Weekly Top News – IBD – February 17, 2020

February 17, 2020
Inflammatory Bowel Disease

etrolizumab (RG7413) / RocheEtrolizumab clinical trial estimate: Data from P3 HIBISCUS 2 trial (NCT02171429) for TNF naive ulcerative colitis in mid-2020 (J.P. Morgan) - Feb 15, 2020 - A subscription to Thomson ONE is required to gain full access to report 68787838; Page no: 3; REPORT TITLE: - “Roche: Strong year of newsflow offers significant potential for earnings upgrades”; AUTHOR: Vosser, Richard, et al; DATE: 02/03/2020etrolizumab (RG7413) / RocheEtrolizumab clinical trial estimate: Data from P3 GARDENIA trial (NCT02136069) for moderate to severe ulcerative colitis in mid-2020 (J.P. Morgan) - Feb 15, 2020 - A subscription to Thomson ONE is required to gain full access to report 68787838; Page no: 3; REPORT TITLE: - “Roche: Strong year of newsflow offers significant potential for earnings upgrades”; AUTHOR: Vosser, Richard, et al; DATE: 02/03/2020etrolizumab (RG7413) / RocheEtrolizumab clinical trial estimate: Data from P3 trials LAUREL (NCT02165215), HICKORY (NCT02100696) and HIBISCUS 1 (NCT02163759) for ulcerative colitis in mid-2020 (J.P. Morgan) - Feb 15, 2020 - A subscription to Thomson ONE is required to gain full access to report 68787838; Page no: 3; REPORT TITLE: - “Roche: Strong year of newsflow offers significant potential for earnings upgrades”; AUTHOR: Vosser, Richard, et al; DATE: 02/03/2020carotegrast methyl (AJM300) / Kissei, EisaiAJM300 clinical trial estimate: Data from P3 trial (NCT03531892) for ulcerative colitis in H2 2020 (J.P. Morgan) - Feb 17, 2020 - A subscription to Thomson ONE is required to gain full access to report 68874313; Page no: 11; REPORT TITLE: "European Pharma & Biotech: Flushing out the UC opportunity: ROG's etrolizumab seems well positioned, GLGP's filgotinib could be less differentiated”; AUTHOR: Vosser, Richard, et al; DATE: 02/13/2020Stelara (ustekinumab) / J&JNew phase 3b interim data from STARDUST study show two-thirds of patients with moderately to severely active Crohn’s disease achieved clinical remission after two doses of Stelara (ustekinumab) (PRNewswire) - Feb 14, 2020 - P3b, N=500; STARDUST (NCT03107793); Sponsor: Janssen-Cilag Ltd.; "The Janssen Pharmaceutical Companies of Johnson & Johnson today announced interim data from the Phase 3b STARDUST study. At week 16, 79 percent of patients with moderately to severely active Crohn's disease (CD) achieved clinical response and 67 percent were in clinical remission...Week 16 data (digital oral presentation, or DOP 13) and IUS response data (DOP 10) from STARDUST are being presented as digital oral presentations at the 15th Congress of the European Crohn's & Colitis Organization (ECCO)....Janssen is presenting a total of 23 abstracts at this year's ECCO congress."Entyvio (vedolizumab) / TakedaInvestigational subcutaneous formulation of vedolizumab achieves clinical remission at week 52 in patients with moderately to severely active Crohn’s disease (Businesswire) - Feb 14, 2020 - P3, N=383; VISIBLE 2 (NCT02611830); Sponsor: Takeda; "Takeda Pharmaceutical Company Limited...today announced results from the phase 3 VISIBLE 2 clinical trial evaluating the efficacy and safety of an investigational subcutaneous (SC) formulation of the...vedolizumab (Entyvio®) for use during maintenance therapy in adult patients with moderately to severely active Crohn's disease (CD)....The results show that at week 52, significantly more patients on vedolizumab SC compared to placebo were in clinical remission (48.0% [n=132/275] vs. 34.3% [n=46/134] respectively; [p=0.008])...These data were announced during an oral presentation at the 15th Congress of the European Crohn’s and Colitis Organisation (ECCO) in Vienna, Austria."Humira (adalimumab) / Eisai, AbbVieStudy to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's Disease (clinicaltrials.gov) - Feb 11, 2020 - P3; N=514; Completed; Sponsor: AbbVie; Active, not recruiting --> Completedetrasimod (APD334) / ArenaArena Pharmaceuticals’ presence at the European Crohn’s and Colitis Organisation (ECCO) Congress further highlights commitment to the GI community (Arena Press Release) - Feb 11, 2020 - P2, N=156; NCT02447302; Sponsor: Arena; "Arena Pharmaceuticals...announced it will present new data from the open-label extension (OLE) of the Phase 2 OASIS trial for its investigative drug candidate etrasimod, a next-generation, once-daily, oral, selective sphingosine 1-phosphate (S1P) receptor modulator, at the 15th Annual Congress of the European Crohn's and Colitis Organisation (ECCO). The congress is taking place February 12-15, 2020, in Vienna, Austria....Arena is presenting additional data on etrasimod and the unmet need in IBD, as well as hosting a dinner symposium with focused discussion on the integration of histology into a treat-to-target strategy."