Skip to main content

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

Written by Customer Service on . Posted in Public Companies.

  • 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

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.”

About NRx Pharmaceuticals

NRx Pharmaceuticals (NRx) draws upon more than 300 years of collective, scientific, and drug-development experience to bring improved health to patients. In July 2021, the Government of Israel awarded NRx the exclusive worldwide right to develop and market the BriLife™ COVID vaccine developed by the Israel Institute for Biological Research. NRx continues to develop ZYESAMI® (aviptadil) for patients with COVID-19, which has been granted Fast Track designation by the US Food and Drug Administration (FDA) and is currently undergoing phase 3 trials funded by the US National Institutes of Health, the Biomedical Advanced Research and Development Authority (BARDA) of the US Department of Health and Human Services, and the Medical Countermeasures program, part of the US Department of Defense. The FDA has additionally granted Breakthrough Therapy Designation, a Special Protocol Agreement, and a Biomarker Letter of Support to NRx for 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 chaired by Prof Jonathan Javitt, MD, MPH, who has held leadership roles in medical technology companies with public exits and been appointed to advisory roles in four US Presidential Administrations. The NRx board includes Dr. Sherry Glied, former US Assistant Secretary for Health (ASPE), Daniel E. Troy, JD, former Chief Counsel of the US FDA, Chaim Hurvitz, former director of Teva and President of the Teva International Group, and General H.R. McMaster, Ph.D. (US Army, Ret.) the 26th United States National Security Advisor.

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 US 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.

MEDIA CONTACT:
Jack Hirschfield
Head of Corporate Communications, NRx
jhirschfield@nrxpharma.com
512-674-5163

INVESTOR RELATIONS
Eric Goldstein
LifeSci Advisors
egoldstein@lifesciadvisors.com
646-791-9729

SOURCE: NRx Pharmaceuticals

Disclaimer & Cookie Notice

Welcome to GOLDEA services for Professionals

Before you continue, please confirm the following:

Professional advisers only

I am a professional adviser and would like to visit the GOLDEA CAPITAL for Professionals website.

Important Notice for Investors:

The services and products offered by Goldalea Capital Ltd. are intended exclusively for professional market participants as defined by applicable laws and regulations. This typically includes institutional investors, qualified investors, and high-net-worth individuals who have sufficient knowledge, experience, resources, and independence to assess the risks of trading on their own.

No Investment Advice:

The information, analyses, and market data provided are for general information purposes only and do not constitute individual investment advice. They should not be construed as a basis for investment decisions and do not take into account the specific investment objectives, financial situation, or individual needs of any recipient.

High Risks:

Trading in financial instruments is associated with significant risks and may result in the complete loss of the invested capital. Goldalea Capital Ltd. accepts no liability for losses incurred as a result of the use of the information provided or the execution of transactions.

Sole Responsibility:

The decision to invest or not to invest is solely the responsibility of the investor. Investors should obtain comprehensive information about the risks involved before making any investment decision and, if necessary, seek independent advice.

No Guarantees:

Goldalea Capital Ltd. makes no warranties or representations as to the accuracy, completeness, or timeliness of the information provided. Markets are subject to constant change, and past performance is not a reliable indicator of future results.

Regional Restrictions:

The services offered by Goldalea Capital Ltd. may not be available to all persons or in all countries. It is the responsibility of the investor to ensure that they are authorized to use the services offered.

Please note: This disclaimer is for general information purposes only and does not replace individual legal or tax advice.