Interim analysis from a phase 3 study of tradipitant (Vanda Pharmaceuticals) demonstrated that it may accelerate clinical improvement in hospitalized adults with pneumonia associated with coronavirus disease 2019 (COVID-19).
The ongoing double-blind, placebo-controlled ODYSSEY study is evaluating the efficacy and safety of tradipitant, a neurokinin-1 receptor (NK-1R) antagonist, in adults with neurogenic inflammation of the lung secondary to COVID-19 infection. The study is expected to include a total of 300 patients; as of July 15, 2020, there were 60 patients enrolled. Patients were randomized 1:1 to receive either tradipitant 85mg orally twice daily or placebo in addition to standard of care.
The primary outcome measure was time to clinical improvement defined as at least a 2-point improvement on a 7-point ordinal scale ranging from death, to mechanical ventilation, various levels of oxygen requirements, to hospital discharge.
Preliminary findings showed that following 7 days of treatment, patients in the tradipitant arm recovered earlier than those who received placebo (hazard ratio [HR] 2.55; P =.0375); this clinical benefit was consistent among patients of varying degree of severity at baseline. At day 28, the median time to clinical improvement was observed to be 10 days in the tradipitant arm and 28 days for placebo (HR 1.55; P =.2254). Both treatment arms had similar overall rates of improvement and mortality.
Results from the interim analysis will be submitted for publication in a peer reviewed journal. According to Vanda, significant supplies of tradipitant are expected to be available in the coming months. Additionally, the Company plans to investigate tradipitant for the treatment of seasonal influenza pneumonia.
“These results, albeit preliminary, are exciting, offering the promise of a significant contribution in the treatment of COVID-19 and the prospect of making tradipitant part of the standard of care in accelerating recovery for patients with COVID-19 pneumonia,” said Mihael H. Polymeropoulos, MD, President and CEO of Vanda Pharmaceuticals.
Tradipitant is also being evaluated in the treatment of gastroparesis, motion sickness and atopic dermatitis.
For more information visit vandapharm.com.
Vanda Pharmaceuticals’ interim analysis from ODYSSEY study shows tradipitant may accelerate clinical improvement in patients with COVID-19 pneumonia. https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-interim-analysis-from-odyssey-study-shows-tradipitant-may-accelerate-clinical-improvement-in-patients-with-covid-19-pneumonia-301113676.html. Accessed August 18, 2020.