Tradipitant Clinical Development

Phase 2
Results Demonstrate Tradipitant Improved Symptoms of Gastroparesis

VP-VLY-686-2301: Phase II study to assess the efficacy of tradipitant in relieving symptoms of gastroparesis.

Subjects: Adults with Diabetic or Idiopathic Gastroparesis
Demonstrated elayed gastric emptying
Severe to moderate nausea
Screening: 4 weeks, 2 visits
Daily Symptom Diary
Questionnaires rating overall gastroparesis
Randomization: Patients with moderate-severe nausea 50% of screening days.
NK-1R Antagonist Tradipitant 85mg BID N=77
Placebo BID N=75
Treatment: 4 weeks, 2 visits
Daily Symptom Diary
Questionnaires rating overall gastroparesis

Average Daily Diary Nausea Score
Scale: 0 (mild) to 5 (very severe)

Increased percentage of Nausea-Free Days
28.8% for tradipitant vs. 15% placebo, p=0.016
Larger improvement in total GCSI Score
-0.96 for tradipitant vs. 0.58 placebo, p=0.022
Higher rate of nausea responders
32.9% for tradipitant vs. 11.8% placebo, p=0.013

VP-VLY-686-3301: Phase III study to assess the efficacy of tradipitant in relieving symptoms of gastroparesis