sibofimloc (EB8018) / Enterome, Takeda - LARVOL DELTA

A Study of TAK-018 in Preventing the Recurrence of Crohn's Disease After Surgery (clinicaltrials.gov) - P2a | N=34 | Terminated | Sponsor: Takeda | N=96 ➔ 34 | Trial completion date: Jan 2023 ➔ Aug 2022 | Active, not recruiting ➔ Terminated | Trial primary completion date: Dec 2022 ➔ Aug 2022; Sponsor decision to discontinue study due to inability to recruit the expected number of subjects within the requisite time period.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease • TNFA

A Study of TAK-018 in Preventing the Recurrence of Crohn's Disease After Surgery (clinicaltrials.gov) - P2a | N=96 | Recruiting | Sponsor: Takeda | Active, not recruiting ➔ Recruiting | Trial primary completion date: Sep 2022 ➔ Dec 2022

Enrollment open • Trial primary completion date • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease • TNFA

Blockage of bacterial FimH prevents mucosal inflammation associated with Crohn’s disease. (PubMed, Microbiome) - "We propose that TAK-018, which is safe and well tolerated in humans, is a promising candidate for the treatment of CD and in particular in preventing its recurrence. Video abstract."

Journal • Crohn's disease • Gastroenterology • Immunology • Inflammation • Inflammatory Bowel Disease • Mucositis • TLR4

A SAFETY, PHARMACOKINETIC AND PHARMACODYNAMIC STUDY OF SIBOFIMLOC, A NOVEL FIMH BLOCKER IN PATIENTS WITH ACTIVE CROHN’S DISEASE. (PubMed, J Gastroenterol Hepatol) - "This first study of the novel FimH blocker, sibofimloc, in patients with active CD demonstrated minimal systemic exposure with good tolerance, while decreasing several inflammatory biomarkers."

Journal • PK/PD data • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • CXCL8 • IFNG • IL1B • IL6

A Study of TAK-018 in Preventing the Recurrence of Crohn's Disease After Surgery (clinicaltrials.gov) - P2a | N=96 | Active, not recruiting | Sponsor: Takeda | Recruiting ➔ Active, not recruiting

Enrollment closed • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease • TNFA

Sibofimloc: Regulatory approval for Crohn's disease in FY2025 or later (40th Annual J.P. Morgan Healthcare Conference (Virtual Meeting), Takeda)

Regulatory • Crohn's disease • Inflammatory Bowel Disease

Sibofimloc: Regulatory approval for Crohn's disease in FY2025 or later (40th Annual J.P. Morgan Healthcare Conference (Virtual Meeting), Takeda)

Regulatory • Crohn's disease • Inflammatory Bowel Disease

Enterome highlights Microbiome publication describing sibofimloc's novel mechanism of action for the treatment of Crohn's disease (PRNewswire) - "Enterome...announces the publication of a new paper describing the novel mechanism of action of its investigational medicine sibofimloc (also called TAK-018) for the treatment of Crohn's disease (CD) in the high impact peer-reviewed journal Microbiome....In the paper, the authors showed that blocking the adhesion of overabundant FimH-expressing bacteria to the gut wall is a promising therapeutic mechanism that effectively disarms these virulent bacteria without killing them....Sibofimloc was shown to selectively bind and aggregate FimH-expressing bacteria in 65%-85% of ileal biopsies from CD patients. Aggregation of bacteria to sibofimloc led to a strong decrease in inflammation and a general improvement of gut integrity. Furthermore, when used at therapeutically relevant doses, sibofimloc preserved normal gut tissue integrity."

Preclinical • Crohn's disease • Inflammatory Bowel Disease

TAK-018 for Prevention of the Recurrence of Postoperative Crohn's Disease (CD) (clinicaltrials.gov) - P2a; N=96; Recruiting; Sponsor: Millennium Pharmaceuticals, Inc.; Trial completion date: Jun 2022 ➔ Oct 2022; Trial primary completion date: May 2022 ➔ Sep 2022

Clinical • Trial completion date • Trial primary completion date • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease • TNFA

EBFIM117: A Study of a FimH Blocker, EB8018, in Crohn's Disease Patients (clinicaltrials.gov) - P1; N=8; Completed; Sponsor: Enterome; Active, not recruiting ➔ Completed

Clinical • Trial completion • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease

TAK-018 for Prevention of the Recurrence of Postoperative Crohn's Disease (CD) (clinicaltrials.gov) - P2a; N=96; Recruiting; Sponsor: Millennium Pharmaceuticals, Inc.; Trial completion date: Nov 2022 ➔ May 2022

Clinical • Trial completion date • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease • TNFA

Enterome announces first patient dosed in Phase 2a trial of sibofimloc in Crohn's disease (PipelineReview) - "ENTEROME...today announced that the first patient has been dosed in a Phase 2a clinical trial of sibofimloc (EB8018/TAK-018) in patients with Crohn's disease....The primary endpoint of the study is the percentage of participants with endoscopic recurrence of Crohn's disease as assessed by Rutgeerts grading scale at week 26. The trial will take place in the US and Europe and results are expected in 2022."

