Analysis of blood samples from patients who responded to BriLifeÂ® vaccine in the Phase 2 trial suggests that the same level of response was seen against the Delta variant as compared to the original “wild-type” virus. Data Suggest BriLife Vaccine May Be Able To Evolve To Counter Delta And Other Variants Of ConcernNRx To Begin Phase 2b / 3 Registration Trial Of BriLifeÂ® Following Oversight Committee Review phase 2 data security
RADNOR, Pa., November 26, 2021 (GLOBE NEWSWIRE) – NRx Pharmaceuticals (NASDAQ: NRXP ), notes today that the Israel Institute for Biological Research (IIBR) released scientific results from an initial sample of patients vaccinated in phase 2 to assess the potential efficacy of the BriLifeÂ® vaccine against the Delta variant of SARS-CoV-2 virus. Blood (sera) from an initial sample of 11 trial participants demonstrated effective neutralizing antibodies against the original “wild-type” coronavirus and was tested for antibodies against the Delta variant. Of the eleven samples tested, ten were found to neutralize the Delta1 variant. Antibody levels are displayed in the scientific manuscript.
A second group of blood samples (sera) were taken from unvaccinated patients who contracted and recovered from Covid-19. These patients had antibodies to the âwild typeâ coronavirus but with a 3.8-fold reduction in immune response (neutralizing titers) to the Delta variant. These latter patients were not selected from a randomized controlled trial.
The IIBR scientific press release further notes that the mutations observed in the BriLife vaccine that could be responsible for the efficacy against the variants occurred naturally depending on the spontaneous acquisition of new characteristics by this live virus vaccine. The manuscript states that âspontaneously acquired mutations such as N501Y and E484D, which occurred during the development of BriLifeÂ® and correspond to natural mutations of the SARS-CoV-2 variants, may increase the potential of BriLifeÂ® to maintain its effectiveness against current SARS. variants of CoV-2, and potentially against future variants of concern. “
NRx plans to begin its Phase 2b / 3 registration trial of the BriLifeÂ® vaccine immediately after review of the Phase 2 results next week by the study’s Data Safety Oversight Committee.2
“These early results from the BriLife Phase 2 trial are very encouraging at a time when new variants of concern increasingly threaten the immunity we have built with first generation vaccines,” said Professor Jonathan Javitt, CEO and President of NRx Pharmaceuticals. âAlthough these are the first results from a subsample of patients treated in a phase 2 trial, all phase 2a patients are now more than 60 days after vaccination, and we are awaiting a review by the Independent Data Security Oversight Committee in the coming week. If the full cohort of vaccinated patients showed comparable results to this reported subgroup, it would indicate the potential effectiveness of the vaccine against new variants of the virus. “
About NRx Pharmaceuticals
NRx Pharmaceuticals (NRx) draws on more than 300 years of collective, scientific and drug development experience to improve patient health. The Company is developing the BriLifeÂ® Covid vaccine, developed by the Israel Biological Research Institute, under an exclusive license from the Israeli Ministry of Defense. NRx is further developing ZYESAMIÂ® (aviptadil) for patients with COVID-19, and has received Fast Track designation by the United States Food and Drug Administration (FDA), and is currently in phase trials. 3 funded by the United States National Institutes of Health, the Biomedical Advanced Research and Development Authority (BARDA) of the United States Department of Health and Human Services, and the Medical Countermeasures Program, which is part of the United States Department of defense. The FDA further granted a breakthrough therapy designation, a special protocol agreement, and a letter of biomarker support to NRx for NRX-101, an investigational drug to treat suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with readings expected in 2022. NRx is led by executives who have held leadership positions at Allergan, J&J, Lilly, Novartis, Pfizer and the US FDA. NRx is chaired by Professor Jonathan Javitt, MD, MPH, who has held leadership positions in six start-up biotech companies with public outings and has been appointed to advisory roles in four US presidential administrations. NRx’s board of directors includes Dr Sherry Glied, former US Assistant Secretary of Health (ASPE), Daniel E. Troy, JD, former US FDA legal counsel, Chaim Hurvitz, former director of Teva and Chairman of Teva International Group; and General HR McMaster, Ph.D. (US Army, Ret.) the 26th United States National Security Advisor.
Caution Regarding Forward-Looking Statements
This announcement by NRx Pharmaceuticals, Inc. includes “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 outlook, product development, business outlook 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 to the company.
The company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise. Therefore, you should not rely on any forward-looking statements, and all forward-looking statements are qualified herein by reference to the cautionary statements set forth above.
MEDIA CONTACT: Jack Hirschfield Head of Corporate Communications, NRx [email protected] 512-674-5163
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SOURCE NRx Pharmaceuticals