NRx Pharmaceuticals and Hungarian Health Officials Agree on Pathway for ZYESAMI® and BriLife COVID-19 Vaccine Trials

• NRx and Hungary Agree on Regulatory Path for Emergency Use of ZYESAMI
  
• Hungary to Serve as First European Nation for the Registrational Phase 2b/3 BriLife COVID Vaccine Trial

Excerpt from the Press Release:

BUDAPEST, Hungary, Dec. 09, 2021 (GLOBE NEWSWIRE) — NRx Pharmaceuticals (NASDAQ: NRXP) today announced the conclusion of high-level meetings in Hungary that are expected to lead to utilization of ZYESAMI® (aviptadil) in that country and the pivotal clinical trial of the BriLife COVID-19 vaccine (BriLife).

Hungary will be the first European Nation to host a clinical trial site for the registrational phase 2b/3 trial of the BriLife COVID-19 vaccine. In addition to the already-developed trial protocol, NRx has been invited to submit a pediatric trial protocol that may include both injected and nasal spray administration of the vaccine. The NRx initiative in Hungary will be led by senior regulatory and academic medical leaders. Regulatory clearance for the BriLife trial is expected by the end of 2021.

Hungarian health officials have also agreed on a regulatory path for Emergency Use of ZYESAMI® (aviptadil) in the Central European region, which will start with a compassionate care program expected to begin by the end of 2021. The program is modeled on the US Food and Drug Administration’s approved Expanded Access Protocol already implemented in the United States. Confirmatory demonstration of clinical effect under this program will be submitted with safety and efficacy data in support of Emergency Use Authorization in Hungary. Europe, like much of the world, is experiencing a resurgence of COVID-19, with more than 15,000 people currently infected and more than 200 people dying in Hungary each day.

“NRx is pleased to partner with Hungary to bring two lifesaving therapies, ZYESAMI and the BriLife COVID-19 vaccine, to people in the Central European region at a time when humanity’s war against COVID is far from over,” said Prof Jonathan Javitt, MD, MPH Chairman and CEO of NRx. “We are pleased to have a positive and patient-centric working relationship with Hungarian health authorities that we believe will help prevent COVID-19 infection and serve patients who have exhausted all other approved treatments.”

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