Drugs / Ontamalimab
Trials 14
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT07052682 | Jan 2023 → Dec 2024 | metabolic dysfunction-associated steatohepatitis | Takeda | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT01387594 | May 2012 → Mar 2014 | ileocolitis, ulcerative colitis | Shire | Completed | No outcome recorded |
| Phase 1 | NCT00928681 | Sep 2005 → Apr 2008 | ulcerative colitis | Pfizer | Completed | No outcome recorded |
| Phase 24 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT01771809 | Mar 2013 → Dec 2017 | ulcerative colitis | Shire | Completed | No outcome recorded |
| Phase 2 | NCT01620255 | Nov 2012 → Sep 2014 | ulcerative colitis | Shire | Completed | Met primary |
| Phase 2 | NCT01298492 | Jul 2011 → Jul 2016 | Crohn disease | Shire | Completed | No outcome recorded |
| Phase 2 | NCT01276509 | Apr 2011 → Feb 2014 | Crohn disease | Shire | Completed | Missed primary |
| Phase 37 trials · 2 met primary | ||||||
| Phase 3 | NCT03627091 | Feb 2019 → Jun 2021 | Crohn disease | Shire | Terminated | Met primary Stop: Business |
| Phase 3 | NCT03559517 | Aug 2018 → Jul 2020 | Crohn disease | Shire | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT03566823 | Jul 2018 → Aug 2020 | Crohn disease | Shire | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT03290781 | Apr 2018 → Jul 2021 | ulcerative colitis | Shire | Completed | Met primary |
| Phase 3 | NCT03283085 | Feb 2018 → Dec 2023 | Crohn disease, ulcerative colitis | Shire | Completed | No outcome recorded |
| Phase 3 | NCT03259334 | Feb 2018 → Jul 2020 | ulcerative colitis | Shire | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT03259308 | Dec 2017 → Jul 2020 | ulcerative colitis | Shire | Terminated | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2020-05-28 | Takeda | Regulatory European Commission Releases Takeda from Commitment to Divest Shire’s Pipeline Compound SHP647 takeda.com ↗
Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announces that on May 28, the European Commission (the “EC”) has released Takeda from the obligation to divest the pipeline compound SHP647 |
| 2018-02-13 | Takeda | Regulatory Shire Provides Regulatory Progress Update for Key Pipeline Programs Targeting Rare Disease takeda.com ↗
Shire plc (LSE: SHP, NASDAQ: SHPG), the global biotechnology leader in rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Shire’s investigational therapy, SHP647, for the treatment of pediatric patients with moderately to severely active Crohn’s disease. |
| 2017-11-30 | Takeda | Regulatory U.S. FDA Grants Shire Orphan Drug Designation for Investigational Anti-MAdCAM Antibody SHP647 for the Treatment of Moderately to Severely Active Ulcerative Colitis in Pediatric Patients takeda.com ↗
Shire plc (LSE: SHP, NASDAQ: SHPG), the world’s leading biotechnology company in rare diseases, today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to Shire’s investigational anti-MAdCAM-1 antibody, SHP647 (formerly known as PF-00547659), for the treatment of pediatric patients with moderately to severely active ulcerative colitis (UC). |
| 2017-05-18 | Takeda | Results The Lancet Publishes Phase 2 Results from Shire’s Investigational Anti-MAdCAM Antibody Showing Significantly Increased Remission Rates in Patients with Moderate-to-Severe Ulcerative Colitis takeda.com ↗
In this Phase 2 study, called TURANDOT, SHP647, the first anti-MAdCAM antibody in clinical development, met its primary endpoint demonstrating significantly greater remission rates in patients receiving anti-MAdCAM antibody compared to placebo in three of four tested dose groups. |
All press releases naming this drug 4 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 16 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ontamalimab | “Ontamalimab (SHP647), a fully human immunoglobulin G2 monoclonal antibody against mucosal addressin cell adhesion molecule-1, is a potential novel CD treatment.” PMID 34427633 ↗ Jul 2022 |
| Known as | PF-00547659 | “PF-00547659 is a human monoclonal antibody that binds to mucosal addressin-cell adhesion molecule 1 (MAdCAM-1) on endothelial cells and blocks its interaction with...” PMID 28778448 ↗ Jun 20175“This first-in-human study of a monoclonal antibody to MAdCAM, PF-00547,659, aimed to explore the safety and preliminary efficacy of this gut-specific mechanism in ulcerative colitis.” PMID 21317177 ↗ Feb 2011 “PF-00547659, single iv dose” NCT00928681 ↗ “75mg SHP647 (PF-00547659)” NCT01771809 ↗ |
| Known as | SHP647 | “Ontamalimab (SHP647), a fully human immunoglobulin G2 monoclonal antibody against mucosal addressin cell adhesion molecule-1, is a potential novel CD treatment.” PMID 34427633 ↗ Jul 2022 |
| Action | Inhibit | “prevents the binding of α4β7+ lymphocytes to MAdCAM-expressing sites in the gastrointestinal tract” PMID 32013314 ↗ Jan 2020 |
| Modality | Monoclonal antibody | “This first-in-human study of a monoclonal antibody to MAdCAM, PF-00547,659” PMID 21317177 ↗ Feb 2011 |
| Route | Intravenous | “doses of PF-00547,659 0.03-10 mg/kg IV/SC” PMID 21317177 ↗ Feb 2011 |
| Route | Subcutaneous | “doses of PF-00547,659 0.03-10 mg/kg IV/SC” PMID 21317177 ↗ Feb 2011 |
| Target | MADCAM1 | “binds to mucosal addressin-cell adhesion molecule 1 (MAdCAM-1) on endothelial cells” PMID 28778448 ↗ Jun 2017 |