NRx Pharmaceuticals Announces Launch of Emergency Use Training and Expansion of Phase 2/3 Trial of Inhaled ZYESAMI ™ (Aviptadil-Acetate) in the Nation of Georgia
RADNOR, Pennsylvania., July 6, 2021 / PRNewswire / – NRx Pharmaceuticals (Nasdaq: NRXP) (NRx), a clinical-stage biopharmaceutical company, today announced it is initiating clinical training for Nation of Georgia (Georgia) Intensive care physicians, in the use of intravenous ZYESAMI ™ (Aviptadil-acetate) for emergency use in patients with critical COVID-19, and inhaled ZYESAMI ™ for use in trials phase 2/3 clinics, for patients suffering from COVID-19.
NRx also announced that the ongoing Phase 2/3 trial for the use of inhaled ZYESAMI ™ has expanded to Georgia, with the potential to also expand to neighboring countries in the Caucasus region, in partnership with Cromos, LLC and Denk Pharma (Georgia), operating as BriLife, LLC. NRx plans to ship clinical drug supplies to Georgia in two weeks. The development of intravenous Aviptadil-acetate, in a non-GMP compliant form, was partially funded through a collaboration agreement with Relief Therapeutics (SIX: RLF, OTCBB: RLFTF).
“At NRx, we have been deeply touched by the warmth and hospitality of the people of Georgia, from the Prime Minister and the Minister of Health to the doctors and nurses on the front line fighting this deadly pandemic, which continues to rage despite great progress in vaccinations, “said Prof. Jonathan C. Javitt, MD, MPH, Chairman and CEO of NRx. “We look forward to expanding our partnership with Georgia and its inhabitants, a partnership supported by the United States Congress through its funding from Senator Richard G. Lugar Center for Public Health Research, at a time when the first deadly generations of coronaviruses (SARS and MERS) first threatened humanity . In the coming weeks, we hope to expand this partnership by Georgia, as well as with our partners at the National Institutes of Health and elsewhere. “
About ZYESAMI ™ / VIP in COVID-19
ZYESAMI ™ (Aviptadil-acetate) 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 alveolar cell type II (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 the production of surfactant, triggers the formation of inflammatory cytokines, and causes cell death. VIP has been shown to upregulate surfactant production, block coronavirus replication in the ATII cell, block cytokine synthesis, and prevent virus-induced cell death. Other than ZYESAMI ™, no currently proposed treatment for COVID-19 specifically targets this mechanism of action. ZYESAMI ™ is not approved by any regulatory authority, including the FDA and the European Medicines Agency.
About NRx Pharmaceuticals
NRx (www.nrxpharma.com) draws on more than 300 years of collective, scientific and drug development experience to improve patient health. In addition to its work on ZYESAMI ™ (Aviptadil-Acetate), the United States Food and Drug Administration has granted breakthrough therapy designation and special protocol agreement to NRx to develop NRX-101, an investigational drug to treat suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with readings expected in 2022. NRx is led by executives who have held leadership positions at Allergan, J&J, Lilly, Novartis, Pfizer and the US FDA. NRx is listed on the Nasdaq Global Select Exchange under the ticker symbol NRXP.
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 relating to our financial outlook, product development, business outlook and market and industry trends and conditions, as well as company 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 statements set forth above.
Head of Corporate Communications, NRx
SOURCE NRx Pharmaceuticals