Vanda Pharma initiates ODYSSEY VLY-686-3501 trial of tradipitant in hospitalized patients with COVID-19.

Vanda Pharmaceuticals Inc. announced the initiation of clinical study, ODYSSEY VLY-686-3501, in hospitalized patients with COVID-19. The novel SARS-CoV-2 coronavirus is associated with a lower respiratory tract inflammation that often progresses to Acute Respiratory Distress Syndrome (“ARDS”) requiring mechanical ventilation.

Vanda has received FDA permission to proceed with the study for the treatment and prevention of pneumonia associated with COVID-19. ODYSSEY, which will begin enrolling patients this month, is a Phase III double-blind placebo-controlled trial to investigate the efficacy and safety of tradipitant, a neurokinin-1 receptor antagonist, given orally twice daily to treat inflammatory lung injury associated with severe COVID-19 infection.

The study will randomize approximately 300 patients aged 18-90 with severe COVID-19 infection who are suffering from pneumonia. The study will begin at New York area hospitals and will enroll hospitalized patients with COVID-19 ARDS.

A recent study in Wuhan, China found that 41.8% of 201 COVID-19 hospitalized patients developed ARDS, and, among these patients, 52.4% died, underscoring the high rate of mortality in this population.

If the ODYSSEY study demonstrates significant tradipitant effectiveness in treating COVID-19 patients with ARDS, Vanda will work with the FDA in an effort to ensure that this therapy is made available to patients in an expedited manner.