The FDA Declines EUA of Zyesami (aviptadil) for Patients with Critical COVID-19 with Respiratory Failure

It was never an impressive sample size, wouldn’t a company the size of NRx Pharmaceuticals, Inc. $NRXP know better? Something doesn’t add up here.

The stock has lost 19.5% of its value today on bearish sentiment this has caused, with $RLFTF losing 30%. This is not looking good. You had to have faith that the bigger partner and Jonathan Javitt would do what was best for the product and both parties, that doesn’t seem to have been the case. I’m starting to get a bit salty about this.

• NRx Pharmaceuticals Has Requested a Type A Meeting with US Food and Drug Administration (FDA) to Include Treating Physicians and Patients.
• It’s a huge setback, the US Food and Drug Administration (FDA) has declined to issue an Emergency Use Authorization (EUA) for ZYESAMI® (aviptadil).

Relief $RLFTF focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19.

Somehow Relief chose a partner that hasn’t honored their partnership contract or seems to have the ability to get the product approved in a timely manner.

Anyone who knows how the FDA operates knows you cannot go in there with a small sample size or not enough data. The FDA stated that it was unable to issue the EUA at this time due to insufficient data regarding the known and potential benefits of the medicine and the known and potential risks of ZYESAMI in patients suffering from Critical COVID-19 with respiratory failure. We also know the treatment is safe.

In its letter, the FDA noted that so far, it has reviewed safety in only 131 randomized patients treated with ZYESAMI. NRx will attempt to coordinate a review by the FDA of the 150 or more additional patients already treated with ZYESAMI in the NIH ACTIV-3b trial. Last week, the study’s Data Safety and Monitoring Board reviewed the ongoing NIH ACTIV-3b trial and found no new safety issues.

With the end of the worst part of the pandemic in sight, it appears Jonathan Javitt has miscalculated and the shareholders of both $NRXP and $RLFTF have taken the hit. Still the little data we have suggests that Patients treated at the nation’s top hospitals with ZYESAMI had a four-fold increase in odds of survival. So this is a great treatment for the ICU, where staffing shortages are occurring all over the world.

NRx has completed the Chemical and Manufacturing Controls (CMC) required for traditional approval pathways, we they will move towards filing for accelerated approval based on the unexpectedly strong biomarker results seen in our two clinical trials. Considering the urgency of pandemic deaths, it does not seem to have followed a reasonably rapid course.

According to NRx, ZYESAMI remains available upon a physician’s request under Federal and state Right to Try laws for those patients who meet the legal criteria for Right to Try.

• The US National Institutes of Health has enrolled more than 300 patients in the ACTIV-3b trial. a confirmatory study that randomizes patients with COVID-19 respiratory failure to ZYESAMI® vs. Veklury® (remdesivir) and placebo in a factorial design trial (NCT04843761).
• A second nationwide trial to determine if similar benefits may be achieved in critically ill patients with inhaled ZYESAMI is being conducted on the I-SPY platform, maintained by the Quantum Leap Healthcare Collaborative.

NRx also continues to study the effect of inhaled ZYESAMI in patients with severe but not critical COVID-19 in a placebo-controlled trial that aims to demonstrate the ability of ZYESAMI to keep patients from requiring intensive care.

NRx is now calling Zyesami its product in its PR statements. When this was all made possible with a partnership with Relief. NRx says its investigational product, ZYESAMI® (aviptadil) for patients with COVID-19, has been granted Fast Track designation by the US Food and Drug Administration (FDA) and is currently undergoing phase 3 trials funded by the US National Institutes of Health, the Biomedical Advanced Research and Development Authority part of the US Department of Health and Human Services, and the Medical Countermeasures program, part of the US Department of Defense.

The FDA EUA rejection is pretty clear. NRx is chaired by Prof Jonathan Javitt, MD, MPH, who has held leadership roles in six biotechnology startup companies with public exits and been appointed to advisory roles in four US Presidential Administrations really appears to have done a number on the smaller Swiss partner Relief.

The NRx board seems intent on cutting Relief out of the equation as much as possible. Such a toxic legal situation makes the stock much more risky and the prospects of both companies more uncertain.

• $NRXP is down 32% since one year ago, while $RLFTF is down 83% in the last year. Even Novavax is looking like a more promising Covid-19 stock candidate. Premarket $NRXP dipped to basically its all-time low at $5.75.

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