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Find Gastroenterology Drugs in Phase III Clinical Development in UNITED STATES

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            Lead Product(s): Larazotide Acetate

            Therapeutic Area: Gastroenterology Product Name: INN-202

            Highest Development Status: Phase III Product Type: Peptide

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 29, 2020

            Details:

            The trial is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of larazotide for patients with celiac disease who continue to experience gastrointestinal symptoms while following a gluten-free diet.

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            Lead Product(s): Dusquetide

            Therapeutic Area: Gastroenterology Product Name: SGX942

            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 24, 2020

            Details:

            Soligenix has completed patient enrollment in its Phase 3 DOM-INNATE ("Dusquetide treatment in Oral Mucositis – by modulating INNATE Immunity") study for SGX942 (dusquetide) in the treatment of oral mucositis (OM) in head and neck cancer (HNC) patients.

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            Lead Product(s): Vonoprazan

            Therapeutic Area: Gastroenterology 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:

            Phathom announced to resume enrollment and randomization of new patients in their PHALCON-EE and PHALCON-HP Phase 3 studies of vonoprazan that they have temporarily paused in March due to the COVID-19 pandemic.

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            Lead Product(s): Antolimab

            Therapeutic Area: Gastroenterology 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 03, 2020

            Details:

            Allakos is recruiting patients for two previously announced registrational clinical studies of AK002; 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): Ozanimod

            Therapeutic Area: Gastroenterology 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 02, 2020

            Details:

            Study met primary endpoints of clinical remission in induction at Week 10 and in maintenance at Week 52. Zeposia is the first oral sphingosine-1-phosphate (S1P) receptor modulator to demonstrate benefit in moderate to severe ulcerative colitis in a Phase 3 study.

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            Lead Product(s): Dupilumab

            Therapeutic Area: Gastroenterology 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 May 22, 2020

            Details:

            Dupixent demonstrated significant clinical and anatomic improvements, including the ability to swallow, in Part A of pivotal trial.

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            Lead Product(s): Antolimab

            Therapeutic Area: Gastroenterology 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 May 21, 2020

            Details:

            The two abstract will highlight the potential of a A Siglec-8 Antibody to reduce P-induced Inflammation by Inhibiting MRGPR-mediated Mast Cell Activation and Treatment of Severe Allergic Conjunctivitis with Antolimab.

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            Lead Product(s): Metoclopramide

            Therapeutic Area: Gastroenterology 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 20, 2020

            Details:

            USFDA has conditionally accepted the proprietary brand name, “Gimoti,” for the Evoke's nasal spray product candidate for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis as resubmitted in the 505 New Drug Application.

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            Lead Product(s): Antolimab

            Therapeutic Area: Gastroenterology 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 May 04, 2020

            Details:

            Patients treated with antolimab experienced sustained eosinophil depletion in blood and tissue. Blood eosinophil levels rapidly decreased and remained suppressed.

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            Lead Product(s): Larazotide Acetate

            Therapeutic Area: Gastroenterology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: RDD Pharma

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Merger April 30, 2020

            Details:

            Innovative to change its name to 9 Meters Biopharma. 9 Biopharma meters to focus on delivering novel approach including the first and only long-acting GLP-1 agonist receptor for Short Bowel Syndrome.

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