Vanda Pharmaceuticals has reported positive data from an interim analysis of Phase III ODYSSEY clinical trial of tradipitant in hospitalised patients with Covid-19 pneumonia.
Results showed that a 14-day therapy with tradipitant expedited clinical improvement by day 7, when compared to placebo.
This data is based on a preliminary analysis of the initial 60 participants in ODYSSEY, which is an ongoing double-blind placebo-controlled Phase III study launched in April.
The trial is assessing the efficacy and safety of tradipitant for treating neurogenic inflammation of the lung secondary to Covid-19. The drug is a neurokinin-1 receptor (NK-1R) antagonist.
Designed to enrol approximately 300 patients, the study recruited 60 patients as of 15 July. These 60 subjects completed the trial.
In the study, clinical status was determined on a seven point scale ranging from death, mechanical ventilation, different oxygen requirement levels, to hospital discharge.
Clinical improvement was considered as at least a two point improvement in the seven point ordinal scale.
Interim data from the initial 60 patients revealed improvement in similar percentages of patients between the two study groups – 57% in tradipitant and 50% in placebo arms.
The mortality rate was also similar with 14.2% in patients treated with the drug and 16.6% in those on placebo.
Also, the time to improvement analysis demonstrated that after sevens days of treatment, patients on tradipitant recovered earlier versus those on placebo, with statistical significance.
This benefit was observed to be generally consistent among subjects who had a varying degree of severity at baseline. At day 28 of the trial, the drug led to a numerical benefit over placebo, showing an earlier median time to recovery.
The company added that a larger sample size would be necessary to confirm the therapeutic benefit of the drug in hospitalised Covid-19 patients with pneumonia.
Vanda plans to partner with US government agencies and hospitals in the country to validate these findings.
Vanda Pharmaceuticals president and CEO Mihael Polymeropoulos said: “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.”
The company has scaled up the commercial manufacturing of tradipitant.