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NRx Announces Completion of Data Safety Meeting for Phase 2 Trial of BriLife Vaccine, Phase 2b/3 Registration Trial to Begin in Nation of Georgia, Israel, European Union, and Other Regions
Independent Data Safety Monitoring Board has completed review of BriLife phase 2 trial at low, medium, and high doses, with a formal report expected
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"Independent Data Safety Monitoring Board has completed review of BriLife phase 2 trial at low, medium, and high doses, with a formal report expected imminentlyNRx has obtained advice from European Medicines Authority and World Health Organization on phase 2b/3 registration trial protocolMore than 10 countries have reached out to express interest in participation RADNOR, Pa., Dec. 06, 2021 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals (NASDAQ: NRXP), today was advised that the independent Data Safety Monitoring Board overseeing the phase 2 trial of the BriLife™ vaccine has concluded its safety analysis. A formal report is expected in the coming days. Based on the input received, NRx is proceeding with its plans to initiate a phase 2b/3 registration trial of BriLife (see www.clinicaltrials.gov NCT04990466). NRx, working in concert with Cromos, LLC has received guidance in design of the trial from the European Medicines Agency and the World Health Organization. The BriLife 002 phase 2b/3 trial is expected to commence in Israel and the Nation of Georgia, with European and North American countries to be added once the initial phase 2b volunteers have been vaccinated. The trial configuration will be a non-inferiority design comparing BriLife to an already approved vaccine. Interest from potential national participants in the trial design has been elevated by recently-released early data suggesting that BriLife has the potential to generate antibody responses to the Delta variant of the Coronavirus. Laboratory studies of antibody response to the Omicron variant are underway. In contrast to first-generation vaccines against COVID, BriLife is a viral vector vaccine that presents the entire spike protein complex of the Coronavirus to the body’s immune system and is able to present multiple variants of the spike protein simultaneously. NRx believes that this will potentially equip BriLife to create a more robust immune response than vaccines that present only a single variant of the spike protein or even a portion of a single variant to the immune system. Unlike other vaccines, BriLife binds to the specific cells in the lung and nasal cavity that are targeted by the Coronavirus. This creates a potential for the vaccine to create a level of tissue immunity that may prevent vaccinated individuals from contracting and spreading new variants of COVI...