Vanda Pharmaceuticals Inc. (Vanda)
VNDA today announced top-line results of the Phase II proof of
concept clinical study investigating the safety and efficacy of tradipitant as
a monotherapy in the treatment of chronic pruritus in patients with atopic
dermatitis. Despite a highly significant and clinically meaningful improvement
from baseline by tradipitant (40.5mm improvement from baseline, p<0.0001) as
measured on a 100mm unit Visual Analog Scale (VAS) for itch, a very high
placebo effect (36.5 mm improvement from baseline, p<0.0001) on the change
from baseline led to no statistical difference from placebo. However,
subsequent analysis 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.
"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," said Dr. Sonja Staender, Department of
Dermatology, and Head of the Interdisciplinary Competence Center Chronic
Pruritus (KCP) of the University Hospital in Munster, Germany.
Tradipitant, formerly known as VLY-686, is a neurokinin 1 receptor antagonist
under clinical investigation 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, however,
Vanda believes this proof of concept study was informative, in that through
subsequent analyses, it has discovered an exposure response relationship and
further observed a significant and clinically meaningful response across
several pruritus related outcomes evaluated in individuals with higher blood
plasma levels of tradipitant. This is not unexpected given that all the
assessments related to pruritus are significantly associated with the itch
sensation the patient is experiencing at that time. Based on the data Vanda
examined across the study, lower blood plasma levels of tradipitant may be
below a threshold of efficacy to ameliorate the itch sensation in patients.
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