Relief Therapeutics Holding and NeuroRx, Wilmington, filed an Investigational New Drug (IND) Application with the US Food and Drug Administration for a phase 2 trial of RLF-100 (Aviptadil) in the treatment of patients with coronavirus.
NeuroRx, Inc. is a privately held, drug development company. Swiss-based Relief previously partnered with Biogen to develop Aviptadil, a form of VIP, for the treatment of pulmonary hypertension.
“In a previous trial of VIP for ARDS (Acute Respiratory Distress Syndrome) caused by sepsis, seven of eight patients on mechanical ventilation showed substantial improvement and six ultimately left the hospital alive,” said Jonathan Javitt, MD the CEO of NeuroRx, Inc. and vice chairman nominee of Relief. “Patients on ventilators for COVID-19 have only a 50 percent chance of survival and if the early results can be replicated in ARDS caused by COVID-19, this treatment could have a major impact both on COVID-19 survival and on the availability of ventilators for those in desperate need. Should this trial demonstrate efficacy, Relief Therapeutics has sufficient immediately shippable drug substance to treat more than 100,000 Americans.”
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 of the lungs to fill with water and become impermeable to oxygen, even with mechanical ventilation.
VIP is a naturally synthesized peptide that is 40 percent concentrated in the lungs and has been shown to have potent anti-cytokine activity in numerous animal models of respiratory distress, acute lung injury, and inflammation.
It has a 20-year history of use in human beings in multiple human trials for sarcoidosis, pulmonary fibrosis, and pulmonary hypertension, and is marketed in Europe as a local injection to treat erectile dysfunction.
Relief Therapeutics holds FDA orphan drug designations for the use of VIP to treat ARDS, pulmonary hypertension, and sarcoidosis. Relief also holds a US patentiii for Aviptadil and proprietary manufacturing processes for its synthesis.