Neurorx, Relief, and Quantum Leap Announce the Inclusion of Zyesami (Rlf-100: Aviptadil) in the I-Spy Covid-19 Trial
January 11, 2021 at 01:00 am EST
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NeuroRx, Inc. and RELIEF THERAPEUTICS Holding AG and the Quantum Leap Healthcare Collaborative of San Francisco announce that NeuroRx and QLHC have signed a Clinical Trial Participation Agreement for the inclusion of ZYESAMI (RLF-100TM: aviptadil) in the I-SPY COVID-19 Clinical Trial. Quantum Leap is the sponsor of the I-SPY COVID-19 Trial, a platform trial that is assessing multiple drugs for the treatment of patients with Critical COVID-19 who are hospitalized or in intensive care units. ZYESAMI will be included as one of the first drugs targeting Respiratory Failure in critically ill COVID-19 patients. The inclusion of ZYESAMI in the I-SPY COVID-19 Trial follows a request from the U.S. Department of Health and Human Services and the Department of Defense for investigational drugs capable of targeting the most acutely ill patients with COVID-19. ZYESAMI has been granted Fast Track designation by the U.S. Food & Drug Administration (FDA) for the treatment of Critical COVID-19 in patients with Respiratory Failure. I-SPY is a platform clinical trial that uses a similar protocol as a traditional clinical trial, but that compares multiple investigational agents combined with a "backbone" of the standard of care. The trial is designed to rapidly identify those agents that have a large impact on reducing disease severity, including reduced mortality, reducing or avoiding time on ventilation and other longer-term comorbidities. Patients receive one of several products being studied and the results then are compared to the current standard of care.
NRX Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company. The Company is developing therapeutics based on its N-methyl-D-aspartate (NMDA) platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain, and post-traumatic stress disorder (PTSD). The Company has two lead compounds, NRX-100, a proprietary presentation of ketamine and NRX-101, a fixed-dose combination of D-cycloserine (DCS) and lurasidone. The Company is developing NRX-101, a Food and Drug Administration (FDA)-designated investigational therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRX-101 is a combined NMDA/5-HT2A-targeted medicine designed to address both depression and suicidal ideation, consisting of an oral, fixed dose combination of DCS and lurasidone. Its NRX-100 is racemic ketamine, which is a generic anesthetic. The Company is also engaged in the development of its new product, NRX-102.