NRx Pharmaceuticals Notes New Data on BriLife COVID-19 Vaccine Effectiveness Against Delta Variant Posted by Israel Institute for Biological Research

• 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.”