Weekly Top News – IBD – May 11, 2020

filgotinib (GLPG0634) / Gilead
Filgotinib: Data from P2b/3 SELECTION1 trial (NCT02914522) for ulcerative colitis in Q2 2020 (Galapagos) – May 8, 2020 – Q1 2020 Results


brazikumab (AMG 139) / AbbVie
AbbVie and Allergan receive clearance from U.S. Federal Trade Commission for AbbVie’s acquisition of Allergan (AbbVie Press Release) – May 5, 2020 – “AbbVie…and Allergan…announced that the U.S. Federal Trade Commission (FTC) has accepted the proposed consent order in connection with AbbVie’s pending acquisition of Allergan. The acceptance by the FTC satisfies all required antitrust clearances needed to be obtained for the acquisition of Allergan by AbbVie. As part of the proposed consent, Allergan has agreed to divest brazikumab, an investigational IL-23 inhibitor in development for autoimmune diseases, to AstraZeneca and Zenpep, a treatment for exocrine pancreatic insufficiency due to cystic fibrosis and other conditions, to Nestle. Nestle also will be acquiring Viokace, another pancreatic enzyme preparation, as part of the same transaction.”


etrolizumab (RG7413) / Roche
LAUREL: A Study of the Efficacy and Safety of Etrolizumab Treatment in Maintenance of Disease Remission in Ulcerative Colitis (UC) Participants Who Are Naive to Tumor Necrosis Factor (TNF) Inhibitors (clinicaltrials.gov) – May 5, 2020 – P3; N=359; Completed; Sponsor: Hoffmann-La Roche; Active, not recruiting –> Completed; Trial completion date: Jul 2020 –> Apr 2020


TD-1473 / J&J
TD-1473: Data from P2 DIONE trial (NCT03635112) for Crohn’s disease in 2021 (Theravance) – May 7, 2020 – Q1 2020 Results: Data from P2b portion of P2b/3 RHEA trial (NCT03758443) for ulcerative colitis in 2021


etrolizumab (RG7413) / Roche
HICKORY: A Study of the Efficacy and Safety of Etrolizumab in Participants With Ulcerative Colitis Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors (clinicaltrials.gov) – May 8, 2020 – P3; N=609; Completed; Sponsor: Hoffmann-La Roche; Active, not recruiting –> Completed


Entyvio SC (vedolizumab SC) / Takeda
European Commission approves subcutaneous formulation of Entyvio (vedolizumab) for use as maintenance therapy in adults with moderately to severely active ulcerative colitis or Crohn’s disease (Takeda Press Release) – May 8, 2020 – “Takeda Pharmaceutical Company Limited…today announced that the European Commission has granted a Marketing Authorization for the subcutaneous (SC) formulation of Entyvio (vedolizumab), a gut-selective biologic for use as maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD). Entyvio SC will be made available in both a pre-filled syringe and a pre-filled pen….This decision by the European Commission means that Entyvio SC is now approved for use in the 27 member states of the European Union, plus the United Kingdom, Norway, Liechtenstein and Iceland….In addition to having received approval from the European Commission, Entyvio SC has been submitted for regulatory review with other regulatory authorities worldwide.”


MORF-057 / Morphic Therapeutic
Morphic announces corporate highlights and first quarter 2020 financial results (GlobeNewswire, Morphic Therapeutic) – May 6, 2020 – “Data presented at ECCO Congress support MORF-057 in IBD; IND on track for mid-year. ‘At the ECCO meeting, we presented preclinical data that strongly support the development of our candidate MORF-057, an oral inhibitor of α4β7, which is on track to enter clinical studies for inflammatory bowel disease in the second half of this year. These data demonstrated high specificity for its intended biologic target and mechanistic equivalence to the approved intravenous therapeutic against α4β7, vedolizumab.'”


PN-10-943 / Protagonist Therapeutics
Protagonist Therapeutics reports first quarter financial results and provides corporate update (PRNewswire) – May 7, 2020 – “The results of the PTG-300 beta-thalassemia Phase 2 study will be presented at an upcoming medical conference in the second quarter of 2020….The Company is discontinuing clinical development for PTG-300 in beta-thalassemia and myelodysplastic syndromes….A Phase 2 study of PN-943 in approximately 150 patients with moderate-to-severe ulcerative colitis is currently planned.”


CERC-002 / Sanofi, Kyowa Hakko Kirin, Cerecor
Cerecor reports Q1 2020 results and update (GlobeNewswire, Cerecor Inc.) – May 7, 2020 – “CERC-002 (anti-LIGHT mAb) being developed for pediatric-onset Crohn’s disease expects initial data readout in Q1 2021 with the moratorium placed on endoscopy from the AGA”


filgotinib (GLPG0634) / Gilead
SELECTION1: Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) – May 4, 2020 – P2b; N=1351; Completed; Sponsor: Gilead Sciences; Active, not recruiting –> Completed

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