Drug Enters FDA Trial at NYU Langone to Treat COVID-19-Induced ARDS

  • Coronavirus (COVID-19) death is primarily caused by Acute Respiratory Distress Syndrome (ARDS), in which severe inflammation causes the lungs to fill with fluid and even mechanical ventilation is unable to maintain life. The syndrome is caused, in part, by a Cytokine Storm unleashed by viral particles
  • VIP is known to have potent anti-cytokine effects in numerous animal models and in phase 1 and phase 2 human studies

RELIEF THERAPEUTICS Holding AG “Relief” announces that New York University Langone (NYU Langone Health) is participating in the Phase 2 clinical study of its drug Aviptadil for the treatment of Acute Respiratory Distress Syndrome (ARDS) in COVID-19. The multicenter trial will enroll patients who are already on mechanical ventilation in the hopes that Aviptadil can decrease mortality in this condition and help to improve the ability of the patient’s lungs to transfer oxygen to the body.

The trial is being led by Relief’s US partner, NeuroRx, Inc., whose clinical operations are based in Radnor, PA, under FDA Investigational New Drug clearance, as part of the FDA’s Coronavirus Treatment Acceleration Program (CTAP). Details of the study are posted on clinicaltrials.gov NCT04311697.

Death in COVID-19-infected patients is caused in part 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, even in the setting of mechanical ventilation. Emerging data from clinical centers in the North East of the USA points to mortality of 80%-90% in patients currently receiving mechanical ventilation. VIP is a naturally synthesized peptide which is 40% concentrated in the lungs and which has been shown to have a potent anti-cytokine activity in numerous animal models of respiratory distress, acute lung injury, and inflammation. It has a 20-year history of safe 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 and EU orphan drug designations for the use of VIP to treat ARDS, pulmonary hypertension, and sarcoidosis. Relief also holds a US patent1 for Aviptadil and proprietary manufacturing processes for its synthesis.

“In a previous trial of VIP for ARDS in patients with sepsis, 7 of 8 patients on mechanical ventilation showed substantial improvement and 6 ultimately left the hospital alive,” said Prof. Jonathan Javitt, MD, MPH, the CEO of NeuroRx, Inc. “Patients on ventilators for COVID-19 have less than a 50% chance of survival. 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.”

1 US 8,178,489 Formulation for Aviptadil

Source: Relief Therapeutics


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