Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) shares made a solid gain on Monday after the firm announced results from a midstage trial. Specifically, tradipitant met the primary endpoint in VLY686-2301, a Phase 2 clinical study in patients with idiopathic and diabetic gastroparesis.
Overall the study showed that tradipitant was well tolerated with comparable rates of adverse events between the tradipitant and placebo groups.
Tradipitant met the primary endpoint of the study of change in nausea score as measured by patient daily diaries and also met the related endpoint of improvement in the number of nausea-free days. Tradipitant also showed significant improvement in most of the secondary endpoints studied, including the several key scales reflecting overall gastroparesis symptoms.
Improvements also were 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.
Mihael H. Polymeropoulos M.D., Vanda’s president and CEO, commented:
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.
Shares of Vanda traded up nearly 16% early Monday at $29.02, with a consensus analyst price target of $28.50 and a new 52-week range of $13.30 to $29.20.
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