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Find Gastroenterology Drugs in Phase I Clinical Development in UNITED STATES

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            Lead Product(s): MORF-057

            Therapeutic Area: Gastroenterology Product Name: MORF-057

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 23, 2020

            Details:

            MORF-057 is in clinical development as an oral small molecule inhibitor of the α4β7 integrin for the treatment of inflammatory bowel disease (IBD) with an initial focus on ulcerative colitis (UC).

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            Lead Product(s): CERC-002

            Therapeutic Area: Gastroenterology Product Name: AEVI-002

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 26, 2020

            Details:

            Cerecor has resumed the Phase 1b clinical study of CERC-002 in anti-TNF refractory adult Crohn’s patients with the lifting of the moratorium on elective endoscopy resulting from the COVID-19 pandemic.

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            Lead Product(s): IMU-856

            Therapeutic Area: Gastroenterology Product Name: IMU-856

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 20, 2020

            Details:

            Immunic has dosed first healthy volunteer in the company’s phase 1 clinical program of IMU-856, an orally available, small molecule modulator that targets a yet undisclosed protein which serves as a transcriptional regulator of intestinal barrier function.

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            Lead Product(s): L-Glutamine

            Therapeutic Area: Gastroenterology Product Name: Undisclosed

            Highest Development Status: Phase I 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:

            The study is utilizing the same pharmaceutical-grade L-glutamine (PGLG) oral powder used in Endari® to evaluate the change in the number and size of colonic diverticula and assess safety.

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            Lead Product(s): PT101

            Therapeutic Area: Gastroenterology Product Name: PT101

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: Undisclosed

            Deal Size: $75.0 million Upfront Cash: Undisclosed

            Deal Type: Public Offering June 29, 2020

            Details:

            Funds will be used in company's lead asset, PT101, a combination of an interleukin-2 mutein effector module with a protein backbone, designed to selectively expand regulatory T cells systemically without activating proinflammatory cells.

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            Lead Product(s): OPL-002

            Therapeutic Area: Gastroenterology Product Name: OPL-002

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 23, 2020

            Details:

            In the Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) study, OPL-002 was well tolerated in a once-daily administration to healthy subjects for up to 28 days.

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            Lead Product(s): ABI-M201

            Therapeutic Area: Gastroenterology Product Name: ABI-M201

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: AbbVie Inc

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Termination June 18, 2020

            Details:

            Assembly Biosciences will regain worldwide rights to all microbiome candidates subject to the collaboration, including ABI-M201 and ABI-M301.

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            Lead Product(s): BT051

            Therapeutic Area: Gastroenterology Product Name: Undisclosed

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 10, 2020

            Details:

            The Phase 1 clinical trial is evaluating various dose levels of BT051 for safety, tolerability and pharmacokinetics in a double-blind, placebo-controlled study in healthy volunteers.

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            Lead Product(s): VE202

            Therapeutic Area: Gastroenterology Product Name: Undisclosed

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: JSR LIFE SCIENCES CORP

            Deal Size: $71.1 million Upfront Cash: Undisclosed

            Deal Type: Series C Financing June 09, 2020

            Details:

            Proceeds from the financing will supoorts company's ongoing effort in advancing Phase 1 studies in healthy volunteers of VE202, the Company’s orally-administered live biotherapeutic product (LBP) candidate for inflammatory bowel disease (IBD).

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            Lead Product(s): PT101

            Therapeutic Area: Gastroenterology Product Name: Undisclosed

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 09, 2020

            Details:

            Patent protects foundational intellectual property and pioneering work on Pandion’s therapeutic autoimmune regulatory protein (TALON) drug design platform.

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