Vanda Pharma Launches Clinical Trial and Major Genetic Study of COVID-19

Clinical Trials

Washington, D.C.-based Vanda Pharmaceuticals and Manhasset, New York-based The Feinstein Institutes for Medical Research, the research division of Northwell Health, enrolled the first patient in the ODYSSEY VLY-686-3501 clinical trial for COVID-19. It will test the use of tradipitant for neurogenic inflammation of the lung secondary to SARS-CoV-2 infection.

Tradipitant is a neurokinin-1 receptor antagonist licensed by Vanda from Eli Lilly and Company. It is presently under clinical development for gastroparesis, motion sickness and atopic dermatitis.

The trial is led by Bushra Mina and will randomize about 300 patients with confirmed COVID-19 pneumonia at Lenox Hill Hospital in New York City. Patients with confirmed COVID-19 pneumonia will receive either tradipitant or placebo. COVID-19 is linked with a lower respiratory tract inflammation that can progress to Acute Respiratory Distress Syndrome (ARDS) that may require 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, president and chief executive officer of Vanda.”

He went on to say, “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 Feinstein Institutes for Medical Research is the research unit of Northwell Health, the largest health care provider and private employer in the state of New York. It boasts 50 research labs, 2,500 clinical research studies and 5,000 researchers and staff.

Vanda, a biopharma company, also announced the initiation of the CALYPSO program to examine the role that human genetic variations play in COVID-19 infection and disease progression. It is collaborated with the University of Washington School of Medicine and its Virology Lab on a pharmacogenetics study in patients with COVID-19. It will sequence the genome of individual patients as well as the SARS-CoV-2 virus, with hopes of identifying genetic factors associated with disease progression and outcomes.

The study will collect Whole-Genome Sequencing data from more than 1,000 COVID-19 patients and perform Viral Genome Sequencing. They will then analyze host susceptibility as well as host-virus interactions. It is scheduled to start enrollment in the next couple weeks and be available to patients around the U.S.

“The study has the potential to provide new insights into virus-host interactions that could lead to more effective public health strategies and the design and development of vaccines and therapeutics,” said Sandra P. Smieszek, head of Genetics at Vanda. “With the vast amount of data we expect to collect, the team will aim to discern the factors associated with severity and other critical, clinical characteristics of the infected individuals.”

Alex Greninger, assistant professor of Laboratory Medicine and assistant director of the Virology Division at the U of W School of Medicine, said, “By leveraging our sequencing expertise and capabilities in collaboration with Vanda, we will be able to provide the necessary insight for potentially life-saving solutions for patients. We believe this collaboration will help answer critical questions and hopefully outcomes in the fight against COVID-19.”

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