Vanda Pharmaceuticals has partnered with The Feinstein Institutes for Medical Research’s arm Northwell Health to conduct a Phase III clinical trial of tradipitant to treat severe Covid-19 pneumonia.
Enrolment for the trial, called ODYSSEY, has begun. The first patient was enrolled on 15 March at Lenox Hill Hospital, New York City, US.
Tradipitant is a neurokinin-1 receptor (NK-1R) antagonist licensed by the company from Eli Lilly. The drug is being developed to treat gastroparesis, motion sickness, and atopic dermatitis.
The double-blind, placebo-controlled, randomised ODYSSEY trial will assess the safety and efficacy of oral, 85mg twice-daily dose of the drug in treating neurogenic inflammation of the lung caused by Covid-19.
SARS-CoV-2, the novel coronavirus that causes Covid-19, is responsible for inflammation of the lower respiratory tract, which may progress to acute respiratory distress syndrome (ARDS) requiring mechanical ventilation.
The Phase III trial is designed to recruit around 300 participants with confirmed Covid-19 pneumonia. Patients will be given tradipitant or placebo.
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Clinical and laboratory outcomes will be monitored to establish the tradipitant’s efficacy in treating pneumonia associated with the novel coronavirus infection.
Vanda Pharmaceuticals president and CEO Mihael Polymeropoulos said: “With the strong leadership and health expertise of Northwell Health, we expect to be able to accelerate enrollment in this study and provide results in the coming months.
“As the mortality rate from Covid-19 continues to rise in New York from ARDS, it is critical for clinical research to be fully embraced by the public, scientific community, health professionals and the government.”
The primary outcome of the Phase III trial is the proportion of patients with normalisation of fever and oxygen saturation by day 14.
Secondary outcome measures include inflammatory lung injury, viral load, and in-hospital mortality, among others.
The study is expected to be completed in August this year.