Aviptadil has gone 0 for 2 on emergency use authorization filings at the FDA. The new rejection is the latest in a series of blows to the COVID-19 candidate, driving NRx Pharmaceuticals to shift focus to its bipolar depression prospect.
NRx Pharmaceuticals has reported that the Data Safety and Monitoring Board (DSMB) of the ACTIV-3b (TESICO) clinical trial recommended halting analysis of Zyesami (aviptadil) in critical Covid-19 patients due to futility.
There goes another one. After a who’s who of biopharmas failed the National Institutes of Health's (NIH’s) inpatient COVID-19 study, NRx Pharmaceuticals has now flunked a related trial in severely ill patients, sending its share price down to the basement.
SAN FRANCISCO, March 31, 2022 /PRNewswire/ -- Quantum Leap Healthcare Collaborative (QLHC) announced in collaboration with NRx Pharmaceuticals, Inc. (NRx), that the nebulized form of ZYESAMI® (Aviptadil), in the I-SPY COVID Trial of Critical COVID-19 patients has been stopped. The I-SPY COVID Trial, (NCT04488081) is a phase 2, open label, adaptive platform trial designed to rapidly screen potential agents that could substantially improve treatment for severely and critically ill COVID-19 patients. QLHC is the sponsor of the I-SPY COVID TRIAL. The trial is structured to identify those agents with a big impact, those that could have the potential to reduce the time to recovery (defined as reduction in oxygen demand) by approximately 50% or risk of mortality in critically ill COVID-19 patients.
RADNOR, Pa., Jan. 18, 2022 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals (Nasdaq: NRXP) today announced enhancements to its Expanded Access and Right to Try programs. The programs enable patients with respiratory failure from COVID-19, who have tried all approved medicines, including remdesivir, and who are not able to participate in a clinical study, to receive ZYESAMI® (aviptadil) upon a physician’s prescription.
NRx Pharmaceuticals has filed a new breakthrough therapy designation (BTD) request for its therapy Zyesami (aviptadil) in Covid-19 patients.