Clinical-stage pharmaceutical company NRx Pharmaceuticals Inc. (NRXP:NASDAQ), which is focused on creating and developing life-saving treatments for medical conditions and diseases with no approved therapies or cures, announced 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."
The company noted that in 10 of the 11 tested samples collected during the Phase 2 study, the BriLife® vaccine was shown to have effectively neutralized the Delta variant.
The firm indicated further that additional blood samples (sera) had been drawn from a second group of non-randomized, unvaccinated patients who had contracted and recovered from Covid-19. NRx Pharmaceuticals stated that "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."
The company explained that BriLife® is a live-virus vaccine and that the scientific data released by the IIBR suggests that "mutations seen in the BriLife vaccine may be responsible for effectiveness against variants occurred naturally as a function of the spontaneous acquisition of new characteristics."
NRx Pharma elaborated that according to the manuscript prepared by the IIBR, "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."
The company indicated that this week the study's Data Safety Monitoring Board will be performing a full review of the Phase 2 results. The firm stated that after the reviews is completed it intends to proceed immediately with commencement of a Phase 2b/3 registration trial of the BriLife® vaccine.
NRx Pharmaceuticals' CEO and Chairman Prof. Jonathan Javitt commented, "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…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."
NRx Pharmaceuticals is a clinical-stage pharmaceutical company headquartered in Radnor, Pa. The firm is presently involved in advancing the BriLife® Covid vaccine, which it said was developed by the Israel Institute for Biological Research, under an exclusive license from the Israel Ministry of Defense.
In addition, the company is also conducting Phase 3 trials for ZYESAMI® (aviptadil) to treat respiratory failure in patients with COVID-19. The firm noted that ZYESAMI® (aviptadil) has been awarded Fast Track designation by the U.S. Food and Drug Administration (FDA) and advised that the "Phase 3 studies are being funded by the U.S. National Institutes of Health, the Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services and the Medical Countermeasures program, part of the U.S. Department of Defense."
The company has also been granted Breakthrough Therapy Designation for its NRX-101, an oral therapeutic for use in treating acute suicidal behavior/ideation in bipolar depression. The firm indicated that NRX-101 is currently being evaluated in Phase 3 trials with data readouts expected in 2022.
NRx Pharmaceuticals started off the day on Friday with a market capitalization of around $264.6 million with approximately 58.81 million shares outstanding. NRXP shares opened about 3.00% higher at $4.62 (+$0.12, +2.67%) over the prior trading day's $4.50 closing price. The stock traded Friday between $4.3979 and $8.89 per share and closed for trading at $6.75 (+$2.25, +50.00%).
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