NRx Weekly Newsletter: January 28, 2022
|
|
At NRx, we focus on developing medicines and a vaccine to help some of the sickest patients return home to their families and prevent people from contracting the COVID-19 virus.
Each week we work in large and small ways to advance our efforts around the world, and it’s our goal to update those interested in our journey about the details surrounding those efforts.
We will send out a summary of NRx’s efforts and activities for the week to update you on our efforts and our patient focus. We hope you find it helpful in following our company’s journey.
Thank you,
Jonathan
NRx Receives Initial Report of Patient Safety and Survival from Right to Try Use of ZYESAMI® (aviptadil) During Omicron Surge
On Wednesday, information that a Southwestern U.S. hospital reported safety data, collected under the Federal Right to Try laws, indicated that 16 of 19 patients (84%) with COVID-19 respiratory failure were treated with ZYESAMI® (aviptadil) by December 31, 2021, have survived the ICU.
The report included the following information:
- No serious adverse events were reported
- Patients were treated during the Omicron Surge
- Patients were treated at the first onset of respiratory failure after exhausting remdesivir and other approved therapies
- NRx is providing the data collected from the hospital to the FDA in support of the ongoing application for Emergency Use Authorization
These patients were treated under the Federal Right to Try law that gives access to investigational medicines for patients diagnosed with life-threatening diseases or conditions, who have tried all approved treatment options, and who cannot participate in a clinical trial to access certain unapproved treatments.
NRx will continue to update the safety information collected under the Right to Try law on an ongoing basis, and the data received from hospitals and patients treated under the Right to Try law do not involve a control group and are not part of a research study designed to test efficacy.
ZYESAMI continues to be tested in the ongoing U.S. National Institutes of Health-sponsored ACTIV-3b (TESICO) trial that has now accrued two-thirds of its targeted enrollment.
NRx Announces Publication of Initial Findings of BriLife® Vaccine-Produced Antibodies Against Omicron Variant
On Thursday, NRx received scientific evidence from the Israel Institute for Biological Research (IIBR) that the BriLife® vaccine may produce effective levels of neutralizing antibody against the Omicron variant of the SARS-CoV-2 virus. More importantly, many of the mutations that cause the Omicron variant have been identified in the spike protein of the BriLife vaccine. This natural evolution of the BriLife vaccine suggests that the vaccine may continue to evolve to address future COVID-19 Variants of Concern (VOCs).
Unlike the current mRNA vaccines and attenuated virus vaccines, the BriLife vaccine is a live, viral vector vaccine in which the spike protein of the SARS-CoV-2 virus has been added to a benign virus.
The findings are based on blood samples (sera) of patients vaccinated during the Phase 2 BriLife trial conducted in Israel. These data indicated a mean neutralization titer (NT50) of 53 against Omicron vs. a titer of 152 against the original wild-type virus and 131 against the Delta variant. This 3-fold change against the wild-type virus may be compared to the 20-fold decrement associated with mRNA vaccines. The IIBR report documents that 10 of 13 tested sera demonstrated clinically detectable levels of Omicron-neutralizing antibody.
The IIBR report concludes, “Taken together, our data indicate that BriLife-induced antibodies maintain neutralizing potential against all tested variants, and most importantly against Delta, and the recently emerged Omicron VOCs. We suggest that spontaneously-acquired mutations that occurred during BriLife® development and corresponded to naturally-occurring mutations of SARSCoV-2 variants may increase the potential of BriLife® to maintain effectiveness against current SARS-CoV-2 variants, and potentially against future VOCs.”
|
|
|
|
