Weekly Top News – IBD – June 24, 2019

filgotinib (GLPG0634) / Gilead
Filgotinib launch estimate: 2023/2024 for Crohn’s disease in US/EU (J.P. Morgan) – Jun 20, 2019 – A subscription to Thomson ONE is required to gain full access to report 67468537; Page no: 4; REPORT TITLE: “Galapagos NV: Filgotinib US filing scenario analysis suggests balanced risk/ reward into FDA pre-filing discussions”; AUTHOR: Quigley, James, et al; DATE: 06/09/2019

 

etrasimod (APD334) / Arena
ELEVATE UC 12: Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) – Jun 24, 2019 – P3; N=330; Not yet recruiting; Sponsor: Arena Pharmaceuticals

 

etrasimod (APD334) / Arena
Etrasimod launch estimate: 2022 for ulcerative colitis (RBC Capital Markets (Canada)) – Jun 17, 2019 – A subscription to Thomson ONE is required to gain full access to report 67280044; Page no: 2; REPORT TITLE: “Arena Pharmaceuticals, Inc. – Q1:19 post-call: Etras’ Ph3 takes focus with ARNA estimates a year ahead of ours”; AUTHOR: Mackay, Kennen, et al; DATE: 05/08/2019

 

etrasimod (APD334) / Arena
Arena Pharmaceuticals announces first subject dosed in ELEVATE UC 52 global phase 3 trial evaluating etrasimod in ulcerative colitis (Arena Press Release) – Jun 17, 2019 – “Arena…today announced that the first subject has been dosed in ELEVATE UC 52, the first of two pivotal trials within the Phase 3 ELEVATE UC registrational program evaluating etrasimod 2 mg in subjects with moderately to severely active ulcerative colitis (UC). ELEVATE UC 52 is a treat-through trial with a 12-week induction period followed by 40 weeks of maintenance.”

 

Entyvio SC (vedolizumab SC) / Takeda
Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn’s Disease (clinicaltrials.gov) – Jun 17, 2019 – P3; N=644; Completed; Sponsor: Takeda; Active, not recruiting –> Completed; Trial completion date: Dec 2019 –> May 2019

 

vidofludimus (IMU-838) / Immunic
Immunic, Inc. to present previously unpublished data regarding lead program, IMU-838, at the GI Inflammatory Diseases Summit in Boston (PRNewswire) – Jun 24, 2019 – “Immunic…announced that Hella Kohlhof, Ph.D., Chief Scientific Officer of Immunic, will present today previously unpublished data regarding the company’s lead program, IMU-838, at the GI Inflammatory Diseases Summit (GIIDS) in Boston….Preclinical data shows that IMU-838 appears selective towards those T cells producing high amounts of the pro-inflammatory cytokines, IFNγ and IL-17….In a phase 2a clinical study in steroid dependent UC and Crohn’s disease patients, the active moiety of IMU-838 (vidofludimus) has shown activity in the ability to wean off steroids, with a total response rate of 88.5%.”

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