U.S. FDA Grants Fast Track Designation to ReAlta Life Sciences’ Lead Compound RLS-0071 for the Treatment of Hypoxic-Ischemic Encephalopathy in Neonates
NORFOLK, Va.–(BUSINESS WIRE)–ReAlta Life Sciences (“ReAlta”), Inc., a clinical-stage rare disease company dedicated to harnessing the power of the immune system to fight life-threatening diseases, announced today Today the United States Food and Drug Administration (FDA) has granted Fast Track Designation to RLS-0071 for the treatment of Hypoxic Ischemic Encephalopathy (HIE). RLS-0071 is the company’s leading dual action complement inhibitor and innate anti-inflammatory peptide.
“Based on our compelling preclinical data and the strong safety profile established in our Phase 1 study in healthy volunteers, we believe we have the opportunity to dramatically change the way we treat HIE and other rare diseases,” said Ulrich Thienel, CEO of ReAlta. “The Fast Track designation speaks to the unmet need for HIE and will support closer collaboration with the FDA on our clinical development plan and work towards earlier drug approval and patient access.
Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and address an unmet medical need. The benefits of this designation include more frequent meetings with the FDA to discuss the drug’s development plan and ensure the collection of appropriate data needed for drug approval, as well as more frequent written communication to discuss aspects such as as the design of proposed clinical trials and the use of biomarkers. A drug that receives Fast Track designation may also be eligible for expedited approval and priority review.
HIE, also known as birth asphyxia, is a rare condition that affects newborns with sudden and unexpected loss of oxygenation due to placental rupture, umbilical cord problems, or heart disease. other factors. The initial loss of oxygen and the subsequent dysregulated inflammatory process cause damage to the brain and other organs. This acute illness often results in death or moderate to severe cognitive and physical disability, with lifelong impacts on the newborn and their family.
RLS-0071 is a 15 amino acid peptide that inhibits both humoral inflammation by blocking classical complement activation and cellular inflammation by blocking neutrophil myeloperoxidase (MPO) effectors and neutrophil extracellular traps (NET).
About ReAlta Life Sciences
ReAlta Life Sciences, Inc. is a clinical-stage rare disease biotechnology company dedicated to harnessing the power of the immune system to fight life-threatening diseases. The Company’s EPICC peptides are based on research on the human astrovirus HAstV-1, which causes a non-inflammatory, self-limiting gastroenteritis unique among viruses by inhibiting components of the innate immune system. ReAlta’s therapeutic peptides take advantage of these virus-derived mechanisms to rebalance complement and inflammatory processes in the body. The Company’s pipeline is led by RLS-0071, which has received IND clearance and orphan drug designation from the U.S. Food and Drug Administration and European Medicines Agency for the treatment of encephalopathy hypoxic-ischemic (HIE) in neonates. The company was launched in 2018 and is located in Norfolk, Virginia. For more information, please visit www.realtalifesciences.com.