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Weekly Top News – IBD – November 11, 2019

November 11, 2019

Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine
Xifaxan: Initiation of P2/3 trial for Crohn’s disease in H1 2020 (Bausch Health) – Nov 5, 2019 – Q3 2019 Results 
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amiselimod (MT 1303) / Mitsubishi Tanabe, Bausch Health
Amiselimod: Initiation of P2 trial for ulcerative colitis in H1 2020 (Bausch Health) – Nov 5, 2019 – Q3 2019 Reuslts 
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PTG-200 / Protagonist Therapeutics, J&J
Protagonist Therapeutics announces first patient dosed in a phase 2 study of oral IL-23 receptor antagonist PTG-200 (JNJ-67864238) in the treatment of Crohn’s disease (PRNewswire) – Nov 6, 2019 – P2, N=90; PRISM (NCT04102111); Sponsor: Janssen Research & Development, LLC; “Protagonist Therapeutics, Inc. (Nasdaq:PTGX) today announced that the first patient has been dosed in a Phase 2 study of PTG-200 (also referenced as JNJ-67864238) in patients with moderate to severe Crohn’s disease…The global, randomized, double blind, placebo-controlled, Phase 2 study is evaluating the efficacy of oral administration of PTG-200 in 90 patients with moderate to severe Crohn’s disease…Clinical efficacy results for the Janssen Collaboration Asset are expected in 2021.”

filgotinib (GLPG0634) / Gilead
Filgotinib sales projection: $5.9B peak for rheumatoid arthritis, $2.6B for ankylosing spondylitis, $1.1B for ulcerative colitis, $870M for psoriatic arthritis and $790M in Crohn’s disease by 2030 (Morgan Stanley) – Nov 6, 2019 – A subscription to Thomson ONE is required to gain full access to report 68200745; Page no: 3; REPORT TITLE: “Galapagos NV: MOR106 Stopped for futility.”; AUTHOR: Harrison, Matthew, et al; DATE: 10/28/2019

 

etrolizumab (RG7413) / Roche
A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors (Study #2) (clinicaltrials.gov) – Nov 10, 2019 – P3; N=350; Recruiting; Sponsor: Hoffmann-La Roche; Trial completion date: Dec 2020 –> Jul 2020; Trial primary completion date: Oct 2020 –> Mar 2020

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi sales projection: $275M in 2020 (Wolfe Research) – Nov 8, 2019 – A subscription to Thomson ONE is required to gain full access to report 68243153; Page no: 2; REPORT TITLE: “Abbvie Inc Global Pharmaceuticals – ABBV: 3Q19 – They just said what?! Highlights from conference call that just ended”; AUTHOR: Anderson, Tim, et al; DATE: 11/01/2019

 

Entyvio (vedolizumab) / Takeda
Entyvio sales projection: $3.1B in FY2019 (Cowen & Co) – Nov 6, 2019 – A subscription to Thomson ONE is required to gain full access to report 68241376; Page no: 19; REPORT TITLE: “Takeda Pharaceutical Co Ltd- Initiating coverage: Initiation: management is executing but pressures on key franchises outweigh”; AUTHOR: Cacciatore, Ken, et al; DATE: 11/01/2019

 

Rinvoq (upadacitinib) / AbbVie
A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn’s Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy (clinicaltrials.gov) – Nov 4, 2019 – P3; N=645; Recruiting; Sponsor: AbbVie; Trial completion date: Feb 2021 –> Jun 2021; Trial primary completion date: Feb 2021 –> Jun 2021

 

Xeljanz (tofacitinib) / Pfizer
Health puts restrictions on Xeljanz (Pfizer) for risk of thromboembolism [Google Translation] (Redacción Médica) – Nov 6, 2019 – “The Agency for Medicines and Health Products ( Aemps ) has announced new restrictions on the use of Xeljanz, Pfizer medication with tofacitinib as an active ingredient that is indicated for various inflammatory diseases such as arthritis. This decision of the Aemps is motivated after the review carried out by the Committee for Risk Assessment in European Pharmacovigilance (PRAC ) on this drug.”

 

READ-UC: Real World Study Of The Clinical Profile And Treatment Outcomes Of Advanced Therapies For Ulcerative Colitis In Portugal (clinicaltrials.gov) – Nov 7, 2019 – P; N=310; Not yet recruiting; Sponsor: Pfizer

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