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Weekly Top News – IBD – October 28, 2019

October 28, 2019

Stelara (ustekinumab) / J&J
Janssen announces U.S. FDA approval of Stelara (ustekinumab) for the treatment of adults with moderately to severely active ulcerative colitis (PRNewswire) – Oct 21, 2019 – “The Janssen Pharmaceutical Companies…announced today the U.S. Food and Drug Administration’s (FDA) approval of STELARA® (ustekinumab) for the treatment of adult patients with moderately to severely active ulcerative colitis. The approval for this new indication is based on the pivotal Phase 3 UNIFI clinical trial which achieved its primary endpoint of clinical remission.”

 

filgotinib (GLPG0634) / Gilead
Filgotinib: Data from P2b/3 SELECTION1 trial (NCT02914522) for ulcerative colitis in Q2 2020 (Gilead) – Oct 25, 2019 – Q3 2019 Results 
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etrasimod (APD334) / Arena
Etrasimod clinical trial estimate: Initiation of P2b/3 CULTIVATE trial for Crohn’s disease in Q4 2019 (Cantor Fitzgerald) – Oct 21, 2019 – A subscription to Thomson ONE is required to gain full access to report 68024735; Page no: 3; REPORT TITLE: “Companies, catalysts and controversies: Top questions for management at our upcoming global healthcare conference”; AUTHOR: Research Department; DATE: 09/29/2019

 

Stelara (ustekinumab) / J&J
Stelara (ustekinumab) data demonstrate long-term efficacy and safety results in adults with moderately to severely active ulcerative colitis in phase 3 extension trial (Businesswire) – Oct 21, 2019 – P3, N=399; UNIFI (NCT02407236); Sponsor: Janssen Research & Development, LLC; “The Janssen Pharmaceutical Companies…announced new two-year data from the long-term extension of the Phase 3 UNIFI study, demonstrating the efficacy and safety of ustekinumab through two years of treatment in adults with moderately to severely active ulcerative colitis (UC). These data are being presented today as a late-breaking data presentation (LB01) at the 27th UEGW congress…Results showed that the majority of patients were able to sustain remission through to week 92 as assessed by symptomatic remission…Results from the UNITI Crohn’s disease (CD) clinical trial programme are also being presented at the congress.”

 

etrasimod (APD334) / Arena
Arena Pharmaceuticals presented new data analyses demonstrating the long-term safety and efficacy of once-daily etrasimod in patients with moderately to severely active ulcerative colitis at UEG Week (PRNewswire) – Oct 22, 2019 – P2, N=156; OASIS (NCT02447302); Sponsor: Arena Pharmaceuticals; “Arena Pharmaceuticals, Inc…resented new open-label extension data from the Phase 2 OASIS trial for its investigative drug candidate etrasimod…in patients with moderately to severely active ulcerative colitis (UC) at the 25th Annual United European Gastroenterology (UEG) Week…’We are delighted to see that most patients who achieved clinical response, clinical remission, or endoscopic improvement at week 12 experienced sustained or improved effects up to week 46….Etrasimod also demonstrated a favorable safety profile, consistent with safety findings reported in the double-blind portion of OASIS,'”

 

mirikizumab (LY3074828) / Eli Lilly
Mirikizumab: Primary completion of P3 VIVID-1 trial (NCT03926130) for Crohn’s disease in Feb 2022 (Eli Lilly) – Oct 23, 2019 – Q3 2019 Results: Completion of P3 VIVID-1 trial for Crohn’s disease in Jul 2023; Completion of P3 OASIS-1 trial (NCT03482011) in moderate-to-severe plaque psoriasis in Feb 2020 
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mirikizumab (LY3074828) / Eli Lilly
Mirikizumab: Primary completion of P3 LUCENT 1 trial (NCT03518086) in moderate-to-severe ulcerative colitis in Sep 2020 (Eli Lilly) – Oct 23, 2019 – Q3 2019 Results: Completion of P3 LUCENT 1 trial in moderate-to-severe ulcerative colitis in Dec 2021; Primary completion and completion of P2 SHINE 1 trial (NCT04004611) in children and teenagers with ulcerative colitis in Aug 2022 
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mirikizumab (LY3074828) / Eli Lilly
Mirikizumab: Primary completion of P3 LUCENT 2 trial (NCT03524092) in moderate-to-severe ulcerative colitis in Jun 2021 (Eli Lilly) – Oct 23, 2019 – Q3 2019 Results: Completion of P3 LUCENT 2 trial in moderate-to-severe ulcerative colitis in Jun 2023; Primary completion and completion of P3 LUCENT 3 trial (NCT03519945) in moderate-to-severe ulcerative colitis in Aug 2023 
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Myoconda (clarithromycin/clofazimine/rifabutin) / RedHill
RedHill Biopharma to present new phase 3 data on RHB-105 and RHB-104 at the American College of Gastroenterology 2019 Annual Meeting (GlobeNewswire) – Oct 28, 2019 – “RedHill Biopharma Ltd…announced that two oral presentations and two posters on two of the Company’s leading drug candidates, RHB-1051 (Talicia®, H. pylori infection) and RHB-104 (Crohn’s disease) will be presented at the American College of Gastroenterology (ACG) 2019 Annual Scientific Meeting, being held October 25-30, in San Antonio, Texas.”

 

etrasimod (APD334) / Arena
Etrasimod US sales projection: $665M peak for ulcerative colitis (Cantor Fitzgerald) – Oct 21, 2019 – A subscription to Thomson ONE is required to gain full access to report 68047432; Page no: 2; REPORT TITLE: “Arena Pharmaceuticals Inc – Management dinner takeaways”; AUTHOR: Research Department; DATE: 10/03/2019

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