Drugs / OMODENBAMAB
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT02357966 | May 2015 → Dec 2016 | staphylococcus aureus infection | XBiotech, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2018-01-25 | XBiotech, Inc. | Results XBiotech Publishes Results in PLOS ONE for its True Human Antibody 514G3 Targeting S. aureus xbiotech.com ↗
The present study confirms the mechanism of action of 514G3, and its ability to neutralize and kill the bacteria in a strain-independent manner. |
| 2017-04-03 | XBiotech, Inc. | Results XBiotech Announces Top-Line Results for 514G3 Antibody Therapy in Serious Staphylococcus aureus Infections xbiotech.com ↗ |
| 2016-03-28 | XBiotech, Inc. | Results XBiotech Advances to Phase II Portion of Clinical Study of Novel True Human™ Therapeutic Antibody for Treating Serious Infections Due to Staphylococcus aureus xbiotech.com ↗
The Company reports what it believes is a remarkable finding from the Phase I study, noting that the incidence of serious adverse events (SAE) was 50% less in the treatment arm as compared to placebo. |
| 2016-01-07 | XBiotech, Inc. | Results XBiotech Advances to Final Dosing Cohort in Phase 1/2 Clinical Study of Novel True Human™ Therapeutic Antibody for Treating Serious Infections Due to Staphylococcus aureus xbiotech.com ↗
Safety data review from the second dose cohort revealed no dose limiting toxicities. |
| 2015-10-21 | XBiotech, Inc. | Results XBiotech Presents Findings at Investigator Conference for Staphylococcus Aureus Program xbiotech.com ↗
The Company presented findings that showed a direct correlation with the pharmacokinetics of its antibody therapy and the ability of patient blood to mediate clearance of S. aureus . |
| 2015-10-01 | XBiotech, Inc. | Regulatory XBiotech Receives FDA Fast Track Designation for Its Novel True Human(TM) Therapeutic Antibody for Treating Serious Infections Due to Staphylococcus Aureus xbiotech.com ↗
AUSTIN, Texas , Oct. 1, 2015 (GLOBE NEWSWIRE) -- XBiotech (NASDAQ:XBIT), the world's leading developer of next-generation True Human™ therapeutic antibodies, announced today that the U.S. Food and Drug Administration ( FDA ) has granted Fast Track Designation for its novel True Human monoclonal antibody therapy intended to treat all forms of Staphylococcus aureus infections, including Methicillin-resistant S. aureus (MRSA). |
All press releases naming this drug 6 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | OMODENBAMAB | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594339 ↗ |
| Known as | 514G3 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02357966 ↗ |
| Modality | Monoclonal antibody | “True Human monoclonal antibody 514G3” NCT02357966 ↗ |