NRx Pharmaceuticals Announces Progress in Global Commercial Development of ZYESAMI ™ (aviptadil)
“As thousands of people around the world continue to die from COVID-19 every day, we continue our efforts to ensure that NRx has the necessary supplies and logistics to deliver ZYESAMI to patients where it was obtained. regulatory approval, ”said the professor Jonathan javitt, MD, MPH, CEO and President of NRx.
About ZYESAMI ™ / VIP in COVID-19
Aviptadil is a synthetic form of vasoactive intestinal polypeptide (VIP), first discovered by the late Prof. Sami Said in 1970, and ZYESAMI ™ is named in his honor. Although primarily concentrated in the lungs, it was first purified from the intestinal tract. VIP binds specifically to the type II alveolar cell (ATII) in the air sac (alveolus) of the lung, where it has been shown to have potent anti-inflammatory / anti-cytokine activity in animal models of distress respiratory, acute lung injury, and inflammation. Most importantly, VIP stimulates ATII cells to make the surfactant that must cover the lining of the lungs so that they exchange oxygen with the blood. The loss of surfactant causes respiratory failure and alveolar collapse, which are hallmarks of COVID-19.
Respiratory failure associated with COVID-19 is caused by selective infection of the ATII cell with the SARS-CoV-2 virus. ATII cells are vulnerable due to their surface receptors (ACE2), which serve as the entry route for the virus. Coronavirus infection of the ATII cell stops surfactant production, triggers the formation of inflammatory cytokines, and causes cell death (cytopathy). VIP has been shown to upregulate surfactant production, block coronavirus replication in the ATII cell, block cytokine synthesis, and prevent virus-induced cell death (cytopathy). Other than ZYESAMI ™, no currently proposed treatment for COVID-19 specifically targets this mechanism of action.
About NRx Pharmaceuticals
NRx Pharmaceuticals (NRx) draws on more than 300 years of collective, scientific and drug development experience to improve patient health. Its investigational product, ZYESAMI ™ (aviptadil) for patients with COVID-19, has received Fast Track designation from the United States Food and Drug Administration (FDA) and is currently in phase 3 funded trials. by the United States National Institutes of Health, the Biomedical Advanced Research and Development Authority, part of the United States Department of Health and Human Services, and the Medical Countermeasures Program, part of the United States Department of Defense. The FDA further granted a breakthrough therapy designation, a special protocol agreement, and a letter of biomarker support to NRx for NRX-101, an investigational drug to treat suicidal bipolar depression. NRX-101 is currently in phase 3 trials, with readings expected in 2022. In July 2021, the government of Israel granted NRx the exclusive worldwide right to develop and market the BriLife ™ COVID vaccine developed by the Institute. Israeli biological research.
NRx is led by executives who have held leadership positions at Allergan, J&J, Lilly, Novartis, Pfizer and the US FDA. NRx is chaired by Professor Jonathan Javitt, MD, MPH, who has held leadership positions in six start-up biotech companies with public outings and has been appointed to advisory roles in four US presidential administrations. NRx’s Board of Directors includes Dr Sherry Glied, former Assistant Secretary of Health of the United States (ASPE), Daniel E. Troy, JD, former Chief Legal Officer of the US FDA, Chaim Hurvitz, former Director of Teva and Chairman of Teva International Group, and General HR McMaster, Ph.D. (US Army, Ret.) The 26th United States National Security Advisor.
Caution Regarding Forward-Looking Statements
This announcement by NRx Pharmaceuticals, Inc. includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements regarding our outlook, product development, business outlook and market and industry trends and conditions, as well as corporate strategies, plans, objectives and goals. These forward-looking statements are based on current beliefs, expectations, estimates, forecasts and projections, as well as on assumptions made by the management of the company and on information currently available to it.
The company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise. Therefore, you should not rely on any forward-looking statements, and all forward-looking statements are qualified herein by reference to the cautionary statement.
SOURCE NRx Pharmaceuticals