ZYESAMI Cleared to Complete Full Enrollment for Critical COVID-19 Patients

Pennsylvania-based NRx Pharmaceuticals today announced the results of a ZYESAMI® review conducted by the Therapeutics and Prevention Data Safety and Monitoring Board (DSMB) of the U.S. National Institute of Allergy and Infectious Diseases (NIAID) on February 14, 2022.

The DSMB reviewed data on 448 ICU patients with Critical COVID-19 Respiratory Failure enrolled in the ACTIV-3b (TESICO) trial.

According to a U.S. NIH spokesperson, aviptadil is the sole remaining investigational medicine offered within the ACTIV-3 trial, targeting the most critically-ill patients with COVID-19.

'While the continuation of this trial certainly does not guarantee success in proving the primary endpoint, NRx is encouraged to reach this level of enrollment without identifying either a safety or futility stopping point,' wrote NRx in the press release issued on February 15, 2022.

NRx further confirmed that it has received no reports of drug-related Serious Adverse Events from the NIH and is forwarding this safety information to the U.S. FDA for inclusion in its ongoing review.

These findings increase the safety database of patients treated with ZYESAMI to more than 800 patients.

Prof. Jonathan Javitt, MD, MPH, Chairman and CEO of NRx, commented in today's press statement, "So far, we have received no reports of drug-related Serious Adverse Events in ZYESAMI-treated patients and are sharing those data with the FDA."

"We are indebted to the NIH leadership for its decision to include our investigational medicine in the ACTIV program alongside investigational medicines from major pharmaceutical companies and hope that ZYESAMI will soon become an important therapeutic option that enables physicians to offer a renewed chance at life to patients who have exhausted all approved therapies."

The FDA previously cleared the TESICO protocol as a Phase 3 trial that, if positive, may be used in the submission of a New Drug Application.

Zyesami (Aviptadil) is a synthetic human Vasoactive Intestinal Peptide formulation, which was discovered in 1970.