First Patient Enrolled In Phase 3 Trial Of Inhaled Xenon Gas Therapy Announced by Mallinckrodt And NPXe

Mallinckrodt plc, a leading global specialty pharmaceutical company, and NPXe Limited (NPXe) today confirmed enrollment of the first patient in the pivotal Phase 3 trial of Xenon Gas for Post Cardiac Arrest Syndrome (PCAS). Xenon gas for inhalation is an investigational drug, the safety and effectiveness of which have not yet been established. Mallinckrodt will pay NPXe $5 million as recognition of this milestone achievement per the terms of the License and Commercialization Agreement between the parties.

The clinical study is targeting approximately 1,400 patients suffering an out-of-hospital cardiac arrest who have been successfully resuscitated, and will compare 24 hours of xenon gas treatment, in combination with targeted temperature management (TTM), with the current standard of care, which is TTM alone. The study is expected to include about 70 study centers across the U.S. and Europe, and will look for an improvement in functional outcomes and reduced mortality rates. The companies expect an interim analysis of the study to occur in the fourth quarter of 2019 and for the study to complete in 2020.

PCAS is a range of complications, principally to the brain and the heart which follow the sudden loss of blood flow (ischemia) after a cardiac arrest and the subsequent reflow of blood (reperfusion) following successful resuscitation. There is no approved pharmacotherapy for neuroprotection for PCAS. There are approximately 140,000 potential cardiac arrest patients in the U.S. and 145,000 in Europe each year who may be eligible for xenon gas treatment, if approved.

The U.S. Food and Drug Administration (FDA) approved a Special Protocol Assessment[1] for the trial and the drug has been granted its Fast Track designation[2]. The companies expect the regulatory submission to be a drug and delivery device combination.

Matt Napoletano, COO of NPXe, commented, “Our goal is to have approximately 70 sites eligible to enroll patients in the XePOHCAS trial in North America and Europe. Many sites have demonstrated substantial interest in participating in the trial due to the unmet medical need.”

“The enrollment of the first patient in this study is an important step in addressing this critical unmet medical need,” said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt. “If the Phase 3 trial is successful, we believe xenon gas for inhalation, if approved, has the potential to change treatment paradigms, adding a therapeutic option in a population of resuscitated cardiac arrest patients.”

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