Swiss drug development company Relief Therapeutics Holding AG (SIX:RLF) and NeuroRx, a Delaware Corporation, said on Thursday that they have jointly submitted an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for the launch of a phase 2 trial of RLF-100 (Aviptadil or VIP) in the treatment of Acute and Moderate Respiratory Distress in patients infected with the COVID-19 coronavirus.
Relief Therapeutics previously partnered with Biogen to develop Aviptadil for the treatment of pulmonary hypertension.
Death in COVID-19-infected patients is caused by a "cytokine storm" in the lungs, in which the virus triggers inflammatory molecules called "cytokines", which cause the air sacs (alveolae) of the lungs to fill with water and become impermeable to oxygen.
VIP (Vasoactive Intestinal Polypeptide) is a naturally synthesized peptide which is 40% concentrated in the lungs and has been shown to have a potent anti-cytokine activity in numerous animal models of respiratory distress, acute lung injury and inflammation. VIP has a 20-year history of safe use in human beings in multiple human trials for sarcoidosis, pulmonary fibrosis and pulmonary hypertension.
Relief Therapeutics holds FDA orphan drug designations for the use of VIP to treat Acute Respiratory Distress Syndrome (ARDS), pulmonary hypertension and sarcoidosis and holds a US patent for Aviptadil and proprietary manufacturing processes for its synthesis.
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