Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that enrollment has closed in the ODYSSEY study comparing tradipitant and placebo in hospitalized COVID-19 pneumonia patients. 

Enrollment was closed because the study met the pre-defined futility criteria, indicating that the study was unlikely to succeed in its pre-specified primary endpoint. The study was designed to determine whether tradipitant plus standard of care is superior to placebo plus standard of care in treating hospitalized patients with COVID-19 pneumonia who required supplemental oxygen support. The primary endpoint of the study is the difference between treatment and placebo on time to 2-point improvement on a 7-point ordinal scale. Treatment duration was 14 days and evaluation for the primary endpoint was at Day 28. Additional secondary endpoints include other changes in clinical and laboratory status.

An independent data and safety monitoring board (DSMB) met to assess the planned interim analysis results. The DSMB determined that the study is unlikely to show a significant difference between treatment arms at the pre-specified primary endpoint and recommended termination of the study for futility. The DSMB also determined that there are no safety concerns that contributed to its recommendation. The ODYSSEY study was initiated in April 2020 with an enrollment goal of 324 patients of which 153 have enrolled to date.

Separately, Vanda will continue the genetics component of the study with the goal of identifying genetic susceptibility factors contributing to the incidence of severe pneumonia among patients infected with the SARS-CoV-2 virus. In pursuit of that goal, Vanda has recently reported in the Journal of Global Antimicrobial Resistance on loss of function mutations in the IFNAR2 gene associated with COVID-19 severe infection susceptibility.1

References

1. Smieszek, S.P., Polymeropoulos, V.M., Xiao, C., Polymeropoulos, C.M., Polymeropoulos, M.H. (2021). Loss-of-function mutations in IFNAR2 in COVID-19 severe infection susceptibility. Journal of Global Antimicrobial Resistance, S2213-7165(21)00156-9. Advance online publication. https://doi.org/10.1016/j.jgar.2021.06.005

About Tradipitant

Tradipitant is a neurokinin-1 receptor antagonist licensed by Vanda from Eli Lilly and Company. Tradipitant is currently in clinical development for gastroparesis, COVID-19 pneumonia, motion sickness and atopic dermatitis. The FDA has imposed a partial clinical hold on tradipitant clinical protocols of longer than 12 weeks duration.

About Vanda Pharmaceuticals Inc.

Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients.