Aeromics Initiates Phase 1 Clinical Trial of CNS Edema Inhibitor AER-271 In Healthy Human Volunteers
- Category: Small Molecules
- Published on Tuesday, 10 July 2018 18:39
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BRANFORD, CT, USA I July 9, 2018 I Aeromics, Inc. ("Aeromics" or "the Company"), a privately-held, clinical-stage pharmaceutical company focused on controlling cerebral edema for people affected by disabling and life-threatening severe ischemic stroke, announced today the initiation of a Phase 1 clinical trial in healthy volunteers of its first-in-class drug candidate, AER-271.
Aeromics is conducting a double-blind, randomized, placebo-controlled Phase 1 clinical trial with their intravenously (IV) administered prodrug AER-271 which is designed to deliver therapeutically effective concentrations of the active component AER-270. The clinical study will include 78 healthy human volunteers at the Covance, Inc. cGMP Phase 1 facility in Dallas, Texas. The first cohort was dosed on June 26, 2018. The Company expects to complete the Phase 1 trial, which is designed to determine pharmacokinetics, safety and tolerability of AER-271 in single ascending and multiple ascending doses, in May 2019.
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 (LHI).
Dr. Paul R. McGuirk, Ph.D., Head of Clinical Development, stated, "We are very excited to have reached this milestone in the development path for AER-271, particularly because the effects of large hemispheric infarction are devastating - leading to long-term care, major costs to the healthcare system and even death." Dr. McGuirk added, "AER-271 has the potential to offer patients and physicians a new life-saving treatment option that will lead to improved outcomes in this poorly served area."
Dr. Marc F. Pelletier, Ph.D., President & CEO, added, "The initiation of our Phase 1 study represents the first Aquaporin inhibitor to enter first-in-human trials. Our team is excited about AER-271 and its 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."
Every 50 seconds someone in the United States suffers from a stroke. Roughly 800,000 strokes are seen in the U.S. each year, of which approximately 692,000 are acute ischemic strokes.
An estimated 140,000 patients with large hemispheric infarction suffer life-threatening and severely disabling cerebral edema and would benefit from an anti-edema medication.
AER-271 is a patented IV 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. AER-271 is an investigational drug and is not approved by the United States Food and Drug Administration.
Aeromics, Inc. is a privately-held, clinical-stage pharmaceutical company 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. Aeromics was founded in 2006 by two Yale University scientists.