BRIEF—Boost for Plakous' placental extract for preterm infants

Privately-held US firm Plakous Therapeutics has been granted orphan drug and rare pediatric disease designations by the US Food and Drug Administration for its human placental extract, Protego-PD, for the prevention of necrotizing enterocolitis (NEC) in early preterm infants.

NEC is caused by inflammation and lack of development of the intestine and is observed in very low birth weight babies, those babies born weighing less than three pounds.

Robert Boyce, chief executive of Plakous, said: “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.

“The team is excited by this news and its important role in our commercialization strategy. In the meantime, we are focused on expanding our successful pre-clinical data and achieving the regulatory milestones to develop the first FDA-approved treatment for the prevention of NEC.”