Pfizer Sees Positive Top-Line Results for Atopic Dermatitis Drug
September 27 2019 - 7:26AM
Dow Jones News
By Chris Wack
Pfizer Inc. (PFE) said Friday it saw positive top-line results
from a second Phase 3 pivotal study evaluating the efficacy and
safety of its investigational oral Janus kinase 1, or JAK1,
inhibitor, abrocitinib, in patients aged 12 and older with moderate
to severe atopic dermatitis.
The pharmaceutical company said this is the second monotherapy
trial in the JAK1 Atopic Dermatitis Efficacy and Safety global
development program.
Pfizer first showed positive top-line results from the first
trial on May 15, and consistent with JADE MONO-1, results showed
that by week 12 the percentage of patients achieving each
co-primary efficacy endpoint and each key secondary endpoint with
either dose of abrocitinib was statistically significantly higher
than placebo. The company also said a statistically significant
number of patients achieved a reduction in pruritus by week
two.
Pfizer said the co-primary study endpoints in the study were the
proportion of patients who achieved an Investigator Global
Assessment score of clear or almost clear skin and two-point or
greater improvement; and the proportion of patients who achieved at
least a 75% or greater change from baseline in their Eczema Area
and Severity Index score.
Safety results showed that both doses of abrocitinib were
well-tolerated and were broadly consistent with the first Phase 3
study.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
September 27, 2019 07:11 ET (11:11 GMT)
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