Prometic Life Sciences Inc announced today that an orphan drug designation status has been granted to its Inter-Alpha-Inhibitor-Proteins (“IaIp”) for the treatment of necrotizing enterocolitis (“NEC”) by the US Food and Drug Administration.

IaIp are endogenous proteins that control excessive inflammatory responses to toxins, infectious organisms, and tissue and organ damage. An inverse correlation between IaIp levels in plasma and disease severity / mortality has been demonstrated in humans with sepsis.  In a gold-standard animal model proven to emulate NEC in humans, the supplementation of IaIp significantly increased the survival rate.  

“We know that IaIp are rapidly consumed and cleared from circulation during severe sepsis cases, as evidenced by the significantly lower plasma levels of IaIp in newborns suffering from NEC. There is also strong scientific evidence indicating that IaIp play a key role in modulating systemic inflammation”, said Dr. John Moran, Prometic’s chief medical officer. “We believe that systemic IaIp administration to replenish these decreased levels could therefore reduce the severity of inflammation and resulting tissue injury experienced by NEC patients”.  

NEC is the most common acquired gastrointestinal disease diagnosed in premature neonates and is one of the leading causes of death in neonatal intensive care units. The economic cost of NEC is high, accounting for approximately 19% of neonatal expenditures and an estimated $5 billion per year for hospitalizations in the United States alone.