Pfizer Sees Positive Top-Line Results for Atopic Dermatitis Drug

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 [e-mail]

(END) Dow Jones Newswires

September 27, 2019 07:11 ET (11:11 GMT)

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