ZURICH (Reuters) – The U.S. Food and Drug Administration has granted NeuroRx Inc Investigational New Drug (IND) permission to test RLF-100 (aviptadil) for inhaled use in patients with moderate and severe COVID-19 to prevent progression to respiratory failure, it and partner Relief Therapeutics Holdings said on Thursday.
The clinical trial of the inhaled formulation of RLF-100 is expected to begin on or before Sept. 1, a joint statement said.
They said aviptadil is shown as the first COVID therapeutic to block replication of the SARS-CoV-2 virus in human lung cells and monocytes while also preventing synthesis of cytokines in the lung. It is a patented formulation of aviptadil (synthetic human Vasoactive Intestinal Polypeptide, VIP), which has been granted FDA fast track designation, FDA emergency use IND authorisation, and an expanded access protocol.
(Reporting by Michael Shields; editing by Thomas Seythal)