Gastroenterology | Phase I Developments | UNITED STATES

Assembly Biosciences

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Pharmavenue, Spain 2020

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Preclinical Data from Assembly Biosciences’ Microbiome Program in Ulcerative Colitis Featured in DDW 2020 Virtual Meeting Portal

Lead Product(s): ABI-M201

Therapeutic Area: Gastroenterology

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 May 04, 2020

Details:

Assembly’s lead live biotherapeutic product candidate, ABI-M201, is being evaluated in a Phase 1b trial in patients with mildly to moderately active UC and ongoing treatment with mesalamine.

Innovation Pharmaceuticals

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Innovation Pharmaceuticals Plans for Phase 2 Trial of New Treatment for Ulcerative Colitis

Lead Product(s): Brilacidin

Therapeutic Area: Gastroenterology

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 March 05, 2020

Details:

The Company is presently interviewing Contract Research Organizations for site selection with the understanding that the goal is to initiate the trial this summer.

PvP Biologics

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Takeda buys PvP in $330M deal to bag a 2nd celiac drug

Lead Product(s): TAK-062

Therapeutic Area: Gastroenterology

Highest Development Status: Phase I Product Type: Large molecule

Partner/Sponsor/Collaborator: Takeda Pharmaceutical

Deal Size: $330.0 million Upfront Cash: Undisclosed

Deal Type: Acquisition February 26, 2020

Details:

The acquisition was triggered following the conclusion of a Phase 1 proof- of-mechanism study of investigational medicine TAK-062 (Kuma062) for the treatment of uncontrolled celiac disease.

Pandion Therapeutics

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Pandion Announces First Subject Dosed in a Phase 1 Clinical Trial of PT101

Lead Product(s): PT101

Therapeutic Area: Gastroenterology

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 February 24, 2020

Details:

Trial to evaluate safety and tolerability of PT101, as well as expansion of regulatory T cells.

Gossamer Bio

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Gossamer Bio Announces Data Presentations at the Congress of the European Crohn’s and Colitis Organisation

Lead Product(s): GB004

Therapeutic Area: Gastroenterology

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 February 13, 2020

Details:

The presentation showcased GB004 program at the 15th Annual Congress of the European Crohn’s and Colitis Organisation (ECCO).

Innovation Pharmaceuticals

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Innovation Pharmaceuticals Phase 1 Trial of Brilacidin for Ulcerative Colitis Meets Primary Endpoints

Lead Product(s): Brilacidin

Therapeutic Area: Gastroenterology

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 February 13, 2020

Details:

Preliminary top-line data from its Phase 1 trial (NCT03234465) studying the use of delayed-release tablets of Brilacidin showed the trial met its primary endpoints.

Emmaus Life Sciences

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Emmaus Life Sciences Reports Positive Top-Line Preliminary Results in First Patient in Diverticulosis Pilot Trial

Lead Product(s): Glutamine

Therapeutic Area: Gastroenterology

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 January 29, 2020

Details:

A marginal but decreased size in some of the diverticula compared to the baseline. Indications of Healing and Normalization of Bowel Movements Observed in the Initial Patient.

Innovation Pharmaceuticals

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Innovation Pharmaceuticals Completes Dosing in Phase 1 Trial for New Oral Ulcerative Colitis Drug

Lead Product(s): Brilacidin

Therapeutic Area: Gastroenterology

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 January 24, 2020

Details:

Brilacidin utilizing new delayed release technology for targeted delivery directly to colon.

Gossamer Bio

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gossamer bio announces data presentation at the 2020 crohn’s & colitis congress

Lead Product(s): GB004

Therapeutic Area: Gastroenterology

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 January 23, 2020

Details:

Gossamer bio is conducting a Phase 1 multiple ascending dose study of GB004 in healthy volunteers with Gut Biopsies.

Innovation Pharmaceuticals

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Innovation Pharmaceuticals Announces Dosing of First Cohort in Phase 1 Trial of Oral Brilacidin in Ulcerative Colitis Program; Topline Resul...

Lead Product(s): Brilacidin

Therapeutic Area: Gastroenterology

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 January 16, 2020

Details:

The start of this Phase 1 trial is a major milestone for the Company, a key part of its broader clinical program in Inflammatory Bowel Diseases (IBD).

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Assembly Biosciences

Preclinical Data from Assembly Biosciences’ Microbiome Program in Ulcerative Colitis Featured in DDW 2020 Virtual Meeting Portal

Innovation Pharmaceuticals

Innovation Pharmaceuticals Plans for Phase 2 Trial of New Treatment for Ulcerative Colitis

PvP Biologics

Takeda buys PvP in $330M deal to bag a 2nd celiac drug

Pandion Therapeutics

Pandion Announces First Subject Dosed in a Phase 1 Clinical Trial of PT101

Gossamer Bio

Gossamer Bio Announces Data Presentations at the Congress of the European Crohn’s and Colitis Organisation

Innovation Pharmaceuticals

Innovation Pharmaceuticals Phase 1 Trial of Brilacidin for Ulcerative Colitis Meets Primary Endpoints

Emmaus Life Sciences

Emmaus Life Sciences Reports Positive Top-Line Preliminary Results in First Patient in Diverticulosis Pilot Trial

Innovation Pharmaceuticals

Innovation Pharmaceuticals Completes Dosing in Phase 1 Trial for New Oral Ulcerative Colitis Drug

Gossamer Bio

gossamer bio announces data presentation at the 2020 crohn’s & colitis congress

Innovation Pharmaceuticals

Innovation Pharmaceuticals Announces Dosing of First Cohort in Phase 1 Trial of Oral Brilacidin in Ulcerative Colitis Program; Topline Resul...