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.

AbbVie Inc

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RINVOQ Monotherapy Results in Skin Clearance and Itch in First Phase 3 Study

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 June 18, 2020

Details:

Top-line results from a Phase 3 study evaluating RINVOQ in moderate to severe atopic dermatitis in adults and adolescents show both doses of upadacitinib (15 mg and 30 mg) monotherapy met all primary and secondary endpoints versus placebo.

Brickell Biotech

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Brickell Biotech Announces Positive Phase 3 Pivotal Study Results for Sofpironium Bromide in Japan Released by Development Partner

Lead Product(s): Sofpironium Bromide

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 15, 2020

Details:

The Phase 3 pivotal study evaluated a total of 281 Japanese subjects randomized 1:1 to apply sofpironium bromide gel, or vehicle gel (placebo). All subjects scores ≥ 3 and ≥ 50 mg/5 min gravimetric sweat production (GSP) in each axilla at baseline.

Eli Lilly

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Lilly and Dermira Present New Positive Lebrikizumab Phase 2b Clinical Data

Lead Product(s): Lebrikizumab

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 June 12, 2020

Details:

Data from this study suggests that treatment with lebrikizumab provided rapid and clinically meaningful improvements in itch, sleep and overall measures of quality of life.

Dermavant Sciences

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Dermavant Completes Patient Enrollment for Long-Term Safety Study of Tapinarof in Adult Patients with Psoriasis

Lead Product(s): Tapinarof

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 09, 2020

Details:

The long-term safety study is part of a Phase 3 program for Tapinarof, which also includes Psoaring 1 and Psoaring 2, two identical Phase 3 clinical trials to evaluate the efficacy and safety of Tapinarof in adult patients with Plaque Psoriasis.

Corbus Pharmaceuticals

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Corbus Pharmaceuticals Reports Last Subject Visit in RESOLVE-1 Phase 3 Study of Lenabasum for Treatment of Systemic Sclerosis

Lead Product(s): Lenabasum

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 May 27, 2020

Details:

The RESOLVE-1 Phase 3 trial is a multinational study evaluating the efficacy and safety of lenabasum in systemic sclerosis.

Dermavant Sciences

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Dermavant Announces Publication in JAAD of Secondary Efficacy and Patient-Reported Outcomes in Phase 2b Clinical Trial of Tapinarof Cream

Lead Product(s): Tapinarof

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 May 26, 2020

Details:

A significantly higher proportion of patients treated with tapinarof 1% QD reported very or moderately improved psoriasis symptoms and psoriasis-related pruritus compared with those receiving vehicle QD at Week 12.

CARA Therapeutics

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Another PhIII win in hand, Cara aims straight for priority review of 'breakthrough' pruritus drug

Lead Product(s): Difelikefalin

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 April 21, 2020

Details:

KORSUVA Injection was generally well-tolerated with a safety profile consistent with that seen in KALM-1 and the KORSUVA clinical program in patients with CKD-aP.

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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

AbbVie Inc

RINVOQ Monotherapy Results in Skin Clearance and Itch in First Phase 3 Study

Brickell Biotech

Brickell Biotech Announces Positive Phase 3 Pivotal Study Results for Sofpironium Bromide in Japan Released by Development Partner

Eli Lilly

Lilly and Dermira Present New Positive Lebrikizumab Phase 2b Clinical Data

Dermavant Sciences

Dermavant Completes Patient Enrollment for Long-Term Safety Study of Tapinarof in Adult Patients with Psoriasis

Corbus Pharmaceuticals

Corbus Pharmaceuticals Reports Last Subject Visit in RESOLVE-1 Phase 3 Study of Lenabasum for Treatment of Systemic Sclerosis

Dermavant Sciences

Dermavant Announces Publication in JAAD of Secondary Efficacy and Patient-Reported Outcomes in Phase 2b Clinical Trial of Tapinarof Cream

CARA Therapeutics

Another PhIII win in hand, Cara aims straight for priority review of 'breakthrough' pruritus drug