Dermatology | Phase III Developments | UNITED STATES

Pfizer Inc

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Pfizer Announces Positive Top-Line Results from JADE TEEN Trial of Abrocitinib in Adolescents with Moderate-to-Severe Atopic Dermatitis

Lead Product(s): Abrocitinib

Therapeutic Area: Dermatology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 10, 2020

Details:

Results showed that the percentage of patients achieving each co-primary efficacy endpoint at Week 12 was statistically significantly higher with both doses of abrocitinib than with placebo.

Pfizer Inc

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Complete Results from Second Pivotal Monotherapy Study of Abrocitinib Published in JAMA Dermatology

Lead Product(s): Abrocitinib

Therapeutic Area: Dermatology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 03, 2020

Details:

Abrocitinib met all key endpoints,demonstrating statistically superior improvements in skin clearance, disease extent and severity, and itch compared to placebo.

Pfizer Inc

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Pfizer’s Dupixent rival makes the grade in phase 3—again

Lead Product(s): Abrocitinib

Therapeutic Area: Dermatology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 18, 2020

Details:

JADE COMPARE trial met all co-primary endpoints Study included dupilumab in active control arm Safety profile for abrocitinib consistent with previous studies.

Brickell Biotech

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Brickell Biotech Announces Issuance of New Composition of Matter Patent on Sofpironium Bromide by the Japanese Patent Office

Lead Product(s): Sofpironium Bromide

Therapeutic Area: Dermatology Product Name: BBI-4000

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Kaken Pharmaceuticals

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 31, 2020

Details:

Brickell and Kaken Pharmaceutical were granted by the Japanese Patent Office a composition of matter patent with claims directed to the novel polymorphic, or crystalline, forms of sofpironium bromide, a retrometabolically designed new chemical entity.

Dermavant Sciences

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Dermavant Reports Positive Phase 3 Results for Tapinarof Cream in Adult Patients with Plaque Psoriasis

Lead Product(s): Tapinarof

Therapeutic Area: Dermatology Product Name: DMVT-505

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 26, 2020

Details:

In PSOARING 1 and PSOARING 2, tapinarof cream demonstrated highly statistically significant improvement in Physician Global Assessment (PGA) score of clear or almost clear with a minimum 2-grade improvement compared to vehicle from baseline at Week 12.

Revance Therapeutics

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Revance Announces Two Peer-Reviewed Publications Reporting Safety and Efficacy Results from the SAKURA 3 Open-Label Safety Study

Lead Product(s): Daxibotulinumtoxin A

Therapeutic Area: Dermatology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 11, 2020

Details:

The two publications reported efficacy data as well as detailed safety results from the SAKURA 3 Phase 3 open-label, long-term safety study. The SAKURA 3 study is part of the largest Phase 3 clinical development program for a neuromodulator in the treatment of glabellar lines.

Arcutis Biotherapeutics

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Journal of Drugs in Dermatology Publishes Results from Phase 1/2a Trial of Arcutis’ ARQ-151 for the Treatment of Chronic Plaque Psoriasis

Lead Product(s): Roflumilast

Therapeutic Area: Dermatology Product Name: ARQ-151

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 03, 2020

Details:

Data demonstrate potential “Best in Class” topical PDE4 inhibitor roflumilast significantly improves signs and symptoms of chronic plaque psoriasis .

AbbVie Inc

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Third Pivotal Phase 3 Study Shows RINVOQ Plus Topical Corticosteroids Improves Skin and Itch Symptoms in Atopic Dermatitis Patients

Lead Product(s): Upadacitinib

Therapeutic Area: Dermatology Product Name: Rinvoq

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 28, 2020

Details:

Positive top-line results show upadacitinib (15 mg and 30 mg) plus topical corticosteroids (TCS) met the co-primary endpoints and all secondary endpoints in adult and adolescent patients with moderate to severe atopic dermatitis versus placebo plus TCS.

AbbVie Inc

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RINVOQ™ (upadacitinib) Monotherapy Meets All Primary and Secondary Endpoints in Second Phase 3 Study for Atopic Dermatitis

Lead Product(s): Upadacitinib

Therapeutic Area: Dermatology Product Name: Rinvoq

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 21, 2020

Details:

In the Measure Up 2 study—Rinvoq's second pivotal trial in eczema—60% of patients treated with a once-daily, 15-milligram dose of AbbVie's drug saw a 75% reduction in symptoms after 16 weeks, compared with 13% of those on placebo.

Arcutis Biotherapeutics

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The New England Journal of Medicine Publishes Results from Positive Phase 2b Trial of Arcutis’ ARQ-151 for Chronic Plaque Psoriasis

Lead Product(s): Roflumilast

Therapeutic Area: Dermatology Product Name: ARQ-154

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 15, 2020

Details:

Data demonstrate potential “Best in Class” topical PDE4 inhibitor roflumilast significantly improves chronic plaque psoriasis.

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Pfizer Inc

Pfizer Announces Positive Top-Line Results from JADE TEEN Trial of Abrocitinib in Adolescents with Moderate-to-Severe Atopic Dermatitis

Pfizer Inc

Complete Results from Second Pivotal Monotherapy Study of Abrocitinib Published in JAMA Dermatology

Pfizer Inc

Pfizer’s Dupixent rival makes the grade in phase 3—again

Brickell Biotech

Brickell Biotech Announces Issuance of New Composition of Matter Patent on Sofpironium Bromide by the Japanese Patent Office

Dermavant Sciences

Dermavant Reports Positive Phase 3 Results for Tapinarof Cream in Adult Patients with Plaque Psoriasis

Revance Therapeutics

Revance Announces Two Peer-Reviewed Publications Reporting Safety and Efficacy Results from the SAKURA 3 Open-Label Safety Study

Arcutis Biotherapeutics

Journal of Drugs in Dermatology Publishes Results from Phase 1/2a Trial of Arcutis’ ARQ-151 for the Treatment of Chronic Plaque Psoriasis

AbbVie Inc

Third Pivotal Phase 3 Study Shows RINVOQ Plus Topical Corticosteroids Improves Skin and Itch Symptoms in Atopic Dermatitis Patients

AbbVie Inc

RINVOQ™ (upadacitinib) Monotherapy Meets All Primary and Secondary Endpoints in Second Phase 3 Study for Atopic Dermatitis

Arcutis Biotherapeutics

The New England Journal of Medicine Publishes Results from Positive Phase 2b Trial of Arcutis’ ARQ-151 for Chronic Plaque Psoriasis