Vanda Pharmaceuticals Inc. VNDA was down 3.2% after the company announced disappointing top-line data from the phase II proof-of-concept study evaluating the safety and efficacy of its candidate, tradipitant, as a monotherapy in the treatment of chronic pruritus in patients suffering from atopic dermatitis. Overall, the stock price fell 5.3% on the news.
Although tradipitant demonstrated highly significant (40.5 mm improvement from baseline) and clinically meaningful change from baseline as measured by the Visual Analog Scale (VAS) for itch, the candidate failed to show a statistical difference from placebo. This was attributed to the very high placebo effect (36.5 mm improvement from baseline).
However, in subsequent analysis of population pharmacokinetic samples across all patients in the study, significant and clinically meaningful responses were observed across multiple outcomes evaluated in individuals with higher levels of tradipitant exposure at the time of their pruritus assessments.
We note that Vanda had licensed tradipitant from Eli Lilly and Co. LLY in 2012.
Our Take
We are disappointed with tradipitant failing to show significant difference from placebo in a mid-stage study. Meanwhile, we believe that investor focus will remain on the ramp up of the company’s sleep disorder drug, Hetlioz. Hetlioz was launched in the U.S. in April last year for the treatment of non-24-hour sleep-wake disorder. The marketing application for Hetlioz in the EU is currently under regulatory review. A decision from the European Commission is expected in the third quarter of 2015.
Some well-ranked stocks in the health care sector include Cytokinetics, Inc CYTK and Alnylam Pharmaceuticals, Inc. ALNY. While Cytokinetics carries a Zacks Rank #1 (Strong Buy), Alnylam is a Zacks Rank #2 stock.
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