Weekly Top News – IBD– December 23, 2019

Myoconda (clarithromycin/clofazimine/rifabutin) / RedHillRHB-104: “Durable remission weeks 16-52: statistically significant benefit in durable remission on all visits, weeks 16-52, demonstrating an improvement of 100% over placebo”; Crohn’s disease (RedHill) - Dec 19, 2019 - Corporate Presentation [Screenshot]mirikizumab (LY3074828) / Eli LillyMirikizumab: Top-line data from P3 trials LUCENT 1 (NCT03518086), LUCENT 2 (NCT03524092) and LUCENT 3 (NCT03519945) for ulcerative colitis in 2020 (Eli Lilly) - Dec 18, 2019 - 2020 Financial Guidance Call [Screenshot]Remsima SC (infliximab biosimilar SC) / CelltrionCT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - Dec 19, 2019 - P3; N=615; Not yet recruiting; Sponsor: CelltrionXeljanz (tofacitinib) / PfizerXeljanz: “The Committee confirmed that all issues previously identified in this application had been addressed [extension application to introduce a new pharmaceutical form (prolonged-release tablet) associated with a new strength (11 mg), and presented in pack sizes of 28, 30, 90 and 91 tablets]." (EMEA) - Dec 20, 2019 - CHMP Final Minutes for the meeting on 14-17 October 2019: “The Committee adopted a positive opinion by consensus together with the CHMP Assessment Report and translation timetable.”SHP647 / TakedaA Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) (clinicaltrials.gov) - Dec 17, 2019 - P3; N=3384; Recruiting; Sponsor: Shire; N=2453 --> 3384QBECO / Qu biologicsQu Biologics Completes Enrollment in First Stage of Phase 2 Clinical Trial in Moderate to Severe Crohn’s Disease (GlobeNewswire, Qu Biologics, Inc.) - Dec 18, 2019 - "Qu Biologics Inc...is pleased to announce the completion of enrollment for the first stage of the RESTORE clinical trial, 'A Phase 2...Study of QBECO SSI for the Induction and Maintenance of Clinical and Endoscopic Remission in Subjects with Moderate to Severe Crohn’s Disease'. In this open-label first stage of a 170-patient study, 20 patients with moderate to severe Crohn’s disease will be treated for up to 52 weeks with the novel investigational agent, QBECO SSI, which is designed to restore, rather than suppress, immune function."ravagalimab (ABBV-323) / AbbVieA Study to Investigate How Well ABBV-323 Works and How Safe it is in Participants With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy (clinicaltrials.gov) - Dec 19, 2019 - P2; N=30; Recruiting; Sponsor: AbbVie; N=60 --> 30; Trial completion date: May 2022 --> Nov 2021ABX464 / AbivaxOpen-label maintenance therapy in moderate to severe Ulcerative Colitis patients Odslepená udržiavacia liečba pacientov so stredne závažnou až závažnou ulceróznou kolitídou (clinicaltrialsregister.eu) - Dec 19, 2019 - P2; N=232; Ongoing; Sponsor: ABIVAX