Weekly Top News – IBD – April 22, 2019

etrolizumab (RG7413) / Roche
Etrolizumab: NME submission for ulcerative colitis in US in 2021 (Roche) – Apr 17, 2019 – Q1 2019 Results: Regulatory submission for ulcerative colitis in EU in 2021; Regulatory submissions for Crohn’s disease in US and EU in 2022 or later
BLA • European regulatory
[Screenshot]

 

TD-1473 / J&J
TD-1473 clinical estimate: Data from P2b/3 RHEA trial (NCT03758443) for ulcerative colitis in 2020 (Cantor Fitzgerald) – Apr 17, 2019 – A subscription to Thomson ONE is required to gain full access to report 67081612; Page no: 1; REPORT TITLE: “Theravancer Biopharma Inc – Don’t get JAK’d, invest in the right one”; AUTHOR: Research Department; DATE: 04/09/2019
P2/3 data

 

TD-1473 / J&J
TD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) Study (clinicaltrials.gov) – Apr 18, 2019 – P2/3; N=500; Not yet recruiting; Sponsor: Theravance Biopharma
Clinical • New P2/3 trial

 

ozanimod (RPC1063) / Celgene
To Evaluate Efficacy and Long-term Safety of Ozanimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) – Apr 16, 2019 – P2/3; N=195; Not yet recruiting; Sponsor: Celgene
Clinical • New P2/3 trial

 

filgotinib (GLPG0634) / Gilead
Filgotinib clinical trial estimate: Data from P2 Divergence2 trial (NCT03077412) for Crohn’s disease in mid-2019 (RBC Capital Markets (Canada)) – Apr 18, 2019 – A subscription to Thomson ONE is required to gain full access to report 67047741; Page no: 2; REPORT TITLE: “Galapagos NV – Takeaways from the road: High aspirations following FINCH data”; AUTHOR: Abrahams, Brian, et al; DATE: 04/04/2019
P2 data

 

filgotinib (GLPG0634) / Gilead
Filgotinib clinical trial estimate: Data from P2 trial (NCT03046056) for small bowel Crohn’s disease in mid-2019 (RBC Capital Markets (Canada)) – Apr 18, 2019 – A subscription to Thomson ONE is required to gain full access to report 67047741; Page no: 2; REPORT TITLE: “Galapagos NV – Takeaways from the road: High aspirations following FINCH data”; AUTHOR: Abrahams, Brian, et al; DATE: 04/04/2019
P2 data

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Expanded Access to Risankizumab (clinicaltrials.gov) – Apr 16, 2019 – P; N=N/A; Available; Sponsor: AbbVie
New trial

 

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