NeuroRx reports mixed results for drug that treats critical Covid cases

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Neuro RX
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NeuroRx, Inc. reported  a mixture of results on a drug used to treat critically ill coronavirus patients. 

NeuroRx is headquartered in Wilmington and has laboratory facilities in Radnor, PA.

The study showed that patients who were treated with the maximal standard of care plus the company’s Zyesami were discharged sooner from the hospital compared to those treated with placebo and a maximum  standard of care.

However, with the improvement in survival rates since the start of the Covid-19 pandemic, differences in patient survival were not seen at day 28, and patients are now being followed through day 60. 

If authorized for use, Zyesami would be the first drug indicated specifically for Covid-19 patients who are critically ill with respiratory failure. 

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Jonathan Javitt, M.D., CEO of NeuroRx, said: “We are greatly encouraged by these preliminary findings and believe they are indicative of a biologic effect of aviptadil in hastening recovery from Critical Covid-19. We expect to discuss with the Food and Drug Administration and other regulatory authorities the submission of an Emergency Use Authorization   so that Zyesami can be available for treating this population that is at immediate risk of death and for which there is no approved therapy.” 

Data  are expected within a few weeks and will provide further insight into the benefits of Zyesami.

Javitt continued: “The data provide preliminary support for Zyesami as a drug that may help get critically-ill patients home to their families sooner.  The hospitalization data further suggest that patients treated at an earlier stage of illness (i.e., those who can be managed with HFNC) may have a better response to treatment.”

A  phase 2/3 trial to explore Zyesami’s inhaled use in patients who are not yet in respiratory failure.  

Dr. Javitt concluded,  “We are forever indebted to the study coordinators, nurses, respiratory therapists, and doctors who carried out this study in the midst of a public health calamity that so far has claimed the lives of nearly half a million Americans and millions worldwide.  Our study teams kept the effort going despite contracting COVID themselves, losing family members, and dealing with an unimaginable daily reality. 

The data were generated in multicenter clinical trial whose subjects were Covid-19 patients with respiratory failure being treated with the maximal standard of care that included anti-coagulants, steroids, convalescent plasma and antiviral drugs. 

A total of 203 patients were screened and consented to participate in the study; 136 were given Zyesami. while 67 received the standard of care. 

Under the trials, a total of 138 patients (91 Zyesami, 47 (standard of care) survived through day 28. Ninety-six patients (65 Zyesami, 31 (standard of care) were discharged from the hospital by day 28. Data analysis is ongoing.

Late last year, Big Rock Partners Acquisition Corp., a special purpose acquisition company, entered into a plan of merger with NeuroRx, Inc.

NeuroRx also has a bipolar depression drug in development. 

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