Vanda Pharmaceuticals announced tradipitant met the primary endpoint in VLY686-2301, a Phase II clinical study in patients with idiopathic and diabetic gastroparesis. The study also showed that tradipitant was well tolerated with comparable rates of adverse events between the tradipitant and placebo groups.

"The results of the VLY686-2301 study pave the way for further development of tradipitant as potentially the first new drug for gastroparesis in almost 40 years. The highly clinically meaningful and significant improvements observed in the primary endpoint of nausea, the significant increase in nausea free days, and the reported overall symptom improvement, suggest a potential breakthrough discovery in the treatment of the millions of people estimated to have gastroparesis" said Mihael H. Polymeropoulos MD, Vanda's President and Chief Executive Officer.

VLY-686-2301 was a Phase II clinical trial that studied the effects of tradipitant (85 mg twice a day) versus placebo in 141 patients in an Intent To Treat (ITT) population with gastroparesis over a period of 4 weeks. Several symptom severity scales were used to assess gastroparesis symptoms, including the Gastroparesis Symptom Index (GCSI), Patients Assessment of Upper Gastrointestinal Disorders–Symptoms (PAGI-SYM), and Patient Global Impression of Change (PGI-C) as well as a Clinician Global Impression of Severity (CGI-S).

Tradipitant met the primary endpoint of the study of change in nausea score as measured by patient daily diaries (change of -1.2 for tradipitant versus -0.7 for placebo, p=0.0099) and also met the related endpoint of improvement in the number of nausea free days (an addition of 28.8% of days for tradipitant versus 15.0% for placebo, p=0.0160). Tradipitant also showed significant improvement in most of the secondary endpoints studied, including the several key scales reflecting overall gastroparesis symptoms; GCSI (p=0.0223); PAGI-SYM (p=0.0497); CGI-S (p=0.0207); PGI-C (p=0.0429).

In a subgroup analysis of patients that experienced both nausea and vomiting at baseline (n=101), tradipitant showed highly significant effects on the primary endpoint of change in nausea score (change of -1.4 for tradipitant versus -0.4 for placebo, p=0.00002) as well as the number of nausea free days (an addition of 32.3% for tradipitant versus 7.6% for placebo, p=0.0003).

Importantly, improvements were also seen in most of the core gastroparesis symptoms including nausea, vomiting, bloating, and fullness after meals consistent with an overall improvement and no associated worsening of any of the core symptoms. Most effects were apparent by the second week of treatment although improvements continued through the fourth and last week of treatment in the tradipitant group. Adverse events were similar in the tradipitant and placebo arms which confirms prior studies' findings that tradipitant is well tolerated.

Vanda believes that if these robust efficacy results with a well-tolerated chronic treatment safety profile are further confirmed in future studies, tradipitant has the potential to become a first line pharmacological option in the treatment of patients with gastroparesis. The detailed results of this study are expected to be presented in upcoming meetings and peer reviewed publications.

In addition, Vanda expects to meet with regulatory authorities in the near future to further define and confirm the path towards registration of tradipitant in the treatment of patients with gastroparesis.

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