By Michael Dabaie
NRx Pharmaceuticals said data were positive from its Zyesami expanded access protocol in Covid-19, sending shares 14% higher to $20.50 premarket.
The expanded access protocol included 240 intensive care unit patients suffering critical Covid-19 with respiratory failure who had exhausted all approved therapies. The clinical stage pharmaceutical company said that overall, patients receiving at least one dose of Zyesami in addition to intensive care were alive at 28 days.
This EAP provided an opportunity for regional hospitals to offer Zyesami to its sickest patients, for whom no other options were available, and who couldn't enroll in a study due to additional risk factors. Enrollment in the EAP was offered to patients who were ineligible for the Zyesami phase 2b/3 clinical trial, and who had exhausted all approved therapies for Covid-19.
NRx said 56% of patients enrolled were already receiving mechanical ventilation, and 44% were receiving non-invasive forms of ventilation.
The company is providing the EAP data to the Food and Drug Administration as "real world data", in support of the findings from the Zyesami randomized controlled phase 2b/3 clinical trial.
Write to Michael Dabaie at firstname.lastname@example.org
(END) Dow Jones Newswires
June 15, 2021 09:04 ET (13:04 GMT)Copyright (c) 2021 Dow Jones & Company, Inc.