Virginia-based ReAlta Life Sciences Inc., closed an oversubscribed USD 40 million financing round to advance pegtarazimod, its lead candidate for hypoxic ischemic encephalopathy (HIE), a neonatal brain injury condition with no approved drug therapies. The round brings total capital raised by the company to more than USD 150 million since its formation in 2018.
The announcement did not identify the investors participating in the round. Proceeds will be directed toward completing the Phase II STAR trial (NCT05778188) in HIE, generating top-line data, and convening an End-of-Phase II meeting with the US FDA.
Pegtarazimod (RLS-0071) is a 15-amino-acid peptide that simultaneously targets two arms of the innate immune system implicated in acute inflammatory tissue damage. The molecule inhibits complement activation at C1, blocking the classical complement pathway at its initiation point, while also suppressing myeloperoxidase activity and neutrophil extracellular trap formation — mechanisms that drive oxidative tissue injury and amplify the inflammatory cascade. The scientific basis for the molecule traces to a mechanistic observation derived from human astrovirus HAstV-1, a pathogen associated with non-inflammatory gastroenteritis, which provided a peptide scaffold for innate immune modulation.
Pegtarazimod holds US FDA Orphan Drug and Fast Track Designations for HIE, as well as an EMA Orphan Drug Designation for the same indication. The STAR trial is a two-stage, randomized, double-blind, placebo-controlled study currently enrolling newborns with moderate or severe HIE across 13 neonatal intensive care units in the US. HIE, caused by oxygen and blood flow deprivation to the brain around the time of birth, remains a leading cause of neonatal mortality and long-term neurological disability including cerebral palsy and epilepsy. Therapeutic hypothermia is the current standard of care; no pharmacological agent has received regulatory approval for the condition. The company is also conducting a Phase II study of pegtarazimod in steroid-refractory acute graft-versus-host disease (NCT06343792), though this program was not referenced in the financing announcement.
Spot something wrong? Report an issue with this article