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.