CSBio CSBio

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Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lutris Pharma Receives FDA Orphan Drug Designation for LUT014 for the Treatment of EGFRI-Induced Acneiform Rash","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase II","country":"ISRAEL","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Lutris Pharma"}]

Find Dermatology Drugs in Phase II Clinical Development in UNITED STATES

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            ABT-981 (lutikizumab) is a dual-variable-domain interleukin (IL) 1α/1β antagonist. It is under phase 2 clinical development for the treatment of adults with moderate to severe hidradenitis suppurativa.

            Lead Product(s): Lutikizumab

            Therapeutic Area: Dermatology Product Name: ABT-981

            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 January 08, 2024

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            Rinvoq (upadacitinib), a Janus kinase (JAK) inhibitor that interferes with the JAK-STAT signaling pathway, being developed for the treatment in adults with non-segmental vitiligo.

            Lead Product(s): Upadacitinib

            Therapeutic Area: Dermatology Product Name: Rinvoq

            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 October 12, 2023

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            SAR445229 (amlitelimab) is a fully human non-depleting monoclonal antibody that binds to OX40-Ligand, potential to be a first-in-class treatment for a range of immune-mediated diseases and inflammatory disorders, including moderate-to-severe atopic dermatitis and asthma.

            Lead Product(s): Amlitelimab

            Therapeutic Area: Dermatology Product Name: SAR445229

            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 June 27, 2023

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            In study, amlitelimab showed improvements in symptoms of moderate-to-severe atopic dermatitis with well-tolerated safety profile in adults whose disease can not be controlled with topical medications or for whom topical medications are not a recommended treatment approach.

            Lead Product(s): Amlitelimab

            Therapeutic Area: Dermatology Product Name: SAR445229

            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 September 30, 2021

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            As part of the agreement, HTL will validate and operate botulinum manufacturing facility in US. Botulinum is the active ingredient in Eirion's lead product candidate ET-01, a topical neuromodulator being developed for Crow's Feet wrinkles and primary axillary hyperhidrosis.

            Lead Product(s): Botulinum toxin type A

            Therapeutic Area: Dermatology Product Name: ET-01

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Eirion Therapeutics

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement September 08, 2021

            Details:

            Sanofi gains Kymab's KY1005 (Amlitelimab) to its pipeline, a fully human monoclonal antibody targeting key immune system regulator OX40L. Kymab’s pipeline also includes the oncology asset KY1044.

            Lead Product(s): Amlitelimab

            Therapeutic Area: Dermatology Product Name: KY1005

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Sanofi

            Deal Size: $1,450.0 million Upfront Cash: $1,100.0 million

            Deal Type: Acquisition April 09, 2021

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            The transaction will result in Sanofi having full global rights to KY1005, a fully human monoclonal antibody that has a novel mechanism of action. KY1005 binds to OX40-Ligand and has the potential to treat a varieties of immune-mediated diseases and inflammatory disorders.

            Lead Product(s): Amlitelimab

            Therapeutic Area: Dermatology Product Name: KY1005

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Sanofi

            Deal Size: $1,450.0 million Upfront Cash: $1,100.0 million

            Deal Type: Acquisition January 11, 2021

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            A clinically meaningful improvement in disease activity was found compared to placebo, as measured by percentage of change from baseline in the Eczema Area and Severity Index (EASI) in patients inadequately controlled by topical corticosteroids from baseline to week 16.

            Lead Product(s): KY1005

            Therapeutic Area: Dermatology Product Name: KY1005

            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 August 11, 2020

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            LUT014 is a novel B-Raf inhibitor, small molecule drug which is applied topically on the skin. It is being evaluated for the treatment of EGFRI-Induced Acneiform Rash.

            Lead Product(s): LUT-014

            Therapeutic Area: Dermatology Product Name: LUT014

            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 28, 2024

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            M1095 (sonelokimab) is an investigational ~40 kDa humanized Nanobody® consisting of three VHH domains covalently linked by flexible glycine-serine spacers. It is being evaluated for the treatment of hidradenitis suppurativa.

            Lead Product(s): Sonelokimab

            Therapeutic Area: Dermatology Product Name: M1095

            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 February 26, 2024

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