Biopharmaceutical company Vanda Pharmaceuticals Inc (Nasdaq:VNDA) on Thursday launched the planned ODYSSEY VLY-686-3501 clinical study for the treatment and prevention of pneumonia associated with COVID-19 in hospitalized patients following the US FDA permission.
The company added that the ODYSSEY study will randomize 300 patients aged 18-90 at New York area hospitals and will enroll hospitalized patients with COVID-19 ARDS (Acute Respiratory Distress Syndrome) requiring mechanical ventilation.
This Phase III double-blind placebo-controlled ODYSSEY trial will investigate the efficacy and safety of the company's tradipitant given orally twice daily to treat inflammatory lung injury associated with severe COVID-19 infection.
According to the company, 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. The 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.
Upon success of the ODYSSEY study of tradipitant's effectiveness in treating COVID-19 patients with ARDS, the company will work with the US FDA in an effort to ensure that this therapy is made available to patients in an expedited manner.
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