Analysis of Blood Samples from Patients who Responded to the BriLife® Vaccine During Phase 2 Trial Suggests that the Same Level of Response was Seen Against the Delta Variant as Against the Original “Wild-Type” Virus
Data Suggest that the BriLife Vaccine May Be Capable of Evolving to Counter Delta and Other Variants of Concern
NRx to Commence Phase 2b/3 Registration Trial of BriLife® After Upcoming Phase 2 Data Safety Monitoring Board Review
RADNOR, Pa., Nov. 26, 2021 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals (NASDAQ: NRXP), today notes that the Israel Institute for Biological Research (IIBR) has posted scientific results from an initial sample of phase 2 vaccinated patients in order to assess the potential effectiveness of the BriLife® vaccine against the Delta variant of the 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 to the Delta variant. Of the eleven tested samples, ten were found to neutralize the Delta variant1. The antibody levels are displayed in the scientific manuscript.
A second group of blood samples (sera) were drawn from unvaccinated patients who contracted and recovered from Covid-19. Those patients had antibodies against the “wild-type” 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 release further notes that mutations seen in the BriLife vaccine that may be responsible for effectiveness against variants occurred naturally as a function of the spontaneous acquisition of new characteristics by this live-virus vaccine. The manuscript states that “spontaneously-acquired mutations such as N501Y and E484D, that occurred during BriLife® development and correspond to naturally-occurring mutations of SARS-CoV-2 variants, may increase the potential of BriLife® to maintain effectiveness against current SARS-CoV-2 variants, and potentially against future variants of concern.”
NRx expects to commence its Phase 2b/3 registration trial of the BriLife® vaccine immediately after review of the phase 2 results next week by the study’s Data Safety Monitoring Board.2
“These early findings from the BriLife phase 2 trial are highly encouraging at a time when new variants of concern increasingly threaten the immunity we have built with first-generation vaccines,” said Prof. Jonathan Javitt, CEO and Chairman of NRx Pharmaceuticals. “Although these are early results from a subsample of patients treated in a phase 2 trial, all phase 2a patients are now more than 60 days post-vaccination, and we await a review by the independent Data Safety Monitoring Board in the coming week. Should the full cohort of vaccinated patients demonstrate results comparable to this reported subgroup, that would be indicative of potential vaccine effectiveness against new variants of the virus.”
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.
Cautionary Note Regarding Forward-Looking Statements
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.
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.
Head of Corporate Communications, NRx
SOURCE NRx Pharmaceuticals