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Pfizer's Eczema Candidate Meets All Goals in Study on Teens
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Pfizer Inc. (PFE - Free Report) announced that its investigational oral JAK1 inhibitor, abrocitinib, met all co-primary endpoints in the fourth phase III study — JADE TEEN — from the JADE global development program. The study evaluated the candidate as a treatment for moderate-to-severe atopic dermatitis (“AD”), also known as eczema, in patients aged 12 years and above, who were also on background topical therapy.
The double-blind, placebo-controlled, parallel-group study evaluated the safety and efficacy of two doses of abrocitinib (100mg and 200mg once daily) 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 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 from baseline.
Data from the study showed that both doses of abrocitinib achieved co-primary efficacy endpoints at Week 12 in statistically significantly higher proportion of patients compared to placebo. The higher dose of the candidate achieved statistically significant reduction in itch by Weeks 2, 4, and 12 of treatment compared to placebo. However, the lower dose achieved statistically significant reduction at Week 2 but failed to sustain a significant difference at Week 4. No further evaluation of the 100mg dose was done for secondary endpoints. The safety profile for abrocitinib was consistent with previous studies.
Detailed data from the JADE TEEN study will be presented at a future scientific meeting and published in a medical journal. The company will also evaluate eligible patients, who have completed 12 weeks in the JADE TEEN study, in a long-term extension study — B7451015.
Pfizer has successfully completed three other pivotal studies under the JADE program — JADE COMPARE, JADE MONO-1 and JADE MONO-2. The company plans to file a regulatory application seeking approval for abrocitinib as a treatment for AD later this year.
Pfizer’s shares have lost 8.3% this year so far compared with a decline of 0.5% for the industry.
We would like to remind investors that the company’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.
Notably, many companies are developing medicines to address AD/eczema. The competition has intensified in the AD market with the entry of Sanofi (SNY - Free Report) /Regeneron Pharmaceuticals' (REGN - Free Report) Dupixent. Lilly's (LLY - Free Report) rheumatoid arthritis (“RA”) drug, Olumiant, and AbbVie's newly-approved RA drug, Rinvoq, are also being evaluated in late-stage studies for AD.
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
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Pfizer's Eczema Candidate Meets All Goals in Study on Teens
Pfizer Inc. (PFE - Free Report) announced that its investigational oral JAK1 inhibitor, abrocitinib, met all co-primary endpoints in the fourth phase III study — JADE TEEN — from the JADE global development program. The study evaluated the candidate as a treatment for moderate-to-severe atopic dermatitis (“AD”), also known as eczema, in patients aged 12 years and above, who were also on background topical therapy.
The double-blind, placebo-controlled, parallel-group study evaluated the safety and efficacy of two doses of abrocitinib (100mg and 200mg once daily) 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 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 from baseline.
Data from the study showed that both doses of abrocitinib achieved co-primary efficacy endpoints at Week 12 in statistically significantly higher proportion of patients compared to placebo. The higher dose of the candidate achieved statistically significant reduction in itch by Weeks 2, 4, and 12 of treatment compared to placebo. However, the lower dose achieved statistically significant reduction at Week 2 but failed to sustain a significant difference at Week 4. No further evaluation of the 100mg dose was done for secondary endpoints. The safety profile for abrocitinib was consistent with previous studies.
Detailed data from the JADE TEEN study will be presented at a future scientific meeting and published in a medical journal. The company will also evaluate eligible patients, who have completed 12 weeks in the JADE TEEN study, in a long-term extension study — B7451015.
Pfizer has successfully completed three other pivotal studies under the JADE program — JADE COMPARE, JADE MONO-1 and JADE MONO-2. The company plans to file a regulatory application seeking approval for abrocitinib as a treatment for AD later this year.
Pfizer’s shares have lost 8.3% this year so far compared with a decline of 0.5% for the industry.
We would like to remind investors that the company’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.
Notably, many companies are developing medicines to address AD/eczema. The competition has intensified in the AD market with the entry of Sanofi (SNY - Free Report) /Regeneron Pharmaceuticals' (REGN - Free Report) Dupixent. Lilly's (LLY - Free Report) rheumatoid arthritis (“RA”) drug, Olumiant, and AbbVie's newly-approved RA drug, Rinvoq, are also being evaluated in late-stage studies for AD.
Pfizer Inc. Price
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Zacks Rank
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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