As reported last night in the Times of Israel, the former Director of the Israel Institute for Biological Research (IIBR) disclosed that the BriLife™ Vaccine has shown initial signs of effectiveness against the Omicron variant.
This is the information that caused NRx to advise the public that we are moving towards a vanguard trial of BriLife as a booster vaccination for people who previously received mRNA vaccines. We are advised that the scientific data will be released sometime next week.
The important part is not so much that BriLife demonstrated effectiveness against Omicron. The virus is mutating more rapidly than the more familiar influenza viruses, and changing the way it looks inside our bodies, how sick it makes us and how it changes the way we fall ill. The key issue from our perspective is that Omicron looks very different to the immune system than the original virus. Recent studies in Israel and elsewhere have demonstrated disappointing results when repeated mRNA vaccination (i.e., a fourth mRNA vaccination) was tried in the face of the Omicron surge.
We know, for example, that the Delta variant made many very sick and infected a person’s entire respiratory system. We then quickly saw the Omicron variant sweep across our world and become the dominant variant. While it did not cause the same level of severe illness in the majority of people, we now know Omicron is significantly more transmittable than any other mutation of the virus and that the Omicron variant infects people much easier than the original wildtype virus or COVID-19 mutations that have infected humans since the late part of 2019.
At NRx, we continue to keep up with how mutations of the COVID-19 virus and its mutations impact human health.
The news of BriLife’s effectiveness comes from Dr. Shmuel Shapira, the former Director of the IIBR, NRx’s partner in developing the BriLife vaccine. As with many important data regarding vaccine and medicine development, the complete and detailed information is expected to be published in a scientific journal in the coming weeks.
NRx continues to work with the IIBR to design a Phase 3 trial to test the BriLife vaccine as a booster https://www.nrxpharma.com/ceo-update-brilife-investigational-vaccine-for-covid-19-as-a-booster/ and looks forward to generating important data that may show a different and more comprehensive level of protection against COVID-19 and its variants.
As always, I will continue to share information as it becomes available and provide updates about our efforts to bring the BriLife vaccine to the market and information about our other investigational medicines and their ability to protect us from illness and help us regain our health.
As always, thank you for following our journey.
Jonathan
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. The Company is developing the BriLife™ Covid vaccine, developed by the Israel Institute for Biological Research, under an exclusive license from the Israel Ministry of Defense. NRx is additionally developing ZYESAMI® (aviptadil) for patients with COVID-19, and 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 six biotechnology startup 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.
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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.
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