertussis toxin itself. We believe this novel intervention has the potential to mitigate the course of the illness, which, in human infants, could potentially be life-saving."