NRx Pharmaceuticals, Inc. begins trading on Nasdaq as NRXP, following merger between NeuroRx, Inc. and Big Rock Partners Acquisition Corp (Nasdaq: BRPA)

As a Nasdaq-listed company, NRx will deploy public capital to further develop two investigational drugs: ZYESAMI ™, (Aviptadil Acetate), the first investigational drug named by the FDA as Fast Track, to be studied in patients. critically ill with respiratory COVID-19. failure, and NRX-101 (a combination drug therapy of D-cycloserine and lurasidone), the first investigational drug to receive FDA breakthrough therapy designation for patients with suicidal bipolar depression. ZYESAMI ™ has demonstrated a statistically significant increase in the likelihood of survival and recovery after respiratory failure in a phase 2b/ 3 trial (co-funded with Relief Therapeutics (SIX: RLF, OTCBB: RLFTF) on critically ill patients with COVID-19.1.2 These benefits were previously reported in an open label trial of critically ill patients at the Methodist Hospital in Houston.3 The company hopes to seek approval for the emergency use of ZYESAMI ™ from the FDA by May 2021.

NRX-101 is based on the inventions and innovation of Prof. Daniel Javitt, MD, PHD, who first explained the impact of the brain NMDA receptor in schizophrenia and other psychiatric illnesses. NRX-101 demonstrated a statistically significant benefit in maintaining remission from depression after initial treatment with ketamine in a phase 2 study.4 Currently, the only FDA-approved treatment for suicidal bipolar depression is electroconvulsive therapy.

The two investigational drugs (ZYESAMI ™ and NRX-101) are currently in phase 3 clinical trials approved by the FDA. The ZYESAMI ™ trial is being conducted by the National Institutes of Health (ACTIV3b / TESICO) in major medical centers around the world.5 A second trial is underway on the I-SPY platform with the support of the Biomedical Advanced Research Development Authority (BARDA) of the US Department of Health and Human Services. The NRX-101 test is being conducted by investigators at Harvard/ General mass, University of Alabama Birmingham, and Baylor College of Medicine.6

Jonathan javitt, MD, MPH leads NRx as CEO and Chairman of the Board. He is joined by directors and executives who have held global leadership positions in the pharmaceutical industry for decades. The directors of the company include Dr. Sherry Glied, former Assistant Secretary in the US Department of Health and Human Services, Chaim hurvitz, former president and director of Teva and Daniel Troy, former Chief Counsel of the US FDA.

NRx has committed an operating capital greater than $ 120 million from available cash, PIPE funding disclosed in the company’s S-4 file, the exercise of warrants by the Global Emerging Markets (GEM) Global Yield Fund and a stock subscription mechanism (also disclosed in S-4) supplied by GEM. Additional funds may be provided by the BRPA trust fund and through the exercise of public warrants to purchase BRPA shares (now NRXP), depending on the individual investment decisions of the trust fund holders and the holders of the shares. subscription warrants.

“NRx has been dedicated to patients whose lives depend on innovative new medicines and whose needs have not been met by the big pharmaceutical companies,” said the Honorable Sherry Glied, PhD, former assistant secretary for planning and to Evaluation at the US Department of Health and Human Services and member of the NRx Board of Directors. “The NRx leadership team draws on more than 100 collective years of pharmaceutical development, scientific and commercial expertise to bring breakthrough therapies to market.”

About NRx Pharmaceuticals

NRX Pharmaceuticals, Inc. (Nasdaq: NRXP) (NRx) is a patient-focused, clinical-stage pharmaceutical company with more than 100 years of collective medicine development experience. NRx creates therapies to treat diseases where no drugs currently exist.

NRx plans to seek emergency use authorization from the United States Food and Drug Administration (FDA) to treat critical Covid-19 in patients with respiratory failure in May 2021. In addition, the FDA recently granted breakthrough therapy designation and special protocol agreement to develop NRX-101 in suicidal bipolar depression. The NRX-101 is currently in Phase 3 trials, with data readings expected in the first half of 2022.

