Gastroenterology | Phase III Developments

Takeda Pharmaceutical

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JAPAN Japan

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Takeda: Subcutaneous Formulation Of Vedolizumab Receives Positive CHMP Opinion

Lead Product(s): Vedolizumab

Therapeutic Area: Gastroenterology

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 February 28, 2020

Details:

If approved, vedolizumab will become the only maintenance therapy for ulcerative colitis or Crohn's disease with both intravenous and subcutaneous formulations across the European Union.

Ironwood Pharmaceuticals

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United States

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Ironwood Pharmaceuticals Announces Publication of Positive IW-3718 Phase IIb Data in Gastroenterology

Lead Product(s): Colesevelam Hydrochloride

Therapeutic Area: Gastroenterology

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 February 26, 2020

Details:

Data showed improvement in both heartburn and regurgitation symptoms and further demonstrated the role of bile acid in refractory gastroesophageal reflux disease (GERD

Galera Therapeutics

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Galera Therapeutics Announces Presentation of Avasopasem Manganese (GC4419) Two-Year Tumor Outcomes Data

Lead Product(s): Avasopasem manganese

Therapeutic Area: Gastroenterology

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 February 24, 2020

Details:

Galera will present data from the two-year tumor outcomes follow up of patients with head and neck cancer treated with lead product GC4419, for severe oral mucositis in a Phase 2b clinical trial.

Janssen Pharmaceutical

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New Interim Data from STARDUST Study Show 2/3rd of Patients Achieved Clinical Remission After Two Doses of STELARA

Lead Product(s): Ustekinumab

Therapeutic Area: Gastroenterology

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 February 14, 2020

Details:

First study to explore a treat-to-target strategy in crohn’s disease using endoscopy to guide dose adjustment. First study to evaluate intestinal ultrasound monitoring in an interventional setting.

Sihuan Pharmaceutical

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CHINA China

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Sihuan Pharmaceutical Accelerates Product Expansion in Digestive System and Liver Related Diseases

Lead Product(s): Anaprazole sodium

Therapeutic Area: Gastroenterology

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 February 14, 2020

Details:

The results of the completed phase II clinical trial showed that Anaprazole is effective in treating duodenal ulcer, conducive to ulcer healing and relieves ulcer-related symptoms.

Takeda Pharmaceutical

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JAPAN Japan

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Investigational Subcutaneous Formulation of Vedolizumab Achieves Clinical Remission at Week 52 in Active Crohn’s Disease

Lead Product(s): Vedolizumab

Therapeutic Area: Gastroenterology

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 February 14, 2020

Details:

At week 52, significantly more patients on vedolizumab SC compared to placebo were in clinical remission meeting the study’s primary endpoint.

Celltrion

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Korea, Republic Of

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Celltrion Reveals 1-year Data for Novel Subcutaneous Formulation of Infliximab in Crohn’s disease and Ulcerative colitis

Lead Product(s): Infliximab

Therapeutic Area: Gastroenterology

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 February 14, 2020

Details:

The results from a randomised controlled trial showed that the subcutaneous formulation of infliximab was comparable to the intravenous formulation of CT-P13 in terms of efficacy and safety.

Allena Pharmaceuticals

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Allena Pharmaceuticals Announces Streamlined Design for URIROX-2

Lead Product(s): Reloxaliase

Therapeutic Area: Gastroenterology

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 February 12, 2020

Details:

Allena now plans to reducing target enrollment to 200 subjects. Conducting earlier interim analysis, expected in Q3 2021.

Soligenix

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United States

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Soligenix Gains Japanese Dusquetide Patent Allowance in Oral Mucositis

Lead Product(s): Dusquetide

Therapeutic Area: Gastroenterology

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 February 03, 2020

Details:

The new claims cover therapeutic use of dusquetide (active ingredient in SGX942) and related innate defense regulator (IDR) analogs.

Evoke Pharma

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Evoke Pharma Enters Commercialization Agreement with EVERSANA Life Sciences for Gimoti™

Lead Product(s): Metoclopramide

Therapeutic Area: Gastroenterology

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Eversana

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement January 23, 2020

Details:

Under the terms of the agreement, Evoke retains Gimoti NDA rights as well as all legal, regulatory and production obligations, while EVERSANA will sell and supply Gimoti in the United States.

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Companies

Takeda Pharmaceutical

Takeda: Subcutaneous Formulation Of Vedolizumab Receives Positive CHMP Opinion

Ironwood Pharmaceuticals

Ironwood Pharmaceuticals Announces Publication of Positive IW-3718 Phase IIb Data in Gastroenterology

Galera Therapeutics

Galera Therapeutics Announces Presentation of Avasopasem Manganese (GC4419) Two-Year Tumor Outcomes Data

Janssen Pharmaceutical

New Interim Data from STARDUST Study Show 2/3rd of Patients Achieved Clinical Remission After Two Doses of STELARA

Sihuan Pharmaceutical

Sihuan Pharmaceutical Accelerates Product Expansion in Digestive System and Liver Related Diseases

Takeda Pharmaceutical

Investigational Subcutaneous Formulation of Vedolizumab Achieves Clinical Remission at Week 52 in Active Crohn’s Disease

Celltrion

Celltrion Reveals 1-year Data for Novel Subcutaneous Formulation of Infliximab in Crohn’s disease and Ulcerative colitis

Allena Pharmaceuticals

Allena Pharmaceuticals Announces Streamlined Design for URIROX-2

Soligenix

Soligenix Gains Japanese Dusquetide Patent Allowance in Oral Mucositis

Evoke Pharma

Evoke Pharma Enters Commercialization Agreement with EVERSANA Life Sciences for Gimoti™