Vanda Pharmaceuticals Provides Update on Tradipitant Development Program

WASHINGTON, Aug. 31, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today provided an update on its development program for tradipitant.

• Enrollment in Vanda's Phase III clinical study (VP-VLY-686-3303) in gastroparesis is expected to be completed in the first half of 2021
• The article "Efficacy and Safety of Tradipitant in Patients with Diabetic and Idiopathic Gastroparesis in a Randomized, Placebo-Controlled Trial" was accepted for publication in Gastroenterology1
• A new gastroparesis therapy could present a significant commercial opportunity, with an estimated 6 million people in the U.S. suffering from gastroparesis
• Interim analysis from ODYSSEY study shows tradipitant may accelerate clinical improvement in patients with COVID-19 pneumonia2
• Vanda is pursuing multiple short-term and long-term indications for tradipitant, including treatment of gastroparesis, COVID-19 pneumonia, motion sickness, and atopic dermatitis

Clinical progress of tradipitant in gastroparesis

Tradipitant is advancing in a Phase III study for the treatment of both diabetic and idiopathic gastroparesis.  This study is 30% enrolled at a target of 200 randomized patients, and is expected to complete enrollment in the first half of 2021.  The previous Phase II study showed significant improvement in nausea, the key symptom of gastroparesis, as well as significant improvement in the number of nausea-free days, in patients treated with 85 mg of tradipitant twice a day for 4 weeks.  The Phase III study is a 12-week study of similar design to the Phase II study in both target population and endpoints. 

The article "Efficacy and Safety of Tradipitant in Patients with Diabetic and Idiopathic Gastroparesis in a Randomized, Placebo-Controlled Trial" was accepted for publication in Gastroenterology.  A preprint is available online here.  The article describes the results of Vanda's Phase II double-blind trial of 152 adults with gastroparesis at 47 sites in the U.S. from November 2016 through December 2018.  Patients receiving tradipitant had a significant decrease in nausea score (reduction of 1.2) at week 4 compared with placebo (reduction of 0.7) (p=.0099), and a significant increase in of nausea-free days at week 4 (28.8% increase on tradipitant vs 15.0% on placebo; p=.0160). Patients with nausea and vomiting at baseline (n=101) had an even greater decrease in nausea when given tradipitant (reduction of 1.4) compared with those given placebo (reduction of 0.4) (p