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news.Trillium Therapeutics has revealed that its product, TTI-1612, has been designated an orphan drug by the European Medicines Agency, and the FDA, for a condition associated with premature babies.
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Necrotizing enterocolitis (NEC) is a medical condition primarily seen in premature infants, where portions of the bowel undergo tissue death.
“Orphan drug status provides TTI-1612 with up to seven and ten years of market exclusivity in the US and Europe respectively, which significantly enhances its commercial potential”, said CEO Dr Niclas Stiernholm. “This may also generate opportunities for additional funding, as well as expert advice and assistance with regulatory issues and trial design.”
TTI-1612 has shown remarkable efficacy in preclinical animal models of NEC and may have additional utility in the treatment of other intestinal disorders, such as short bowel syndrome, inflammatory bowel disease and chemotherapy-induced mucositis.
According to Trillium, NEC is now the most common surgical emergency procedure in the neonatal intensive care unit. Approximately 30% of afflicted neonates die of NEC-related complications.