NRx Aims to Bring Zyesami to Market Based on Real-World Data in Treating Seriously Ill COVID-19 Patients

COVID-19 infection rates are declining following the latest surge driven by the Omicron variant. Despite the falling infections, the virus is expected to remain an endemic concern and can still pose a serious threat, particularly to those who are not vaccinated.

For Jonathan Javitt, Chief Executive Officer of NRx Pharmaceuticals, the company’s experimental COVID-19 treatment aviptadil, which will be known by the trade named Zyesami, can play a key role in saving the lives of those patients who are seriously ill and have failed to respond to Gilead Sciences’ antiviral drug, Remdesivir.

“We’ve had enough experience with the drug to know that it has the potential to save lives in a very dramatic way,” Javitt said.

In a conversation with BioBuzz, Javitt explained that the story of Zyesami can best be seen in the Real World data that has come from severely ill patients who have been allowed to be treated with the medication under the federal Right to Try laws.

It all started with one phone call and one patient, he said.

Javitt, who is also an adjunct professor at Johns Hopkins and a former health care and biodefense advisor to the White House, said he received a call from a member of Congress seeking any help for a constituent who was critically ill with COVID-19. The patient had been in the intensive care unit and on a mechanical ventilator for more than two weeks. The hospital had already conducted an end-of-life conference with the patient’s spouse. The congressman asked for use of Zyesami under Right to Try. After working with the hospital, Javitt said the medication was administered to the patient whose oxygen levels were “as low as they could be.”

One day after the patient was treated, Javitt said her blood oxygen level had improved by 30%. A week after treatment with Zyesami, she was down to minimum oxygen requirements and is now in rehabilitation and expected to go home, he said.

That’s not the only positive result In Texas, 17 of 19 COVID-19 patients treated with the medication under the Right to Try program have recovered and have since returned to their families.

“There’s no question that the drug is associated with improved survival,” Javitt said.

Zyesami is a long-term stable form of vasoactive intestinal peptide. It is currently in a Phase 3 study funded by the National Institutes of Health. In clinical studies, NRx’s Zyesami was shown to be associated with a two-fold increased odds of survival at 60 days, according to company data. However, some data is showing even higher survival rates. In January, the company submitted data to the U.S. Food and Drug Administration showing patients who failed to recover on Remdesivir and were later treated with Zyesami had a three-fold increased chance of recovery from the ICU and a four-fold increase of survival after 60 days.

Javitt explained that unlike other drugs aimed at the virus, which include monoclonal antibodies and antiviral treatments like Remdesivir or Pfizer’s Paxlovid, Zyesami is not intended to combat COVID-19 itself. Rather, it targets the injury to the lungs caused by acute respiratory distress syndrome, which is associated with COVID-19.

“Our drug doesn’t care if you have respiratory failure from any particular variant. The drug treats the injury and is less focused on whichever variant caused the injury,” Javitt said. However, he noted that “the fact we can get people out of the ICU and home to their loved ones doesn’t mean their lungs aren’t damaged.” Those patients could still have some long-term issues associated with the infection.

“The COVID pandemic made this possible to bring this drug to the clinic. We believe it’s the first drug that heals the lining of the lung,” he said.

As Pennsylvania-based NRx continues to move Zyesami forward in the clinic, the company is embroiled in a lawsuit against its former developmental partner Relief Therapeutics, which is based in Switzerland. Javitt referred to the lawsuit as a contract dispute. He said the dispute is over funding that NRx believes Relief owes to cover the costs of the drug’s development.

“The dispute with Relief has nothing to do with the benefits of the drug,” Javitt said.

The Real World Evidence the company has collected through Right to Try could be used as potential data to support Emergency Use Authorization of Zyesami, Javitt said. He noted that the language that was used to give the FDA the authority to use EUA for experimental drugs gives weight to such evidence beyond controlled clinical trials. Javitt pointed to the use of convalescent plasma and hydroxychloroquine as treatments that had been authorized due to Real World Evidence, only to have that authorization withdrawn once more clinical data was available.

“EUA isn’t like a New Drug Approval. It’s not expected to be 100% in the middle of a catastrophe like COVID-19. You’ll never have all the data you want, but you have to protect the population,” Javitt said.