Benzinga | Jun 15, 2021 07:35AM EDT

NRx Pharmaceuticals Announces Positive Data Results from ZYESAMI Expanded Access Protocol

- Expanded Access Protocol (EAP) Included 240 ICU Patients Suffering Critical COVID-19 with Respiratory Failure who had Exhausted All Approved Therapies

- Sixty-Five Percent of Patients Receiving ZYESAMI(tm) (Aviptadil) and Maximal Intensive Care were Alive at 28 Days

- Survival was Higher in those Treated with High Flow Nasal Cannula than those Treated with Mechanical Ventilation (76% vs. 54%)

- Results from EAP are Congruent with the Randomized Control Phase 2b/3 ZYESAMI(tm) (Aviptadil) Trial Data Submitted to US Food and Drug Administration (FDA) in Support of Emergency Use Authorization (EUA)

- EAP Data to be Submitted to US FDA in Support of EUA Filing

NRx Pharmaceuticals (NASDAQ:NRXP), a clinical stage pharmaceutical company, today announced positive data from its ZYESAMI(tm) (Aviptadil) Expanded Access Protocol (EAP). Overall, patients receiving at least one dose of ZYESAMI(tm) in addition to intensive care were alive at 28 days. This EAP ( https://clinicaltrials.gov/ct2/show/NCT04453839) provided an opportunity for many regional hospitals to offer ZYESAMI(tm) to its sickest patients, for whom no other options were available, and who could not enroll in a study due to additional risk factors. Fifty-six percent of patients enrolled were already receiving mechanical ventilation, and 44% were receiving non-invasive forms of ventilation, mostly high nasal flow cannula. (HFNC).



NRx Pharmaceuticals Announces Positive Data Results from ZYESAMI(tm) (Aviptadil) Expanded Access Program

"We initiated the ZYESAMI(tm) EAP at FDA's request, to gain real-world evidence from patient outcomes outside of the clinical trial environment. Working with 42 U.S. medical centers and hospitals, we were able to see the outcomes ZYESAMI(tm) provided to some of sickest of COVID-19 patients," said Jonathan Javitt, MD, MPH, CEO and Chairman of the Board, of NRx. "While vaccinations have markedly reduced the incidence of COVID-19 in some countries, effective medicines remain critical for the tens of thousands who continue contracting COVID-19 and the expanding numbers of variants associated with this virus."

Enrollment in the EAP was offered to patients who were ineligible for the ZYESAMI(tm) phase 2b/3 clinical trial, and who had exhausted all approved therapies for COVID-19. The enrollment included 240 patients dosed by March 19, 2021, of whom 196 received maximal intensive care. Fifty-six patients received palliative care (withdrawal of life support) as determined by their families and treating physicians. Among patients receiving maximal intensive (i.e. non-palliative) care, 76% of those treated with HFNC were discharged from the hospital or were alive and in the hospital at day 28, compared to 54% of those treated with mechanical ventilation. These numbers are congruent with the previously reported, topline, randomized, clinical data of ZYESAMI(tm) in Critical COVID-19 patients with respiratory failure. Many of the patients involved in this EAP had prolonged illness or had exclusion factors limiting their access to the randomized clinical trial, and were enrolled as a last resort in this EAP.

Treatment related adverse events from this EAP are congruent with those seen in the randomized controlled phase 2b/3 clinical trial of ZYESMI(tm). Treatment related adverse events included diarrhea (5%) and hypotension (5%). Other adverse events included tachycardia and flushing.

"So many of us have lived the past 16 months in the ICU of our hospitals taking care of desperately-ill patients suffering from the most severe symptoms of COVID-19," said Dr. Eduardo Freitas, Head of Infectious Diseases at Great Plains Health Hospital in North Platte, Nebraska, one of the participating investigators in the EAP. "A regional hospital like ours is not typically involved in clinical studies, and we greatly appreciate the opportunity to participate in the Aviptadil EAP. Every doctor caring for COVID-19 patients needs new medicines to help those critically ill with this virus recover and get back to their homes and families."

The EAP data are being provided to FDA as "real world data", in support of the findings from the ZYESAMI(tm) randomized controlled phase 2b/3 clinical trial.