NeuroRx Concludes Enrollment In Phase 2b/3 Trial For Critical COVID-19 With Respiratory Failure

(RTTNews) - NeuroRx Inc. and Relief Therapeutics Holding AG (RLFTF) announced the conclusion of enrollment in the phase 2b/3 trial of ZYESAMI, previously known as RLF-100, for the treatment of respiratory failure in patients with critical COVID-19.

NeuroRx said that no drug-related serious adverse events have been reported as of today. Enrollment was increased from 165 patients in order to amass as large a safety database as possible. It expects top line data in late January - early February 2021.

NeuroRx said that the FDA did not agree to grant emergency use authorization, as applied for in September, based upon the open-label study reported earlier. But the FDA has advised the company that they remain committed to working with the company in the development of its product and will promptly review the forthcoming data from this randomized trial.