Weekly Top News – IBD – July 29, 2019

etrolizumab (RG7413) / Roche
Etrolizumab clinical trial estimate: Data from P3 HICKORY trial (NCT02100696) for ulcerative colitis in Q4 2019 (Barclays) – Jul 23, 2019 – A subscription to Thomson ONE is required to gain full access to report 67625398; Page no: 117; REPORT TITLE: “European Pharmaceuticals: The weekly check-up”; AUTHOR: Papadakis, Emmanuel, et al; DATE: 07/15/2019


mirikizumab (LY3074828) / Eli Lilly
Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn’s Disease(clinicaltrialsregister.eu) – Jul 23, 2019 – P3; N=1100; Ongoing; Sponsor: Eli Lilly and Company


etrolizumab (RG7413) / Roche
Etrolizumab: NME submission in US for ulcerative colitis in 2020 (Roche) – Jul 26, 2019 – H1 2019 results: Regulatory submission in EU for ulcerative colitis in 2020  


filgotinib (GLPG0634) / Gilead
Filgotinib clinical trial estimate: Data from P2/3 SELECTION1 trial (NCT02914522) for ulcerative colitis in Q2 2020 (Cantor Fitzgerald) – Jul 23, 2019 – A subscription to Thomson ONE is required to gain full access to report 67562661; Page no: 1; REPORT TITLE: “Galapagos NV – The ball is back in GLPG’s court; FDA update lifts key overhang”; AUTHOR: Research Department; DATE: 07/02/2019


Stelara (ustekinumab) / J&J
Janssen receives CHMP positive opinion for Stelara (ustekinumab) recommending approval for the treatment of moderately to severely active ulcerative colitis in the EU (Businesswire) – Jul 26, 2019 – “The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending marketing authorisation in the European Union (EU) for the use of ustekinumab for the treatment of adult patients with moderately to severely active ulcerative colitis (UC), who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies….The CHMP adopted the opinion based on data from the pivotal Phase 3 UNIFI trial programme…Following this positive opinion, a final decision from the European Commission (EC) regarding its marketing authorisation is expected later this year.”


etrolizumab (RG7413) / Roche
Etrolizumab regulatory estimate: Approval for IBD in 2021 (Jefferies) – Jul 24, 2019 – A subscription to Thomson ONE is required to gain full access to report 67604423; Page no: 25; REPORT TITLE: “Astrazeneca: Pharma Quarterly: Stock catalysts, models & valuation”; AUTHOR: Welford, Peter, et al; DATE: 07/10/2019


Imraldi (adalimumab biosimilar) / Biogen, Merck (MSD), Samsung
FDA approves Samsung Bioepis’ Hadlima (adalimumab-bwwd) (Businesswire) – Jul 24, 2019 – “Samsung Bioepis…announced that the US Food and Drug Administration (FDA) has approved HADLIMA™ (adalimumab-bwwd), a biosimilar referencing HUMIRA® (adalimumab), for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis.”


Entyvio SC (vedolizumab SC) / Takeda
Investigational subcutaneous formulation of vedolizumab meets primary endpoint in achieving clinical remission at week 52 in patients with moderately to severely active Crohn’s disease(Businesswire) – Jul 22, 2019 – P3, N=644; VISIBLE 2 (NCT02611817); Sponsor: Takeda; “In evaluating the primary endpoint of the trial, a statistically significant proportion of patients receiving vedolizumab SC achieved clinical remission at week 52 compared to placebo. Patients received vedolizumab SC beginning at week 6 and every 2 weeks up to week 50. Adverse events were consistent with the known safety profile of vedolizumab IV, and no new signals were identified.”


Xeljanz (tofacitinib) / Pfizer
Xeljanz, Xeljanz XR (tofacitinib): Drug safety communication – due to an increased risk of blood clots and death with higher dose (EIN News) – Jul 26, 2019 – “FDA has approved new warnings about an increased risk of blood clots and of death with the 10 mg twice daily dose of Xeljanz, Xeljanz XR (tofacitinib), which is used in patients with ulcerative colitis. In addition, the approved use of tofacitinib for ulcerative colitis will be limited to certain patients who are not treated effectively or who experience severe side effects with certain other medicines. We approved these changes, including adding our most prominent Boxed Warning, after reviewing interim data from an ongoing safety clinical trial of tofacitinib in patients with rheumatoid arthritis (RA)…”


VE-202 / J&J, Vedanta Biosciences
VE-202: PK/PD data from P1 trial in healthy subjects in 2019 (Puretech) – Jul 26, 2019 – Corporate Presentation  


cannabidiol solution (ST-SDCD-01) / STERO Biotechs
Stero Biotechs to commence phase 2a clinical trial of cannabidiol-based formulation for patients with Crohn’s disease (PRNewswire) – Jul 23, 2019 – “Stero Biotechs…received its second Helsinki approval to move forward with a second Phase 2a clinical trial. The trial will be a randomized, double-blind, placebo-controlled, multicenter study of ST-SDCD-01, a CBD based solution in an effort to lower the steroid dosage in patients with Steroid Dependent Crohn’s Disease (SDCD).”

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