Dermatology | Phase III Developments

Pfizer Inc

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FCE Pharma

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

Lead Product(s): Abrocitinib

Therapeutic Area: Dermatology

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.

Alvotech

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ICELAND Iceland

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FCE Pharma

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Alvotech Announces Positive Top-Line Results for Two Comparative Studies for AVT02, a Proposed Biosimilar to HUMIRA® (Adalimumab)

Lead Product(s): Adalimumab

Therapeutic Area: Dermatology

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 May 12, 2020

Details:

The Phase 1 PK similarity study for AVT02 (AVT02-GL-101) has met its primary objectives. The Phase 3 confirmatory efficacy and safety study for AVT02 (AVT02-GL-301) has met its primary objective.

Lipidor AB

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SWEDEN Sweden

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FCE Pharma

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Lipidor Presents Updated Project Plan - Initiates Phase III study of AKP02 in-House

Lead Product(s): Calcipotriol,Betamethasone

Therapeutic Area: Dermatology

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 07, 2020

Details:

Company has successfully completed Phase III study of calcipotriol spray (AKP01) against mild to moderate plaque psoriasis and is planning for a licensing project.

CARA Therapeutics

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United States

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FCE Pharma

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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

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.

Sol-Gel Technologies

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ISRAEL Israel

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FCE Pharma

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Sol-Gel Technologies Announces Closing of Additional $5.0 Million Investment

Lead Product(s): Benzoyl Peroxide,Tretinoin

Therapeutic Area: Dermatology

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: M. Arkin Dermatology Ltd

Deal Size: $28.0 million Upfront Cash: Undisclosed

Deal Type: Financing April 13, 2020

Details:

The fund will be directed towards the NDA filling of company's drug candidates- Epsolay and Twyneo.

Menlo Therapeutics

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United States

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FCE Pharma

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Menlo Therapeutics Announces Results from Two Phase 3 Clinical Trials of Serlopitant

Lead Product(s): Serlopitant

Therapeutic Area: Dermatology

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 April 06, 2020

Details:

Study MTI-105 and Study MTI-106 did not meet their respective primary endpoint of demonstrating statistically significant reduction in pruritus in patients treated with serlopitant.

Incyte Corporation

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United States

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FCE Pharma

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Incyte Announces First Presentation of Phase 3 Data from the TRuE-AD Program of Ruxolitinib Cream

Lead Product(s): Ruxolitinib

Therapeutic Area: Dermatology

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 April 05, 2020

Details:

Ruxolitinib cream resulted in a rapid and robust clinical response, with significantly more patients achieving Investigator’s Global Assessment (IGA) Treatment Success.

Dermavant Sciences

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United States

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FCE Pharma

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Dermavant Completes Patient Enrollment for Two Phase 3 Clinical Trials of Tapinarof for the Treatment of Psoriasis

Lead Product(s): Tapinarof

Therapeutic Area: Dermatology

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 April 02, 2020

Details:

Psoaring 1 and Psoaring 2 are two identical phase 3 clinical trials that have enrolled a combined 1,025 patients to evaluate the safety and efficacy of tapinarof in adults with plaque psoriasis.

Can-Fite BioPharma

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ISRAEL Israel

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FCE Pharma

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Can-Fite Implements Interim Analysis for its Phase III Psoriasis Trial with Data Expected Q4 2020

Lead Product(s): Piclidenoson

Therapeutic Area: Dermatology

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 30, 2020

Details:

Interim analysis of the Phase III Comfort trial designed to evaluate the Company’s drug candidate, Piclidenoson, in the treatment of moderate-to-severe plaque psoriasis.

Otsuka Pharmaceutical

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JAPAN Japan

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FCE Pharma

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Medimetriks Announces that Otsuka Achieved Positive Top-Line Phase 3 Results for MM36

Lead Product(s): Difamilast

Therapeutic Area: Dermatology

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 27, 2020

Details:

Difamilast (OPA-15406) me primary end points in patients with atopic dermatitis, in both the adult and pediatric trials.

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Pfizer Inc

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

Alvotech

Alvotech Announces Positive Top-Line Results for Two Comparative Studies for AVT02, a Proposed Biosimilar to HUMIRA® (Adalimumab)

Lipidor AB

Lipidor Presents Updated Project Plan - Initiates Phase III study of AKP02 in-House

CARA Therapeutics

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

Sol-Gel Technologies

Sol-Gel Technologies Announces Closing of Additional $5.0 Million Investment

Menlo Therapeutics

Menlo Therapeutics Announces Results from Two Phase 3 Clinical Trials of Serlopitant

Incyte Corporation

Incyte Announces First Presentation of Phase 3 Data from the TRuE-AD Program of Ruxolitinib Cream

Dermavant Sciences

Dermavant Completes Patient Enrollment for Two Phase 3 Clinical Trials of Tapinarof for the Treatment of Psoriasis

Can-Fite BioPharma

Can-Fite Implements Interim Analysis for its Phase III Psoriasis Trial with Data Expected Q4 2020

Otsuka Pharmaceutical

Medimetriks Announces that Otsuka Achieved Positive Top-Line Phase 3 Results for MM36