Pfizer, Inc. PFE announced that a pivotal late-stage study evaluating its investigational JAK1 inhibitor abrocitinib for the treatment of moderate-to-severe atopic dermatitis (AD), also called eczema, met all co-primary and secondary endpoints
The phase III study (B7451012) evaluated two doses (100mg and 200mg once daily) of abrocitinib (PF-04965842) monotherapy in patients aged 12 and above for over 12 weeks.
Pfizer’s shares have declined 5.7% this year so far compared with a decline of 2.5% for the industry.
Top-line data from the study showed that by week 12 both doses of abrocitinib led to statistically significantly higher percentage of patients achieving each co-primary efficacy endpoint and each key secondary endpoint compared to placebo. While the primary endpoints were the proportion of patients who achieved clear or almost clear skin improvement and the proportion who achieved at least a 75% or greater change in their eczema area, the key secondary endpoint measured the reduction in itch severity. The data also showed that a statistically significant number of patients responded to treatment during the first two to four weeks, following administration of the first dose. Moreover, both the doses were well tolerated in the study.
Detailed data from the study will be presented at a future medical meeting and also published in a medical journal. Abrocitinib received FDA’s Breakthrough Therapy designation last year in February.
In December last year, Pfizer received FDA approval for its Eucrisa topical ointment to treat eczema in patients two years and older.
A key new entrant in the eczema market is Sanofi SNY/Regeneron Pharmaceuticals REGN Dupixent. Others are also developing their key immunology candidate in late-stage studies for AD like AbbVie’s upadacitinib and Lilly’s LLY Olumiant. While upadacitinib is not yet approved to treat any indication, Olumiant is marketed fo rrheumatoid arthritis.
Pfizer currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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