NRx Pharmaceuticals Announces Initiation of Emergency Use Training and Extension of Phase 2/3 Inhaled ZYESAMI™ (Aviptadil-acetate) Trial in the Nation of Georgia

Rhea-AI Summary

NRx Pharmaceuticals (Nasdaq: NRXP) announced the initiation of clinical training for ICU physicians in Georgia on using intravenous ZYESAMI™ (Aviptadil-acetate) for emergency COVID-19 treatment. Additionally, the ongoing phase 2/3 trial for inhaled ZYESAMI™ will be extended to Georgia and potentially neighboring countries. Clinical drug supplies are expected to ship within two weeks. The partnership is partially funded through Relief Therapeutics. ZYESAMI™ aims to address COVID-19-related respiratory failure by targeting cellular mechanisms affected by the virus.

Positive

• Initiating clinical training for ICU physicians in Georgia.
• Ongoing phase 2/3 trial for inhaled ZYESAMI™ extended to Georgia.
• Clinical drug supplies expected to ship within two weeks.

Negative

• ZYESAMI™ is not approved by any regulatory authority, including the FDA.

RADNOR, Pa., July 6, 2021 /PRNewswire/ -- NRx Pharmaceuticals (Nasdaq: NRXP) (NRx), a clinical stage biopharmaceutical company, today announced it is initiating clinical training of Nation of Georgia (Georgia) ICU physicians, in the use of intravenous ZYESAMI™ (Aviptadil- acetate) for emergency use in patients suffering with Critical COVID-19, and inhaled ZYESAMI™ for use in phase 2/3 clinical trials, for patients suffering with COVID-19.

NRx also announced that the ongoing phase 2/3 trial for the use of inhaled ZYESAMI™ has extended to Georgia, with the potential to also extend to neighboring countries in the Caucasus region, in partnership with Cromos, LLC and Denk Pharma (Georgia), operating as BriLife, LLC. NRx expects to ship clinical drug supplies to Georgia within two weeks. The development of intravenous Aviptadil-acetate, in non-GMP form was partially-funded by a collaboration agreement with Relief Therapeutics (SIX:RLF, OTCBB:RLFTF).

"We at NRx have been deeply touched by the warmth and hospitality extended by the people of Georgia, from the Prime Minister and the Minister of Health to the front-line doctors and nurses who are battling this lethal pandemic, that continues to rage despite great progress with vaccinations," said Prof. Jonathan C. Javitt, MD, MPH, Chairman and CEO of NRx. "We look forward to our expanding partnership with Georgia and its people, a partnership supported by the US Congress through its funding of the Senator Richard G. Lugar Center for Public Health Research, at a time when the first lethal generations of Coronavirus (SARS and MERS) first threatened humanity. In the coming weeks, we hope to broaden this partnership in 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 lung, it was first purified from the intestinal tract. VIP binds specifically to the alveolar type II 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 respiratory distress, acute lung injury, and inflammation. Most importantly, VIP stimulates ATII cells to make the surfactant that must coat the lining of the lungs in order for them to exchange oxygen with the blood.  Loss of surfactant causes respiratory failure and alveolar collapse, which are hallmarks of COVID-19.

COVID-19-related respiratory failure is caused by selective infection of the ATII cell by the SARS-CoV-2 virus. The ATII cells are vulnerable because of their (ACE2) surface receptors, which serve as the route of entry for the virus. Coronavirus infection of the ATII cell shuts down surfactant production, triggers the formation of inflammatory cytokines, and causes cell death. VIP is shown to upregulate surfactant production, block Coronavirus replication in the ATII cell, block cytokine synthesis, and prevent viral-induced cell death. Other than ZYESAMI™, no currently proposed treatments for COVID-19 specifically target this mechanism of action. ZYESAMI™ is not approved by any regulatory authority, including the FDA and European Medicines Agency.

About NRx Pharmaceuticals

NRx (www.nrxpharma.com) draws upon more than 300 years of collective, scientific and drug-development experience to bring improved health to patients. In addition to its work on ZYESAMI™ (Aviptadil-Acetate), the United States Food and Drug Administration has granted Breakthrough Therapy Designation and a Special Protocol Agreement to NRx to develop 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 publicly traded on the Nasdaq Global Select Exchange under the stock ticker NRXP.

Cautionary Note Regarding Forward-Looking Statements

This announcement by NRx, Pharmaceuticals, Inc. includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. 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. 

CORPORATE CONTACT

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

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SOURCE NRx Pharmaceuticals

FAQ

What is the purpose of the clinical training in Georgia for ZYESAMI™?

The training is aimed at ICU physicians for the emergency treatment of COVID-19 patients using intravenous ZYESAMI™.

What is the status of the phase 2/3 trial for inhaled ZYESAMI™?

The trial has been extended to Georgia and may expand to neighboring countries.

What is ZYESAMI™ and how does it work against COVID-19?

ZYESAMI™ (Aviptadil-acetate) targets respiratory failure by increasing surfactant production and blocking viral replication in lung cells.

What are the implications of ZYESAMI™ not being approved by any regulatory authority?

The lack of regulatory approval means that ZYESAMI™ is not yet available for widespread use, limiting its market potential and investor confidence.

When are the clinical drug supplies expected to ship to Georgia?

Clinical drug supplies are expected to be shipped within two weeks from the announcement.