ReAlta Life Sciences has secured $40m to back the continuation of a Phase II study of its lead candidate, pegtarazimod, in hypoxic ischemic encephalopathy (HIE).
In conversation with Clinical Trials Arena, Kia Motesharei, President and COO at ReAlta, noted that the company will use the funds to accelerate recruitment in the STAR trial (NCT05778188) – which is currently on track to reach its recruitment target of 70 infants.
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The biopharma will seek out additional sites for its trial, adding to the 13 US locations the company is already working with.
ReAlta’s mid-stage study is exploring pegtarazimod’s potential to treat neonatal HIE alongside cooling therapy, which remains the standard of care (SoC) treatment for infants diagnosed with HIE. The Virginia-based biopharma expects to complete recruitment for the study in late Q3 2026, with topline results expected soon after this milestone.
In the first phase of the study, ReAlta will assess the safety and tolerability of intravenous pegtarazimod, as well as its preliminary efficacy and pharmacokinetics (PK) in newborn infants with moderate-to-severe HEI over a 14-day period. Patients receive three ascending doses of the drug or placebo daily during the first 72 hours. The primary endpoints focus on the prevalence and severity of treatment-emergent adverse events (TEAEs), as well as the degree of acute brain injury between treatment and placebo measured by magnetic resonance imaging (MRI).
According to Motesharei, the $40m raised in this round sets ReAlta up with a stable cash runway “well into 2027”, to support the STAR milestones, interactions with regulators and potential early preparation for Phase III. Depending on the mid-stage results, Motesharei added that ReAlta will look to raise further funds to initiate a Phase III study on pegtarazimod in HIE.
Breaking open the HIE therapeutic market
Currently, researchers estimate that 1.2 million babies globally develop HIE each year, with up to a 60% fatality rate. Despite the strong burden of HIE on neonates and parents alike, a drug has yet to secure approval in this indication.
ReAlta hopes to change this paradigm with pegtarazimod, an astrovirus-derived peptide that the company says could improve HIE outcomes by blocking upstream cellular inflammation cascades. The drug acts by inhibiting complement activation via C1, while inhibiting the myeloperoxidase (MPO) enzyme and diminishing the formation of neutrophil extracellular traps (NETs).
“Pegtarazimod activates two different inflammatory pathways, while secondarily blocking the MPOs, which allow us to reduce the impact of oxidative stress in infants with HIE,” Motesharei commented.
This multi-pronged approach to treatment of the heterogeneous disease differs from previous drugs developed in this indication, Motesharei says, which could see pegtarazimod succeed where its singular target-focused predecessors have failed.
In a bid to get pegtarazimod to patients as quickly as possible, ReAlta is pursuing an accelerated approval based on surrogate endpoints, which it will choose in tandem with regulators.
If the drug were to get the regulatory greenlight, it could become both a first-in-class and first-in-disease pharmaceutical – potentially offering a new SoC alongside cooling therapy within the indication.
ReAlta was alsop previously evaluating pegtarazimod’s potential in steroid-refractory acute graft-versus-host disease (aGvHD).
