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: 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): Tradipitant

            Therapeutic Area: Gastroenterology Product Name: VLY-686

            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 August 31, 2020

            Details:

            Article describes Vanda's Phase II double-blind trial of 152 adults with gastroparesis in the U.S. Patients receiving tradipitant had a significant decrease in nausea score at week 4 compared with placebo, and a significant increase in of nausea-free days at week 4.

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            Lead Product(s): Cobitolimod

            Therapeutic Area: Gastroenterology Product Name: Kappaproct

            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 August 24, 2020

            Details:

            The CONDUCT study met the primary endpoint with 21.4% of patients in clinical remission at week 6 in the highest dose group receiving 250 mg x 2 cobitolimod, compared with 6.8% of patients in the placebo group.

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            Lead Product(s): Etrolizumab,Adalimumab

            Therapeutic Area: Gastroenterology Product Name: RG7413

            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 August 10, 2020

            Details:

            Etrolizumab met its primary endpoint of inducing remission versus placebo for people with ulcerative colitis in only two of three studies.

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            Lead Product(s): Etrasimod

            Therapeutic Area: Gastroenterology Product Name: APD334

            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 August 05, 2020

            Details:

            Etrasimod ELEVATE UC 52 Phase 3 trial in ulcerative colitis (UC) ongoing and on track; ELEVATE UC 12 Phase 3 trial expected to initiate in H2 2020; topline data for both trials expected by year end 2021.

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            Lead Product(s): Colesevelam

            Therapeutic Area: Gastroenterology Product Name: IW-3718

            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 July 21, 2020

            Details:

            The primary endpoint for the two identical trials – IW-3718-301 and IW-3718-302 – has been changed from the previous responder endpoint to a continuous endpoint.

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            Lead Product(s): Tradipitant

            Therapeutic Area: Gastroenterology Product Name: VLY-686

            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 July 13, 2020

            Details:

            The patient and treating physician requested expanded access to continue treatment beyond 12 weeks, as the treating physician had judged that tradipitant was the only treatment that effectively managed the patient's gastroparesis symptoms.

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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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