NRx Pharmaceuticals and Quantum Leap Announce Treatment of Severely Ill COVID-19 Patients with ZYESAMIÔ (Aviptadil) in the I-SPY COVID Trial
NRx Pharmaceuticals and Quantum Leap Healthcare Collaborative have commenced treatment of severely ill COVID-19 patients with inhaled ZYESAMI (Aviptadil) in the I-SPY COVID Trial. This Phase 2 trial focuses on assessing multiple agents simultaneously to reduce mortality and mechanical ventilation needs in these patients. Initial results from intravenous ZYESAMI indicate improved 60-day survival rates. The trial also aims to evaluate the potential efficacy of nebulized ZYESAMI, with the support of BARDA and the Department of Defense.
- Initiation of treatment with inhaled ZYESAMI in the I-SPY COVID Trial could lead to improved clinical outcomes for severely ill COVID-19 patients.
- ZYESAMI has shown statistically significant results in increasing survival rates in earlier clinical trials, which may enhance its market position.
- The outcome of the trial is uncertain, and there is no guarantee that inhaled ZYESAMI will demonstrate the same efficacy as intravenous administration.
- Dependence on external funding from BARDA and DoD raises concerns regarding financial sustainability if funding is reduced or withdrawn.
SAN FRANCISCO and RADNOR, Pa., July 12, 2021 /PRNewswire/ -- NRx Pharmaceuticals, Inc. ("NRx") (Nasdaq: NRXP) and Quantum Leap Healthcare Collaborative™ (Quantum Leap) have begun treating patients with inhaled ZYESAMIÔ (Aviptadil), in the I-SPY COVID Trial (NCT04488081), a phase 2 adaptive platform trial aimed at improving treatment for severely and critically ill COVID-19 patients.
The I-SPY COVID Trial utilizes Quantum Leap's adaptive platform trial design methodology, which focuses on the efficient assessment of multiple investigational agents simultaneously.
The objective of the trial is to screen a variety of promising agents for the treatment of severely and critically ill COVID-19 patients. Specifically, the goal is to identify agents that have a high impact on reducing mortality, as well as the need for and duration of mechanical ventilation.
ZYESAMI™ has demonstrated a statistically-significant increase in the likelihood of patients being alive and free of respiratory failure at 60 days when administered by intravenous infusion in a phase 2b/3 clinical trial in post-hoc analyses. In the I-SPY COVID Trial, inhaled ZYESAMI will be given to critically ill patients in order to determine whether inhaled administration has the potential to achieve similar results.
About ZYESAMI™ in COVID-19
ZYESAMI™ (Aviptadil Acetate) is a synthetic form of Vasoactive Intestinal Polypeptide (VIP) that was first discovered by the late Prof. Sami Said. ZYESAMI™ (Aviptadil) is named in his honor, and was selected for participation in the I-SPY COVID Trial study, in part, because of its anti-inflammatory properties. NRx Pharmaceuticals recently submitted an Emergency Use Authorization request to the U.S. Food and Drug Administration for ZYESAMI™ to treat Critical COIVD-19 patients with respiratory failure.
VIP binds specifically to the alveolar type II cell (ATII) in the air sac (alveolus) of the lung, where it has been shown have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation. Most importantly, VIP stimulates ATII cells to make the surfactant that must coat the lining of the lungs in order for them to exchange oxygen with the blood. Loss of surfactant causes respiratory failure and alveolar collapse, which are hallmarks of COVID-19.
The ATII cells are vulnerable because of their (ACE2) surface receptors, which serve as the route of entry for the virus. Coronavirus infection of the ATII cell shuts down surfactant production, triggers the formation of inflammatory cytokines, and causes cell death (cytopathy). ZYESAMI™ is currently the only proposed treatment for COVID-19 specifically targeting this mechanism of action.
The Aviptadil arm in the I-SPY COVID trial features nebulized administration in order to maximize the impact of this drug on the respiratory system and to minimize potential systemic side effects.
As noted by Dr. Laura Esserman, CO- PI of the I-SPY COVID Trial, "Based on demonstrating safety and improved time to recovery with intravenous administration in early stages of SARS-CoV-2, Aviptadil is being tested in the ACTIV trials for COVID. We are excited to partner with NRx to test whether nebulized delivery of Aviptadil, which is more easily and directly delivered to the damaged lungs, improves time to recovery and reduces mortality."
"This trial includes some of the sickest patients suffering from COVID-19, and through this study, we believe we will provide positive outcomes to help them recover more quickly and return home to their families," said Jonathan Javitt, MD, MPH, CEO and Chairman of the Board, of NRx. "Being selected for the I-SPY platform allows NRx the opportunity to work with some of the best physicians and scientists leading clinical trials, and we look forward to providing data to health regulatory authorities, pending the outcome of this trial."
This study is a collaboration between members of Quantum Leap, pharma partners such as NRx and the United States government. This work is supported in part, by the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, and the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, in collaboration with the Medical, Chemical, Biological, Radiological and Nuclear (CBRN) Defense Consortium (MCDC).
About the I-SPY COVID Trial
The I-SPY COVID Trial (Investigation of Serial Studies to Predict Your COVID Therapeutic Response with Biomarker Integration and Adaptive Learning) is an adaptive platform trial designed to increase trial efficiency by minimizing the number of participants and time required to evaluate experimental and/or repurposed drugs. The focus of the trial is to improve outcomes for severely-ill COVID-19 patients—those who require at least 6L of high-flow oxygen either by mask or nasal cannula, known as level 5 on the World Health Organization (WHO) COVID scale, an 8-point ordinal scale of clinical severity status. The primary endpoints include the time to achieve level 4 or less for at least 48 hours on the WHO COVID scale, a decrease in the duration of time on a ventilator, and a decrease in mortality.
The I-SPY COVID Trial is sponsored and managed by Quantum Leap Healthcare Collaborative. For more information, visit www.quantumleaphealth.org or www.ispytrials.org.
About Quantum Leap Healthcare Collaborative
Quantum Leap Healthcare Collaborative (Quantum Leap) is a 501c(3) charitable organization established in 2005 as a collaboration between medical researchers at University of California, San Francisco and Silicon Valley entrepreneurs. Our mission is to integrate high-impact research with clinical processes and systems technology, resulting in improved data management and information systems, greater access to clinical trial matching and sponsorship, and greater benefit to providers, patients, and researchers. Quantum Leap provides operational, financial, and regulatory oversight to all I-SPY Trials.
About NRx Pharmaceuticals
NRx (www.nrxpharma.com) draws upon more than 300 years of collective, scientific and drug-development experience to bring improved health to patients. In addition to its work on Aviptadil, the United States Food and Drug Administration has granted Breakthrough Therapy Designation and a Special Protocol Agreement to NRx to develop NRX-101, an investigational medicine to treat suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with readouts expected in 2022. NRx is led by executives who have held senior roles at Allergan, J&J, Lilly, Novartis, Pfizer, and the US FDA. NRx is publicly traded on the Nasdaq Global Select Exchange under the stock ticker NRXP.
Cautionary Note Regarding Forward-Looking Statements
This announcement of NRx Pharmaceuticals, Inc. includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements regarding our financial outlook, product development, business prospects, and market and industry trends and conditions, as well as the company's strategies, plans, objectives, and goals. These forward-looking statements are based on current beliefs, expectations, estimates, forecasts, and projections of, as well as assumptions made by, and information currently available to, the company's management.
The company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise. Accordingly, you should not place reliance on any forward-looking statement, and all forward-looking statements are herein qualified by reference to the cautionary statements set forth above.
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SOURCE Quantum Leap Healthcare Collaborative
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