Pfizer's JAK1 Inhibitor Meets All Goals In 2nd Phase III Study
Zacks Investment Research | Sep 29, 2019 10:46PM ET
Pfizer Inc. (NYSE:PFE) announced that its investigational oral JAK1 inhibitor abrocitinib has met all co-primary and key secondary endpoints in the second pivotal phase III study (B7451013). The candidate is being evaluated as a monotherapy for the treatment of moderate-to-severe atopic dermatitis (AD) also known as eczema in patients aged 12 years and above.
The double-blind, placebo-controlled, parallel-group study (B7451013) evaluated the safety and efficacy of abrocitinib (100mg and 200mg once daily) as a monotherapy given to patients for a period of 12 weeks. The co-primary endpoints of the study were to see the proportion of patients who achieved clear or almost clear skin improvement and those who secured at least 75% or a greater level of change in their eczema area score. The key secondary endpoint was to see the proportion of patients achieving a four-point or larger reduction in itch severity or pruritus.
Top-line data from this study showed that by week 12, both doses of abrocitinib led to a statistically significantly higher percentage of patients achieving the respective co-primary efficacy endpoints and each key secondary endpoint compared to placebo. Importantly, a statistically significant number of patients attained a reduction in pruritus or itching severity by week two.
Meanwhile, both doses were well tolerated in the study.
Detailed data from this second study will be presented at a future medical meeting and also published in a medical journal.
Importantly, the safety result from this study (B7451013) was consistent and similar to the Original post
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