The Food and Drug Administration (FDA) has granted Orphan Drug and Rare Pediatric Disease designations to Protego-PD™ (Plakous Therapeutics), a human placental extract, for the prevention of necrotizing enterocolitis in early preterm infants.

Necrotizing enterocolitis (NEC) is a rare disease that causes inflammation of the intestines and primarily affects very low birth weight babies weighing less than 3 pounds. Protego-PD is an oral acellular biotherapeutic derived from post-delivery placentas.

The designations are supported by preclinical data that showed Protego-PD prevented necrotizing enterocolitis in premature piglets. According to the Company, the treatment has the potential to reduce costs associated with NEC by reducing the time in the neonatal intensive care unit as well the need for surgery. 

“With no currently approved treatment for NEC, receiving these designations is a significant step forward to stop this devastating disease from affecting fragile, premature babies,” said Robert Boyce, CEO of Plakous Therapeutics.

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The Company is also investigating the use of Protego-PD for the treatment of osteoarthritis.

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