The FDA has cleared an IND for NeuroRx to conduct a clinical trial of an inhaled formulation of its RLF-100 aviptadil in patients with moderate or severe COVID-19, the company said. NeuroRx recently announced that an intravenous formulation of RLF-100 has shown promising results in patients with severe COVID-19 and that researchers in Brazil have demonstrated that aviptadil can prevent replication of the SARS-CoV-2 virus in human lung cells.
NeuroRx is developing aviptadil for COVID-19 in partnership with Relief Therapeutics, which is also developing RLF-100 for the treatment of pulmonary sarcoidosis and pulmonary hypertension. RLF-100, a synthetic human vasoactive intestinal polypeptide (VIP), has been designated as a Material Threat Medical Countermeasure and has also received Fast Track designation.
According to the companies, the trial will begin around September 1 in hospitalized COVID-19 patients who have severe disease that has not yet progressed to respiratory failure. Depending on the results of that portion of the study, the trial would be expanded to include mild and moderate COVID-19 patients outside of the hospital setting.
NeuroRx CEO Jonathan Javitt commented, “Now that we know VIP suppresses replication of the SARS-CoV-2 virus in human lung cells, based on the outstanding work of the Oswaldo Cruz Institute (Rio de Janeiro). We are optimistic that treatment with VIP will not only help patients on ventilators, but will help to stop the advancement of the virus in patients with earlier stages of COVID-19. By blocking cytokine synthesis in the lung cells and increasing the production of surfactant, which is key to the lung’s ability to transmit oxygen, we are hopeful that inhaled VIP will prove to be of clinical benefit across a wider array of patients suffering respiratory complications from COVID-19 infection.”
Read the NeuroRx press release.
