Aeromics has begun a Phase l clinical trial of AER-271 to treat severe ischemic stroke.
The double-blind, randomised, placebo-controlled trial intends to investigate the pharmacokinetics, safety and tolerability of AER-271 in single-ascending and multiple-ascending doses of AER-271.
As part of the trial, AER-271 will be administered intravenously (IV) to a total of 78 healthy subjects at Covance’s cGMP facility in Dallas, Texas.
Aeromics had already dosed the first cohort last month and expects to complete the trial by May next year.
Results from the trial will be used to outline the design of a proposed, potentially pivotal, multi-centre Phase ll efficacy study of AER-271 in severe ischemic stroke patients with Large Hemispheric Infarction (LHI).
Aeromics president and CEO Dr Marc Pelletier said: “The initiation of our Phase l study represents the first Aquaporin inhibitor to enter first-in-human trials.
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“Our team is excited about AER-271 and it’s application to edema control in severe stroke. AER-271 could offer a critical step forward in treatment options for physicians.
“Due to the late onset of edema, this new therapy would significantly extend the time-to-treatment window over the standard of care tPA. Many more patients will benefit than is currently possible.”
AER-271 is an investigational IV prodrug that is designed to provide AER-270, a potent inhibitor of Aquaporin-4 (AQP4) water channels, to the neurovascular unit.
The AQP4 channels are the main route used to move water into the central nervous system under conditions of ischemia.