P2a data • Trial status • Crohn's disease • Immunology • Inflammatory Bowel Disease

TAK-018 for Prevention of the Recurrence of Postoperative Crohn's Disease (CD) (clinicaltrials.gov) - P2a; N=96; Recruiting; Sponsor: Millennium Pharmaceuticals, Inc.; Trial completion date: May 2022 ➔ Nov 2022

Clinical • Trial completion date • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease • TNFA

TAK-018 for Prevention of the Recurrence of Postoperative Crohn's Disease (CD) (clinicaltrials.gov) - P2a; N=96; Recruiting; Sponsor: Millennium Pharmaceuticals, Inc.; Trial completion date: Dec 2021 ➔ May 2022; Trial primary completion date: Nov 2021 ➔ Apr 2022

Clinical • Trial completion date • Trial primary completion date • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease • TNFA

TAK-018 for Prevention of the Recurrence of Postoperative Crohn's Disease (CD) (clinicaltrials.gov) - P2a; N=96; Recruiting; Sponsor: Millennium Pharmaceuticals, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease

Enterome Raises $52.6 Million to Advance Cancer Immunotherapies and OncoMimics Platform (BioSpace) - "Enterome also will use the proceeds to support Takeda Pharmaceutical’s proof-of-concept clinical trial of EB8018 (sibofimloc/TAK-018), an oral FimH blocker for the treatment of Crohn’s disease."

Financing • Crohn's disease • Inflammatory Bowel Disease

Newly added product (Genengnews) - P1, Inflammatory Bowel Disease

Pipeline update • Immunology • Inflammation • Inflammatory Bowel Disease

Takeda to co-develop Enterome Crohn's disease candidate EB8018 (Genengnews) - "Takeda Pharmaceutical has agreed to license, co-develop, and co-promote Enterome’s...Phase Ib Crohn’s disease candidate EB8018, Enterome said...through a collaboration that could generate more than $690 million....Together with Takeda, Enterome plans to launch a Phase II clinical proof-of-concept trial of EB8018 in 2019. The companies are also partnering on a Phase Ib trial (NCT03709628) that has begun recruiting patients....The new trial is intended to support the development of EB8018 as an add-on therapy, for the treatment of adult patients suffering from Crohn's disease."

Licensing / partnership • New P2 trial • Trial status • Crohn's disease • Immunology • Inflammation • Inflammatory Bowel Disease

A PHARMACOKINETIC (PK) AND SAFETY STUDY OF A FIMH BLOCKER, SIBOFIMLOC (TAK-018/EB8018), IN PATIENTS WITH CROHN'S DISEASE (CD) (DDW 2020) - "These preliminary data confirmed that sibofimloc was well tolerated. In the small subset of patients analyzed, there was a slightly higher plasma exposure and inter-patient variability compared with what has been seen earlier in healthy subjects. The safety and PK data allowed the continuation of the clinical development program with the initiation of a phase 2 trial for postoperative maintenance in patients with CD."

Clinical • PK/PD data • Crohn's disease • Gastroenterology • Immunology • Inflammation • Inflammatory Bowel Disease • TLR4

An open-label, multicenter, phase ib, pharmacokinetic (pk) and safety study of a fimh blocker, Sibofimloc (TAK-018/EB8018), in patients with Crohn’s disease (CD) (ECCO-IBD 2020) - "In the small subset of patients analyzed, there was a slightly higher plasma exposure and interpatient variability compared with what has been seen earlier in healthy subjects. The safety and PK data allowed the continuation of the clinical development program with the initiation of a phase 2 trial for postoperative maintenance in patients with CD."

Clinical • PK/PD data

TAK-018 for Prevention of the Recurrence of Postoperative Crohn's Disease (CD) (clinicaltrials.gov) - P2a; N=75; Not yet recruiting; Sponsor: Millennium Pharmaceuticals, Inc.; Trial completion date: Sep 2021 ➔ Dec 2021

Clinical • Trial completion date

EBFIM117: A Study of a FimH Blocker, EB8018, in Crohn's Disease Patients (clinicaltrials.gov) - P1; N=8; Active, not recruiting; Sponsor: Enterome; Trial completion date: Dec 2019 ➔ Oct 2023; Trial primary completion date: Dec 2019 ➔ Jun 2022

Trial completion date • Trial primary completion date

EBFIM117: A Study of a FimH Blocker, EB8018, in Crohn's Disease Patients (clinicaltrials.gov) - P1; N=8; Active, not recruiting; Sponsor: Enterome; Recruiting ➔ Active, not recruiting; Trial completion date: Feb 2019 ➔ Dec 2019; Trial primary completion date: Jan 2019 ➔ Dec 2019

Clinical • Enrollment closed • Trial completion date • Trial primary completion date

TAK-018 for Prevention of the Recurrence of Postoperative Crohn's Disease (CD) (clinicaltrials.gov) - P2a; N=75; Not yet recruiting; Sponsor: Millennium Pharmaceuticals, Inc.; Initiation date: Nov 2019 ➔ Feb 2020

Clinical • Trial initiation date

TAK-018 for Prevention of the Recurrence of Postoperative Crohn's Disease (clinicaltrials.gov) - P2a; N=75; Not yet recruiting; Sponsor: Millennium Pharmaceuticals, Inc.; Trial completion date: May 2021 ➔ Sep 2021; Trial primary completion date: May 2021 ➔ Sep 2021

Clinical • Trial completion date • Trial primary completion date