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.
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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
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