Pfizer Inc. 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 first phase III study (B7451012) on abrocitinib announced in May 2019. The first study too met all the co-primary and secondary endpoints.
Shares of Pfizer have lost 17.1% so far this year, wider than the industry's decrease of 0.6%.
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We would like to remind investors that Pfizer’s PDE4 inhibitor Eucrisa topical ointment is already approved in the United States and Canada to treat eczema in patients aged two years and older. In July 2019, the company announced positive top-line results from a late-stage study on Eucrisa (crisaborole ointment, 2%) for the treatment of mild-to-moderate AD in children aged from three months to two years.
Notably, many companies are developing medicines to address AD/eczema. A key new entrant in the AD market is Sanofi SNY/Regeneron Pharmaceuticals' REGN Dupixent. Lilly's LLY rheumatoid arthritis (RA) drug Olumiant and AbbVie's newly-approved RA drug upadacitinib are also being evaluated in late-stage studies for AD.
In a separate press release, Pfizer announced that Mr. Ian C. Read, executive chairman of the board, has decided to retire on Dec 31, 2019. The company has appointed its current chief executive officer Dr. Albert Bourla as the new chairman effective Jan 1, 2020.
Zacks Rank
Pfizer currently carries a Zacks Rank #4 (Sell).
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