Relief Therapeutics is conducting a US Food and Drug Administration (FDA)-approved Phase II clinical trial at New York University Langone (NYU Langone Health) to assess Aviptadil for Covid-19-related acute respiratory distress syndrome (ARDS).

The multi-centre study will involve patients on mechanical ventilation. It will investigate the drug’s ability to reduce mortality and improve the condition of the patient’s lungs to transfer oxygen to the body.

Led by the company’s US partner, NeuroRx, the trial is part of the FDA’s Coronavirus Treatment Acceleration Program (CTAP).

NeuroRx CEO Jonathan Javitt said: “In a previous trial of VIP for ARDS in patients with sepsis, seven of eight patients on mechanical ventilation showed substantial improvement and six ultimately left the hospital alive.

“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.”

Aviptadil (RLF-100) is a Vasoactive Intestinal Polypeptide (VIP) formulation that is available in Europe to treat erectile dysfunction. Relief Therapeutics noted that VIP is highly concentrated in the lung and blocks various inflammatory cytokines.

The drug received orphan drug designation in the US and EU to treat ARDS. Relief Therapeutics also has FDA and EU orphan drug designations for the use of VIP in pulmonary hypertension and sarcoidosis indications.

Death among Covid-19 patients is known to be partly caused by a ‘cytokine storm’ in the lungs, where the virus induces inflammatory molecules called ‘cytokines’.

Cytokines cause the air sacs of the lungs to fill with water, making the sacs impermeable to oxygen, even with mechanical ventilation.

In animal models of respiratory distress, acute lung injury and inflammation, VIP demonstrated a potent anti-cytokine activity.