Benzinga | Jan 11, 2022 07:57AM EST

NRx Announces Planned Study Investigating BriLife Booster Vaccine Against Omicron Variant

Trial targeted to begin in the first quarter of 2022 NRx is coordinating study with the US Health and Human Services Biomedical Advanced Research and Development Authority and several European * Trial targeted to begin in the first quarter of 2022

* NRx is coordinating study with the US Health and Human Services Biomedical Advanced Research and Development Authority and several European Governments

* Israel Ministry of Health has approved first-in-human trial of intradermal BriLife vaccination with the objective of enhancing immune response

* NRx continues technology transfer and scale up activities in anticipation of GMP manufacture

RADNOR, Pa., Jan. 11, 2022 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage, biopharmaceutical company, expanded on the information provided Monday at the H.C. Wainwright BioConnect Virtual Conference regarding the BriLife(tm) investigational vaccine for COVID-19.

Last week, NRx met with experts from the Israel Institute for Biological Research (IIBR) to review data and research related to the ability of the BriLife vaccine to induce neutralizing antibodies against the Omicron variant. Based on the preliminary findings, NRx is currently designing a phase 2b/3 study of the BriLife vaccine as a booster to protect against COVID-19 variants of concern including the Omicron variant. Patients in the study will be fully vaccinated with mRNA vaccines. It is anticipated that the study will begin in the first quarter of 2021 in Israel and will be expanded in coordination with the health ministries of several countries. The IIBR previously published initial serological findings documenting a neutralizing antibody response against the Delta variant that was comparable to the response against the wild-type SARS-CoV-2 virus. (JAFFE-HOFFMAN, 2021)

"We have seen the deadly impact caused by COVID-19 and its increasing number of variants, and we are eager to determine the immunity-building impact the BriLife vaccine may offer on top of that already conferred by baseline mRNA vaccination," said Prof Jonathan Javitt, MD, MPH, Chairman and CEO of NRx Pharmaceuticals. "We are working closely with the experts at the IIBR to design a study that we hope increases BriLife's accelerated path to regulatory approval."

NRx was contacted in late December by representatives of the US Department of Health and Human Services and several European Governments with a request to present Omicron findings.

In further news, the Israel Ministry of Health recently approved a study investigating the NanoPass MicronJet(tm) intradermal injection system for the BriLife vaccine. The NanoPass system, invented in Israel, uses a patented microneedle system to deliver the vaccine into the skin with minimal discomfort.

This approach is especially promising for the BriLife vaccine because it binds to angiotensin-converting enzyme 2 (ACE2) receptors, which are present in significantly larger quantities in human skin cells than in muscle cells where traditional vaccines are injected. In addition, early data with other vaccines suggests that intradermal delivery of BriLife may result in a more robust immune response at substantially lower vaccine dosing.

As these studies are moving towards initiation, NRx continues technology transfer and scale-up activities in anticipation of commercial scale manufacture by Q4 2022.