NRx Pharmaceuticals to Lead Development of COVID-19 Medicines and Vaccines in Central Europe and the Caucasus Region in Collaboration with the Lugar Institute and Cromos Pharma
- NRx Pharmaceuticals (Nasdaq:NRXP) to collaborate with Ministries of Health of Georgia, Hungary, and Ukraine to conduct phase III development of ZYESAM™ in coordination with the Senator Richard Lugar Research Institute
- Costs of approximately $60 million to be shared by NRx and Denk Pharma, Georgia. Cromos Pharma and Denk Pharma will jointly oversee clinical development and distribution
- NRx dedicated to development of innovative medicines and vaccines for life-threatening, unmet medical needs in its mission of "Bringing Hope to Life"
- NRx expects to receive Emergency Use Authorization for ZYESAMI™ (Aviptadil acetate) to treat critically-ill patients suffering respiratory failure in Covid-19 in the face of current pandemic conditions
RADNOR, Pa., May 26, 2021 /PRNewswire/ -- Today, NRx Pharmaceuticals, Inc., (Nasdaq:NRXP) (NRx) through its Georgia subsidiary, announced that it has signed a master services agreement with Cromos Pharma, LLC, headquartered in Longview, Washington, to conduct phase 3 clinical trials of COVID-19 related drugs and vaccines in Central Europe and the Caucasus Region. The Senator Richard Lugar Research Institute, a US Government-funded regional research laboratory also serves as part of the collaboration. This region comprises a population of more than 500 million people, many of whom lack access to current COVID-19 vaccines and therapies.
"As a newly-listed Nasdaq company we are set to deliver on our plans to deliver lifesaving medicines and vaccines where none exist and fulfill our credo of "Bringing Hope to Life," said Prof. Jonathan Javitt, MD, MPH, CEO and, Chairman of the Board of NRx. "We are honored by the trust bestowed upon us by the governments and people of this region. We aim to complete our inhaled drug trial by September 2021 and to seek emergency use authorization for inhaled ZYESAMI™ from regional regulators.
NRx CEO and Chairman, Jonathan Javitt, MD, MPH met this month with the Prime Minister and Health Minister of Georgia and, with senior officials from the Ministry of Health of Ukraine to confirm final plans for the June 2, 2021 study initiation.
NRx's collaborative efforts for this initiative are led by NRx senior leaders Dr. Stephen Cunnion, MD (CAPT. MC, USN, Ret.), and Dr. Dennis McBride, PhD, (CAPT. MSC, USN, Ret., SE4 NDU, Ret.). Dr. Cunnion previously led the Defense and Intelligence communities' response to Coronavirus epidemics starting with the SARS and MERS epidemics. Dr. McBride is a former Professor of the National Defense University who previously led critical healthcare initiatives at the Potomac Institute and Defense Advanced Research Projects Agency (DARPA).
Cromos will support NRx in the development of ZYESAMI™ (Aviptadil acetate) for home treatment of COVID-19, working to reduce the incidence of hospitalization and death. In addition to the urgent human need, this initiative may reduce the current overwhelming demand for hospital resources. Cromos will further provide safety monitoring and pharmacovigilance for population-wide emergency use of intravenous ZYESAMI™ in critically-ill patients, upon approval by national ministries of health.
"The Georgia National Center for Disease Control (NCDC) and the Lugar Institute are committed to bringing the latest technology to fight the lethal effects of Coronavirus to the Caucasus Region and Central Europe. We look forward to working once again with our US colleagues in this critical initiative," said Dr. Amiran Gamkrelidze, MD Director of the NCDC and former Health Minister of Georgia.
About NRx Pharmaceuticals
NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) is a patient-focused, clinical-stage pharmaceutical company, drawing upon more than 100 years of collective medicine development experience. NRx creates therapies to treat diseases where no medicines currently exist.
NRx expects to seek Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) to treat Critical Covid-19 in patients suffering respiratory failure in May 2021. In addition, the FDA recently granted Breakthrough Therapy Designation and a Special Protocol Agreement to develop NRX-101 in suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with data readouts expected in the first half of 2022.
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Released May 26, 2021