Synthetic Biologics Pertussis Drug Granted Orphan Drug Designation by FDA

Synthetic Biologics Pertussis Drug Granted Orphan Drug Designation by FDA

PertussisPertussis, or “whooping cough” is a very contagious respiratory infection that commonly affects infants and young children. While it can also be transmitted to older individuals, it poses the biggest threat in non-vaccinated babies less than a year old. Worldwide, this serious bout of cough claims nearly 200,000 lives every year.

Synthetic Biologics, Inc. announced last week that one of their leading product candidates for pertussis, SYN-005, has received an Orphan Drug Designation from the US Food and Drug Administration — an appointment given exclusively to pharmaceutical companies developing a treatment for a rare disease, which entitles them to a number of benefits upon receiving FDA approval such as having the privilege to market the product without competition for 7 years, along with clinical trial tax incentives.

While the company still has a long way to go with SYN-005’s development and testing, as this designation does not particularly label a product as safe, Synthetic Biologics’ CEO, Jeffrey Riley takes it as an important milestone for the product’s clinical program as it should bolster future applications needed to advance it.

SYN-005 is a monoclonal antibody formulation the company developed in partnership with Intrexon Corporation, and scientists from the University of Texas, Austin. It is formulated to seek out and neutralize the toxins secreted by the Bordetella pertussis bacteria.

Earlier this year, a study from Baylor College of Medicine recommended that expectant mothers in their third trimester get vaccinated against pertussis as it could help protect the newborn from the disease through transplacental antibodies, for up to a few months from birth.

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