Weekly Top News – IBD– January 20, 2020

mirikizumab (LY3074828) / Eli Lilly
VIVID-2: A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn’s Disease (clinicaltrials.gov) – Jan 18, 2020 – P3; N=778; Not yet recruiting; Sponsor: Eli Lilly and Company

 

filgotinib (GLPG0634) / Gilead
Filgotinib US regulatory estimate: Submission for ulcerative colitis in H2 2020 (Wells Fargo) – Jan 18, 2020 – A subscription to Thomson ONE is required to gain full access to report 68595639; Page no: 21; REPORT TITLE: “Biotech sector outlook – Fundamental/strategic value outweighs E”; AUTHOR: Birenchenough, James, et al; DATE: 01/05/2020

 

etrasimod (APD334) / Arena
Etrasimod: Data from P3 trial for Crohn’s disease in 2022 (Arena) – Jan 16, 2020 – Corporate Presentation
P3 data
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etrasimod (APD334) / Arena
Etrasimod: Completion of enrollment of P3 ELEVATE UC 52 trial (NCT03945188) for ulcerative colitis in 2020 (Arena) – Jan 16, 2020 – Corporate Presentation: Data from P3 ELEVATE UC 12 trial (NCT03996369) for ulcerative colitis in 2021 
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etrasimod (APD334) / Arena
Etrasimod: NDA submission for ulcerative colitis in 2022 (Arena) – Jan 16, 2020 – Corporate Presentation 
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etrasimod (APD334) / Arena
A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn’s Disease (clinicaltrialsregister.eu) – Jan 16, 2020 – P2; N=225; Ongoing; Sponsor: Arena Pharmaceuticals Inc.

 

Entyvio (vedolizumab) / Takeda
Takeda’s Quintiles [sic] expands indication for ulcerative colitis, Crohn’s disease (Korea Biomedical Review) – Jan 17, 2020 – “The Ministry of Food and Drug Safety recently granted the nod to Quintiles [sic] (ingredient: vedolizumab) as the first-line therapy for ulcerative colitis and Crohn’s disease….In recent trials, Quintiles [sic] showed statistically superior clinical remission, compared to existing TNF-alpha inhibitors.”

 

Humira (adalimumab) / Eisai, AbbVie
Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) – Jan 15, 2020 – P3; N=101; Completed; Sponsor: AbbVie; Active, not recruiting –> Completed; Trial completion date: Sep 2020 –> Dec 2019; Trial primary completion date: Jun 2020 –> Dec 2019

 

Humira (adalimumab) / Eisai, AbbVie
Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) – Jan 18, 2020 – P3; N=101; Active, not recruiting; Sponsor: AbbVie; Completed –> Active, not recruiting

 

Xeljanz (tofacitinib) / Pfizer
Xeljanz patent expiry: Late 2025 in US (RBC Capital Markets (Canada)) – Jan 17, 2020 – A subscription to Thomson ONE is required to gain full access to report 68599422; Page no: 13; REPORT TITLE: “Pfizer Inc. – P&L to inflect off more innovative high growth base; Initiate at OP, $46 target”; AUTHOR: Stanicky, Randall, et al; DATE: 01/06/2020

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