FDA Grants IND for Inhaled Therapy for Patients with Moderate and Severe COVID-19

The US Food and Drug Administration (FDA) has granted NeuroRx and Relief Therapeutics an Investigational New Drug (IND) permission to test RLF-100 for inhaled use in patients with moderate and severe coronavirus 2019 (COVID-19) in order to prevent progression to respiratory failure.

The first phase will commence with patients hospitalized for severe COVID-19 who do not yet have respiratory failure. If promising results are seen in the inpatient setting, the trial will expand to patients at home with mild and moderate COVID-19 in order to prevent the need for hospital admission.

Within the last week, NeuroRx and Relief Therapeutics reported results of its antiviral Vasoactive Intestinal Polypeptide (VIP) therapy, which provided rapid respiratory failure reduction in most clinically ill patients with COVID-19—at a time when independent research also showed it blocked replication of SARS-CoV-2 in human lung cells and monocytes.

“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,” NeuroRx CEO and Chairman Jonathan Javitt, MD, MPH, said. “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."

Brazilian investigators from the Oswaldo Cruz Institute showed VIP is capable of inhibiting SARS-CoV-2 virus replication in human lung cells and monocytes. The South American team reported a case-control study showing patients who survived while on ventilators for COVID-19 had significantly greater VIP count in their blood than those who died from respiratory failure.

Although first identified in the intestinal tract, VIP is produced throughout the body and is concentrated primarily in the lungs. VIP has been shown in more than 100 peer-reviewed studies to have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation.

And, 70% of the VIP in the body is bound to a rare cell in the lung, the alveolar type 2 cell, which is critical for the transmission of oxygen to the body.

VIP has a 20-year history of safe use in humans in multiple human trials for sarcoidosis, pulmonary fibrosis, asthma/allergy, and pulmonary hypertension.

The clinical trial for the RLF-100 inhaled formulation is expected to begin on or before September 1, 2020.