Caution Regarding Forward-Looking Statements

This press release contains “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 regarding our financial outlook. , product development, business prospects and market and industry trends and conditions, as well as corporate 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. Words such as “expect”, “anticipate”, “should”, “believe”, “hope”, “target”, “plan”, “objectives”, “estimate”, “potential”, “predict”, “May,” “will”, “could”, “could,” “would”, “seek”, “plan”, “intend”, “must” and variations of these terms or the negative of these terms and similar expressions are intended to identify such forward-looking statements. These forward-looking statements are, by their nature, subject to significant risks and uncertainties, many of which involve factors or circumstances beyond the control of the company. These risks and uncertainties include , but not limited to our relatively limited operating history; our ability to develop, retain and motivate our employees and manage our growth; risks associated with general industry conditions and competition; general economic factors, including including fluctuations in interest rates and exchange rates; the impact of the global epidemic of the novel coronavirus (COVID-19); the impact of pharmaceutical industry regulation and healthcare legislation United States and internationally; global trends towards containing health care costs; technological advances, new products and patents obtained by competitors; challenges inherent in developing new products, including obtaining regulatory approval; the company’s ability to accurately forecast future market conditions; manufacturing difficulties or delays; changes in laws, rules or regulations relating to any aspect of the Company’s business operations or to general economic, market and business conditions; financial instability of international economies and sovereign risk; dependence on the effectiveness of company patents and other protections for innovative products; and exposure to litigation, including patent litigation, and / or regulatory actions. In addition, there can be no assurance with respect to pipeline products that the products will receive the necessary regulatory approvals or prove to be commercially successful. If the underlying assumptions prove to be incorrect or risks or uncertainties materialize, actual results may differ materially from those stated in forward-looking statements. The company assumes no obligation and does not intend to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except if required by applicable law. As a result of these and other risks, uncertainties and assumptions, the forward-looking events and circumstances discussed herein may not occur in the manner expected by the management of the Company, if at all. Therefore, you should not rely on any forward-looking statement, and all forward-looking statements are qualified herein by reference to the cautionary statements set forth above.

Media and investor contact

Jack Hirschfield
Senior Director, External Affairs, NRx
[email protected]
512-674-5163

1 Javitt, JC, Intravenous Aviptadil for Critical COVID-19 with Respiratory Failure (COVID-AIV). Identifier NCT04311697. https://clinicaltrials.gov/ct2/show/NCT04311697
2 Youssef, JG, Lee, R, Javitt, JC, et. Al., Increased Recovery and Survival in Patients with COVID-19 Respiratory Failure After Treatment with Aviptadil: ZYESAMI COVID-19 Research Group Report # 1 (April 23, 2021). Available at http://dx.doi.org/10.2139/ssrn.3830051
3
Youssef, JG et al., VIP in the Treatment of Critical COVID-19 with Respiratory Failure in Patients with Severe Comorbidity: A Prospective Externally Controlled Trial (25 october 2020). Available at http://dx.doi.org/10.2139/ssrn.3665228
4 Nierenberg, A., and Javitt, JC (2016, November 28 – 2018, Dec 11). Sequential therapy for the treatment of severe bipolar depression. (STABIL-B). Identifier NCT02974010. https://clinicaltrials.gov/ct2/show/NCT02974010
5 Brown, S. and Neaton, J. (2021, April 14 ). ACTIV-3b: Therapeutics for Critically Ill Patients with COVID-19 (TESICO). Identifier NCT04843761. https://clinicaltrials.gov/ct2/show/NCT04843761
6 Nierenberg, A., and Javitt, JC (2016, November 28 – 2018, Dec 11). Sequential therapy for the treatment of severe bipolar depression. (STABIL-B). Identifier NCT02974010. https://clinicaltrials.gov/ct2/show/NCT02974010

SOURCE NRx Pharmaceuticals


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