SYN-005 is being developed through Synthetic Biologics’ exclusive channel collaboration with Intrexon (XON) and academic researchers at the University of Texas at Austin to target and neutralize the pertussis toxin to reduce morbidity and mortality in infected infants.
Pertussis is caused by the bacteria Bordetella pertussis (B. pertussis) with symptoms that may include chronic coughing and subsequent breathing difficulties.
Across the world, there are about 50 million cases of whooping cough each year, leading to an estimated 300,000 deaths, primarily among young, unvaccinated infants, according to the World Health Organization (WHO).
The FDA orphan drug status provides a variety of incentives, including seven years of market exclusivity, if SYN-005 gets approval for the treatment of Pertussis.
Synthetic Biologics chief executive officer Jeffrey Riley said achieving this milestone is an important step in building the foundation for our Pertussis clinical program.
"The next anticipated milestone for SYN-005 is to initiate cGMP manufacturing in the second half of this year, followed by the filing of an IND in mid-2015 to support the initiation of a Phase I clinical trial," Riley said.
"We expect this to become an important new treatment option for patients suffering from Pertussis."
The company intends to file investigational new drug (IND) application to support clinical trials in mid-2015.