Gastroenterology | Phase III Developments

Sanofi

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FRANCE France

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TIDES - 2020

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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 .

Vanda Pharmaceuticals

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United States

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TIDES - 2020

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Vanda Pharmaceuticals Provides Update on Tradipitant Development Program

Lead Product(s): Tradipitant

Therapeutic Area: Gastroenterology Product Name: VLY-686

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 August 31, 2020

Details:

Article describes Vanda's Phase II double-blind trial of 152 adults with gastroparesis in the U.S. Patients receiving tradipitant had a significant decrease in nausea score at week 4 compared with placebo, and a significant increase in of nausea-free days at week 4.

InDex Pharmaceuticals

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SWEDEN Sweden

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TIDES - 2020

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InDex Pharmaceuticals Presentst Positive Results of the Conduct Study at Two Leading Medical Conferences

Lead Product(s): Cobitolimod

Therapeutic Area: Gastroenterology Product Name: Kappaproct

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 August 24, 2020

Details:

The CONDUCT study met the primary endpoint with 21.4% of patients in clinical remission at week 6 in the highest dose group receiving 250 mg x 2 cobitolimod, compared with 6.8% of patients in the placebo group.

F. Hoffmann-La Roche

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Switzerland

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TIDES - 2020

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Roche Provides Update on Phase III Studies of Etrolizumab In People with Moderately to Severely Active Ulcerative Colitis

Lead Product(s): Etrolizumab,Adalimumab

Therapeutic Area: Gastroenterology Product Name: RG7413

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 August 10, 2020

Details:

Etrolizumab met its primary endpoint of inducing remission versus placebo for people with ulcerative colitis in only two of three studies.

Arena Pharmaceuticals

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United States

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TIDES - 2020

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Arena Reports Second Quarter Financial Results with Strong Liquidity Position, and Maintained Pipeline Progress Over the Quarter

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 August 05, 2020

Details:

Etrasimod ELEVATE UC 52 Phase 3 trial in ulcerative colitis (UC) ongoing and on track; ELEVATE UC 12 Phase 3 trial expected to initiate in H2 2020; topline data for both trials expected by year end 2021.

Ironwood Pharmaceuticals

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United States

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TIDES - 2020

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Ironwood Announces Updates Designed to Strengthen IW-3718 Phase III Program for Refractory Gastroesophageal Reflux Disease (GERD)

Lead Product(s): Colesevelam

Therapeutic Area: Gastroenterology Product Name: IW-3718

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 July 21, 2020

Details:

The primary endpoint for the two identical trials – IW-3718-301 and IW-3718-302 – has been changed from the previous responder endpoint to a continuous endpoint.

Vanda Pharmaceuticals

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United States

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TIDES - 2020

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FDA Grants Authorization for Individual Patient Expanded Access Protocol for the use of Tradipitant for Gastroparesis

Lead Product(s): Tradipitant

Therapeutic Area: Gastroenterology Product Name: VLY-686

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 July 13, 2020

Details:

The patient and treating physician requested expanded access to continue treatment beyond 12 weeks, as the treating physician had judged that tradipitant was the only treatment that effectively managed the patient's gastroparesis symptoms.

9 Meters Biopharma

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United States

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TIDES - 2020

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9 Meters Biopharma, Inc. Amends Definition of Primary Endpoint for Phase 3 Trial in Celiac Disease After Consultation with FDA

Lead Product(s): Larazotide Acetate

Therapeutic Area: Gastroenterology Product Name: INN-202

Highest Development Status: Phase III Product Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 29, 2020

Details:

The trial is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of larazotide for patients with celiac disease who continue to experience gastrointestinal symptoms while following a gluten-free diet.

Soligenix

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United States

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TIDES - 2020

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Soligenix Completes Enrollment in Phase 3 DOM-INNATE Trial of SGX942 to Treat Oral Mucositis

Lead Product(s): Dusquetide

Therapeutic Area: Gastroenterology Product Name: SGX942

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 24, 2020

Details:

Soligenix has completed patient enrollment in its Phase 3 DOM-INNATE ("Dusquetide treatment in Oral Mucositis – by modulating INNATE Immunity") study for SGX942 (dusquetide) in the treatment of oral mucositis (OM) in head and neck cancer (HNC) patients.

Phathom Pharmaceuticals

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United States

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TIDES - 2020

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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.

Find

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

Vanda Pharmaceuticals

Vanda Pharmaceuticals Provides Update on Tradipitant Development Program

InDex Pharmaceuticals

InDex Pharmaceuticals Presentst Positive Results of the Conduct Study at Two Leading Medical Conferences

F. Hoffmann-La Roche

Roche Provides Update on Phase III Studies of Etrolizumab In People with Moderately to Severely Active Ulcerative Colitis

Arena Pharmaceuticals

Arena Reports Second Quarter Financial Results with Strong Liquidity Position, and Maintained Pipeline Progress Over the Quarter

Ironwood Pharmaceuticals

Ironwood Announces Updates Designed to Strengthen IW-3718 Phase III Program for Refractory Gastroesophageal Reflux Disease (GERD)

Vanda Pharmaceuticals

FDA Grants Authorization for Individual Patient Expanded Access Protocol for the use of Tradipitant for Gastroparesis

9 Meters Biopharma

9 Meters Biopharma, Inc. Amends Definition of Primary Endpoint for Phase 3 Trial in Celiac Disease After Consultation with FDA

Soligenix

Soligenix Completes Enrollment in Phase 3 DOM-INNATE Trial of SGX942 to Treat Oral Mucositis

Phathom Pharmaceuticals

Phathom Pharmaceuticals Provides Clinical Trial Status Update