Type: Neurokinin-1 receptor (NK-1R) antagonist
Status: Vanda Pharmaceuticals said August 18 that tradipitant may accelerate clinical improvement in SARS-CoV-2 pneumonia, based on an interim analysis of data from the first 60 patients enrolled by invitation in the Phase III ODYSSEY study (NCT04326426). The interim analysis showed that a 14 day tradipitant treatment accelerated clinical improvement by day 7, sooner than placebo, and also improved median time to clinical improvement by day 28—10 days for tradipitant, vs. 28 days for placebo.
Similar percentages of patients improved between the two treatment arms, 57% for tradipitant and 50% for placebo. The mortality rate was also similar between the treatment groups with 14.2% for tradipitant and 16.6% for placebo. Results from this interim analysis will be submitted for publication in a peer reviewed journal, Vanda said.
The double-blind placebo-controlled trial, launched in April 2020, is designed to assess the efficacy and safety of tradipitant in the treatment of neurogenic inflammation of the lung secondary to SARS-CoV-2 infection. The study is expected to enroll 300 patients; 60 patients had enrolled and completed the study as of July 15.
Vanda is developing tradipitant through a license from Eli Lilly. Tradipitant is also clinical development for gastroparesis, motion sickness and atopic dermatitis. The FDA has imposed a partial clinical hold on tradipitant clinical protocols of longer than 12 weeks’ duration.
In April, Vanda launched a research partnership with University of Illinois at Chicago (UIC) focused on the investigation of small molecules with the potential to treat COVID-19. In addition to studying cathepsin-L enzyme inhibition, Vanda said, the partners will also explore drugs that may block SARS-CoV-2 virus entry at the angiotensin converting enzyme 2 receptor, and the transmembrane protease serine 2 precursor.
The partners plan to launch in New York a clinical trial called ODYSSEY, a study of tradipitant in hospitalized patients with severe COVID-19 pneumonia that was announced on April 2.
COVID-19: 200 Candidates and Counting
To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: