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Find Gastroenterology Drugs in Phase III Clinical Development

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            Lead Product(s): Dupilumab

            Therapeutic Area: Gastroenterology Product Name: Dupixent

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Regeneron Pharmaceuticals

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 26, 2020

            Details:

            First Phase 3 trial in eosinophilic esophagitis (EoE) to show a biologic medicine significantly improved structural and histologic measures, while rapidly improving ability to swallow in patients 12 years and older.

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            Lead Product(s): Dupilumab

            Therapeutic Area: Gastroenterology Product Name: Dupixent

            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 September 14, 2020

            Details:

            Dupixent is the first and only biologic to show positive and clinically-meaningful Phase 3 results in patients 12 years and older with eosinophilic esophagitis (EoE).

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            Lead Product(s): Dupilumab

            Therapeutic Area: Gastroenterology Product Name: Dupixent

            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 11, 2020

            Details:

            Dupixent’s unique mechanism of action simultaneously inhibits IL-4 and IL-13. Recent evidence further supports additional clinical uses in diseases driven by type 2 inflammation including Eosinophilic Esophagitis and a subset of Chronic Obstructive Pulmonary Disease .

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            Lead Product(s): Fluticasone

            Therapeutic Area: Gastroenterology Product Name: APT-1011

            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 September 22, 2020

            Details:

            Ellodi Pharmaceuticals is dedicated to the clinical development of APT-1011, a novel therapy in Phase 3 development for the treatment of Eosinophilic Esophagitis (EoE) spun-out of Adare Pharmaceuticals (Adare).

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            Lead Product(s): Fexuprazan

            Therapeutic Area: Gastroenterology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Available

            Deal Size: Not Available Upfront Cash: Not Available

            Deal Type: Not Available November 06, 2020

            Details:

            Bridging study results, published in the SCI journal, AP&T, demostrate no racial differences exist in pharmacokinetic and pharmacodynamic properties of fexuprazan.

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            Lead Product(s): Lirentelimab

            Therapeutic Area: Gastroenterology Product Name: AK002

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Available

            Deal Size: Not Available Upfront Cash: Not Available

            Deal Type: Not Available November 02, 2020

            Details:

            The Company’s lead antibody, lirentelimab (AK002), is being evaluated in a Phase 3 study in eosinophilic gastritis (EG) and/or eosinophilic duodenitis (EoD) and a Phase 2/3 study in eosinophilic esophagitis (EoE).

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            Lead Product(s): Fluticasone

            Therapeutic Area: Gastroenterology Product Name: APT-1011

            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 October 27, 2020

            Details:

            All APT-1011 dose arms showed clinically meaningful and statistically significant achievement of histological remission with reduction of eosinophil counts in the esophageal mucosa, compared to placebo, at 12 weeks.

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            Lead Product(s): Lirentelimab

            Therapeutic Area: Gastroenterology Product Name: AK002

            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 October 26, 2020

            Details:

            Lirentelimab (AK002), targets Siglec-8, an inhibitory receptor selectively expressed on human mast cells and eosinophils. Drug has been studied in a prospective, multi-center, randomized, double-blind, placebo controlled, Phase 2 Study in patients with EG and/or EoD (ENIGMA).

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            Lead Product(s): Lirentelimab

            Therapeutic Area: Gastroenterology Product Name: AK002

            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 October 26, 2020

            Details:

            Lirentelimab (AK002), Subcutaneous formulation was safe and well tolerated and demonstrated sustained eosinophil suppression supporting once monthly dosing in patients with eosinophilic gastritis, eosinophilic duodenitis, eosinophilic esophagitis and other diseases.

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            Lead Product(s): Lirentelimab

            Therapeutic Area: Gastroenterology Product Name: AK002

            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 October 21, 2020

            Details:

            All AK002 dose arms showed clinically meaningful and statistically significant benefits compared to placebo on all prespecified primary and secondary endpoints, including gastrointestinal tissue eosinophil counts and patient-reported disease symptoms.

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