Vanda Pharmaceuticals declares Tradipitant Phase II Proof of Concept study results for Chronic Pruritus

Although the results from both placebo (36.5 mm improvement from baseline, p < 0.0001) and Tradipitant (40.5mm improvement from baseline, p < 0.0001) displayed significant and clinically meaningful improvement from baseline as measured on a 100mm unit Visual Analog Scale for itch, there was no statistical difference between treatment groups due to high placebo effect.

Meanwhile, the analyses of population PK samples across all patients in the study revealed significant and clinically meaningful responses across multiple outcomes evaluated in individuals with higher levels of Tradipitant exposure at the time of their pruritus assessments.

Commenting on the results, Dr. Sonja Staender, Department of Dermatology, and Head of the Interdisciplinary Competence Center Chronic Pruritus (KCP) of the University Hospital in Munster, Germany said: "The results of this exploratory study are encouraging and promising; a target-specific therapy using an NK-1 receptor antagonist in severe atopic dermatitis pruritus is a novel concept and will help AD patients suffering from the symptom worldwide."

Tradipitant, formerly known as VLY-686, is a neurokinin 1 receptor antagonist which is currently being studied as a potential agent for the treatment of chronic pruritus in patients with atopic dermatitis.

The pre-specified primary endpoint of the Phase II proof of concept clinical study was the change from baseline on the Visual Analog Scale (VAS) for itch. Due to high placebo effect, there was no significant difference from placebo on this pre-specified endpoint.

Vanda is of the opinion that this proof of concept study was informative, as through subsequent analyses, it was found that that there was an exposure response relationship and a significant and clinically meaningful response across several pruritus related outcomes evaluated in individuals was also discovered with higher blood plasma levels of Tradipitant.