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Find Gastroenterology Drugs in Phase III Clinical Development in UNITED STATES

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            Lead Product(s): Fluticasone Propionate

            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): Risankizumab

            Therapeutic Area: Gastroenterology Product Name: Skyrizi

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Pennsylvania University

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 07, 2021

            Details:

            A significantly greater proportion of patients with Crohn's disease treated with either dose of risankizumab achieved both primary endpoints, demonstrating statistically significant results for clinical remission and endoscopic response at week 12 compared to placebo.

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            Lead Product(s): Upadacitinib

            Therapeutic Area: Gastroenterology Product Name: Rinvoq

            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 December 09, 2020

            Details:

            Significantly more upadacitinib-treated (45 mg) patients achieved clinical remission (primary endpoint per Adapted Mayo Score) at week 8 compared to placebo in adults with moderate to severe ulcerative colitis.

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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 December 08, 2020

            Details:

            The Phase 3 ELEVATE UC 52 trial is evaluating safety and efficacy of once-daily etrasimod, a highly selective, once-daily, oral sphingosine 1-phosphate (S1P) receptor modulator, in participants with moderately-to-severely active ulcerative colitis.

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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 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 Propionate

            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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            Lead Product(s): Mirikizumab

            Therapeutic Area: Gastroenterology Product Name: LY3074828

            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 12, 2020

            Details:

            Results from the 52-week study showed continued symptom improvement and reduction of intestinal mucosal inflammation in patients with moderately to severely active Crohn's disease after treatment with mirikizumab.