Dermatology | Phase II Developments | UNITED STATES

Kiniksa Pharmaceuticals

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Kiniksa Announces Phase 2 Clinical Trial of Vixarelimab (KPL-716) in Prurigo Nodularis Meets Primary Efficacy Endpoint

Lead Product(s): Vixarelimab

Therapeutic Area: Dermatology

Highest Development Status: Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 22, 2020

Details:

The trial met its primary efficacy endpoint: the reduction in weekly-average WI-NRS from baseline was significantly greater in patients who received vixarelimab versus those who received placebo.

Concert Pharmaceuticals

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Concert Pharmaceuticals Announces Plans for CTP-543 Phase 3 Trials in Alopecia Areata

Lead Product(s): Deuterated Ruxolitinib

Therapeutic Area: Dermatology

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 01, 2020

Details:

Concert discussed key aspects of its planned Phase 3 trials in adult patients with the U.S. Food and Drug Administration (FDA) at a recently conducted End-of-Phase 2 meeting.

Processa Pharmaceuticals

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Processa Pharmaceuticals To Move Forward With A PCS499 Phase 3 Trial After A Successful FDA Meeting

Lead Product(s): PCS499

Therapeutic Area: Dermatology

Highest Development Status: Phase II 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:

With input from the FDA, Processa will be designing and conducting a Phase 3 trial to evaluate the ability of PCS499 to completely close ulcers in patients with NL.

Asana BioSciences

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Asana BioSciences Announce ASN008 Achieves Positive Results

Lead Product(s): ASN008

Therapeutic Area: Dermatology

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 10, 2020

Details:

The results showed that a single application of ASN008 achieved a clinically meaningful reduction in pruritus of ? 4 points on the NRS in 2-3 hours.

Emerald Health Pharmaceuticals

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Emerald Health Pharmaceuticals Receives Fast Track Designation from US FDA for EHP-101 in the Treatment of Systemic Sclerosis

Lead Product(s): EHP-101

Therapeutic Area: Dermatology

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 03, 2020

Details:

EHP is currently initiating a Phase 2 clinical study for systemic sclerosis in Australia, New Zealand and the United States with EHP-101.

Concert Pharmaceuticals

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Concert Pharmaceuticals Selected for Late-Breaking Oral Presentation of CTP-543 Phase 2 Data in Alopecia Areata

Lead Product(s): Deuterated Ruxolitinib

Therapeutic Area: Dermatology

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 24, 2020

Details:

Oral JAK1/JAK2 Inhibitor CTP-543 achieves primary endpoint in patients with Alopecia Areata.

Brickell Biotech

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Brickell Biotech Announces Publication of its U.S. Phase 2b Study Results for Sofpironium Bromide

Lead Product(s): Sofpironium Bromide

Therapeutic Area: Dermatology

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 20, 2020

Details:

In this Phase 2b dose-finding study, sofpironium bromide elicited clinically and statistically significant sustained reductions in sweating severity and was well tolerated.

Bodor Laboratories

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Brickell Biotech Announces Settlement of Dispute with Bodor Labs

Lead Product(s): Sofpironium Bromide

Therapeutic Area: Dermatology

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Brickell Biotech

Deal Size: $3.5 million Upfront Cash: $1.0 million

Deal Type: Licensing Agreement February 18, 2020

Details:

The settlement resolves the previously disclosed dispute related to the sofpironium bromide license agreement allowing the Company to continue to produce sofpironium bromide to treat hyperhidrosis.