Vanda Pharmaceuticals 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.
"We greatly appreciate Vanda's efforts to develop innovative therapeutic treatments for COVID-19," said Dr. Bushra Mina, Pulmonary, and Critical Care physician at Lenox Hill Hospital, Northwell Health. "We share in their urgent and unrelenting efforts to bring immediate and effective treatments to the patients we are serving in this time of crisis."
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.
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"Given this critical and urgent unmet medical need, Vanda has immediately initiated activities aimed at a number of therapeutic approaches against COVID-19," said Mihael H. Polymeropoulos, M.D., President and Chief Executive Officer of Vanda. "Our approach will investigate therapeutics aimed at host processes that facilitate viral entry and replication, as well as therapeutics targeting the neuroinflammatory process that results in ARDS."
Tradipitant is currently in clinical trials for the treatment of a variety of indications, including atopic dermatitis, gastroparesis and motion sickness. In the ODYSSEY study, tradipitant will be administered in addition to the standard of care, at dosing levels previously tested and generally shown to be well tolerated.
Tradipitant targets the neurokinin-1 receptor, which is coded by the TACR1 gene and is the main receptor for substance P, an 11 amino acid neuropeptide with a diverse set of functions. It has been shown that the substance P neurokinin-1 receptor system is involved in the neuroinflammatory processes that leads to significant lung injury following a number of insults, including viral challenges.
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.