Gastroenterology | Phase III Developments

Sanofi

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FRANCE France

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Sanofi to present growth opportunities and development strategy for Dupixent® (dupilumab) in type 2 inflammatory diseases

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 .

Phathom Pharmaceuticals

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United States

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Phathom Pharmaceuticals Provides Clinical Trial Status Update

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.

Allakos

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United States

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Allakos Initiates Patient Recruitment for AK002 Registrational Studies

Lead Product(s): Antolimab

Therapeutic Area: Gastroenterology Product Name: Undisclosed

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 03, 2020

Details:

Allakos is recruiting patients for two previously announced registrational clinical studies of AK002; a Phase 3 study in eosinophilic gastritis (EG) and/or eosinophilic duodenitis (EoD) and a Phase 2/3 study in eosinophilic esophagitis (EoE).

Bristol-Myers Squibb

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United States

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Bristol Myers Squibb Announces Topline Results from Pivotal Phase 3 True North Trial Evaluating Zeposia in Patients with Moderate to Severe ...

Lead Product(s): Ozanimod

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 02, 2020

Details:

Study met primary endpoints of clinical remission in induction at Week 10 and in maintenance at Week 52. Zeposia is the first oral sphingosine-1-phosphate (S1P) receptor modulator to demonstrate benefit in moderate to severe ulcerative colitis in a Phase 3 study.

Takeda Pharmaceutical

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JAPAN Japan

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European Commission Releases Takeda From Commitment to Divest Shire’s Pipeline Compound SHP647

Lead Product(s): Ontamalimab

Therapeutic Area: Gastroenterology Product Name: Undisclosed

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 May 28, 2020

Details:

Takeda will discontinue the current SHP647 clinical trial program, and it will be providing all eligible trial participants with the opportunity to have continued access to SHP647 in a post-trial access study.

Regeneron Pharmaceuticals

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United States

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Dupixent® (dupilumab) Eosinophilic Esophagitis Trial Meets Both Co-Primary Endpoints

Lead Product(s): Dupilumab

Therapeutic Area: Gastroenterology Product Name: Undisclosed

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 May 22, 2020

Details:

Dupixent demonstrated significant clinical and anatomic improvements, including the ability to swallow, in Part A of pivotal trial.

Allakos

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United States

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Allakos Announces Multiple Presentations Related to Eosinophil and Mast Cell-Driven Diseases at the Digital EAACI Annual Congress 2020

Lead Product(s): Antolimab

Therapeutic Area: Gastroenterology Product Name: Undisclosed

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 May 21, 2020

Details:

The two abstract will highlight the potential of a A Siglec-8 Antibody to reduce P-induced Inflammation by Inhibiting MRGPR-mediated Mast Cell Activation and Treatment of Severe Allergic Conjunctivitis with Antolimab.

Evoke Pharma

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United States

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Evoke Receives FDA Conditional Acceptance of Gimoti Brand Name Following NDA Resubmission

Lead Product(s): Metoclopramide

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 May 20, 2020

Details:

USFDA has conditionally accepted the proprietary brand name, “Gimoti,” for the Evoke's nasal spray product candidate for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis as resubmitted in the 505 New Drug Application.

Daewoong Pharmaceutical

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Korea, Republic Of

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Daewoong Pharmaceutical Unveils Phase 3 Clinical Data of Fexuprazan, A Novel Potassium-competitive Acid Blocker

Lead Product(s): Fexuprazan

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 May 08, 2020

Details:

In a Phase 3 clinical trial in patients with erosive esophagitis, conducted in 25 hospitals in Korea, Fexuprazan showed 99% of mucosal healing rate at week 8 and was well tolerated in the patients.

Allakos

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United States

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Allakos Announces Interim Results from an Open-Label Extension Study of Antolimab in Eosinophilic Gastritis and/or Eosinophilic Duodenitis

Lead Product(s): Antolimab

Therapeutic Area: Gastroenterology Product Name: Undisclosed

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 May 04, 2020

Details:

Patients treated with antolimab experienced sustained eosinophil depletion in blood and tissue. Blood eosinophil levels rapidly decreased and remained suppressed.

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Find Gastroenterology Drugs in Phase III Clinical Development

Phase III

Product Type

Companies

Sanofi

Sanofi to present growth opportunities and development strategy for Dupixent® (dupilumab) in type 2 inflammatory diseases

Phathom Pharmaceuticals

Phathom Pharmaceuticals Provides Clinical Trial Status Update

Allakos

Allakos Initiates Patient Recruitment for AK002 Registrational Studies

Bristol-Myers Squibb

Bristol Myers Squibb Announces Topline Results from Pivotal Phase 3 True North Trial Evaluating Zeposia in Patients with Moderate to Severe ...

Takeda Pharmaceutical

European Commission Releases Takeda From Commitment to Divest Shire’s Pipeline Compound SHP647

Regeneron Pharmaceuticals

Dupixent® (dupilumab) Eosinophilic Esophagitis Trial Meets Both Co-Primary Endpoints

Allakos

Allakos Announces Multiple Presentations Related to Eosinophil and Mast Cell-Driven Diseases at the Digital EAACI Annual Congress 2020

Evoke Pharma

Evoke Receives FDA Conditional Acceptance of Gimoti Brand Name Following NDA Resubmission

Daewoong Pharmaceutical

Daewoong Pharmaceutical Unveils Phase 3 Clinical Data of Fexuprazan, A Novel Potassium-competitive Acid Blocker

Allakos

Allakos Announces Interim Results from an Open-Label Extension Study of Antolimab in Eosinophilic Gastritis and/or Eosinophilic Duodenitis