NRx Pharmaceuticals' experimental Covid-19 therapy fails in late-stage testing; stock price nose-dives
NRx Pharmaceuticals' stock price plummeted Thursday.
Yuichiro Chino | Getty Images
By John George – Senior Reporter, Philadelphia Business Journal
May 26, 2022
NRx Pharmaceuticals' stock opened down 40% Thursday after study results torpedoed hopes for its experimental Covid-19 therapy.
The Main Line biopharmaceutical company announced an independent Data Safety and Monitoring Board overseeing a clinical study of NRx's experimental Covid-19 therapy Zyesami determined the evaluation of the drug candidate should "cease due to futility."
The clinical trial sponsored by the National Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health, was evaluating Zyesami as a potential treatment for patients with critical Covid-19 respiratory failure.
The monitoring board reviewed data for about 460 patients, 75% of the target enrollment of 640 patients, most of whom had reached the study's 90-day endpoint. The data showed the treatment did not achieve the desired effectiveness measures related to patient status. The group receiving Zyesami had a 37% mortality rate, while those receiving a placebo had a 36% mortality rate.
Radnor-based NRx (NASDAQ: NRXP) twice tried to get emergency use authorization for Zyesami from the Food and Drug Administration without success.
The company's stock was trading down 58% at 57 cents per share in mid-morning trading Thursday.
“We thank the NIH and the trial leadership for its extensive work in studying Zyesami," said Robert Besthof, Interim CEO of NRx Pharmaceuticals, in a statement. "We will continue to work closely with them to better understand the data over the coming months. This will also enable us to evaluate the options for Zyesami in protecting the lung in other respiratory disorders, as well as its potential in other therapeutic areas.”
Zyesami is a patented, synthetic formulation of human vasoactive intestinal peptide, which was discovered in 1970 and is produced throughout the body — primarily concentrated in the lungs. Versions of vasoactive intestinal peptide have been used to treat various inflammatory conditions, such as acute respiratory distress syndrome, asthma and chronic obstructive pulmonary disease.
Besthof said the focus of NRx will continue to be "applying innovative science" to known molecules in order to address high unmet needs.
He said the company is actively enrolling patients in a Phase 2 study evaluating its new drug candidate NRX-101 for bipolar depression in patients with sub-acute suicidal ideation and behavior. During the second half of the year, Besthof said, the company intends to start a Phase 2/3 study of the compound for severe bipolar depression.
Besthof has served as interim CEO of NRx since the retirement Dr. Jonathan Javitt, the company's founder, in March. Javitt is now serving as a consultant to the company in the role of chief scientist.