Date: 20-Apr-2020

Vanda Pharma, Northwell Health Begin Enrollment In ODYSSEY Trial To Treat COVID-19 Pneumonia

Vanda Pharmaceuticals Inc, a leading global biopharmaceutical company, and Northwell Health's research arm, The Feinstein Institutes for Medical Research, announced enrollment of the first patient in Vanda's clinical trial, ODYSSEY VLY-686-3501, in New York City.

ODYSSEY is a phase III double-blind placebo-controlled trial investigating the efficacy and safety of tradipitant, a neurokinin-1 receptor antagonist, in the treatment of neurogenic inflammation of the lung secondary to SARS-CoV-2 (COVID-19) infection. This novel coronavirus is associated with a lower respiratory tract inflammation that often progresses to Acute Respiratory Distress Syndrome (ARDS) requiring mechanical ventilation.

"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," said Mihael H. Polymeropoulos, M.D., president and chief executive officer of Vanda. "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. We could not think of a better partner to leverage all of these constituencies than Northwell Health as we strive to complete this study as soon as possible and bring potential relief to patients suffering from COVID-19."

The study, led by Dr. Bushra Mina, M.D., is expected to randomize approximately 300 patients with confirmed COVID-19 pneumonia who receive either tradipitant or placebo. Vanda, alongside investigators at Lenox Hill Hospital, will evaluate clinical and laboratory outcomes to determine the efficacy of tradipitant in treating patients with COVID-19 pneumonia.

"Our primary focus is to quickly evaluate the impact of tradipitant in the treatment of patients with neurogenic inflammation of the lung as a result of COVID-19," said Dr. Mina, Section chief of Pulmonary Medicine, Director of Pulmonary & Critical Care Fellowship at Lenox Hill Hospital, and lead ODYSSEY study investigator. "The initiation of this clinical trial represents a significant milestone in our efforts to combat this health crisis and support our ultimate goal of patient recovery."

"We are pleased to team up with Vanda," said Kevin J. Tracey, M.D., President and CEO of the Feinstein Institutes. "Carefully designed clinical trials are an essential early step to assess risk and benefit of experimental approaches for COVID-19."

Tradipitant is an NK-1R antagonist licensed by Vanda from Eli Lilly and Company. Tradipitant is currently in clinical development for gastroparesis, motion sickness as well as atopic dermatitis.