FDA Grants Fast Track Designation to ReAlta Life Sciences RLS-0071 for the Treatment of HIE in Neonates

The U.S. Food and Drug Administration granted ReAlta Life Sciences Fast Track designation to RLS-0071 for the treatment of hypoxic ischemic encephalopathy.

Photo: Ulrich Thienel, CEO of ReAlta

Hypoxic ischemic encephalopathy (HIE), also known as birth asphyxia, is a rare disease that affects newborns suffering an abrupt, unexpected loss of oxygenation due to placental rupture, umbilical cord problems, or other factors. The initial loss of oxygen and the dysregulated inflammatory process that follows causes damage to the brain and other organs. This acute disease often results in death or moderate-to-severe cognitive and physical disability, with life-long impacts on both the newborn and the newborn’s family.

RLS-0071 is a 15 amino acid peptide that both inhibits humoral inflammation by blocking classical pathway complement activation and cellular inflammation by blocking the neutrophil effectors myeloperoxidase (MPO) and neutrophil extracellular traps (NETs).

Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Benefits of this designation include more frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval, as well as more frequent written communication to discuss aspects such as the design of the proposed clinical trials and use of biomarkers. A drug that receives Fast Track designation may also be eligible for Accelerated Approval and Priority Review.

“We believe we have an opportunity to radically change the way we treat HIE and other rare diseases,” said Ulrich Thienel, CEO of ReAlta. “The designation of Fast Track is a testament to the unmet need in HIE and will support a closer collaboration with FDA on our clinical development plan and work to earlier drug approval and access by patients.”

Author: Rare Daily Staff