ReAlta Life Sciences, Inc., announced that U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to PIC1-dPEG24 for the treatment of hypoxic-ischemic encephalopathy (HIE) in neonates. “There is an urgent need for new therapeutic options to treat hypoxic-ischemic encephalopathy, a devastating condition that profoundly impacts newborns and their families,†said Ulrich Thienel, M.D., Ph.D., ReAlta’s chief executive officer. “ReAlta is passionate about supporting this vulnerable population and bringing forward the first pharmacological therapy for the treatment of HIE. The orphan drug designation for our RLS-0071 compound is an important milestone in ReAlta’s strategic plan to advance our PIC1 platform to address life-threatening medical needs.†The FDA’s Office of Orphan Drug Products grants orphan status to drugs intended to treat rare disorders that affect fewer than 200,000 people in the U.S. The designation provides certain benefits to the drug developer, including seven years of market exclusivity upon FDA approval, prescription drug user fee waivers and tax credits for qualified clinical trials. ReAlta intends to submit an Investigational New Drug (IND) application to FDA for HIE later this year, begin first-in-man clinical studies in late 2020, and then begin HIE Phase 2 studies in neonates in 2021.
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