The trial is a double-blind, randomized, placebo-controlled phase 1 clinical trial with intravenously administered prodrug AER-271 which is designed to deliver therapeutically effective concentrations of the active component AER-270.
The data obtained in this study will be used to inform the design of a planned, potentially pivotal, multi-center phase 2 efficacy trial in severe ischemic stroke patients with large hemispheric infarction.
AER-271 is a patented intravenous prodrug that delivers AER-270, a potent inhibitor of aquaporin-4 (AQP4) water channels, to the neurovascular unit. These channels are the primary route of water movement into the central nervous system under conditions of ischemia.
The osmotic imbalance and subsequent influx of water via AQP4 occurs as a result of a lack of oxygen and leads to edema, midline shift, increased intracranial pressure, and brain herniation resulting in permanent disability or mortality.
Privately-held Aeromics, founded in 2006 by two Yale University scientists, is developing a first-in-class anti-edema therapy to treat patients affected by acute central nervous system edema as a consequence of large hemispheric infarction.
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