Drugs / Bermekimab
Trials 18
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT03207724 | Oct 2017 → Nov 2019 | hypoproteinemia, hypercatabolic, pancreatic ductal adenocarcinoma | Andrew Hendifar, MD | Completed | No outcome recorded |
| Phase 1 | NCT03047317 | Feb → Mar 2017 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01260545 | Apr 2011 → Jun 2012 | hematopoietic and lymphoid cell neoplasm | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01021072 | Mar 2010 → Oct 2012 | high grade malignant neoplasm | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 213 trials · 2 missed | ||||||
| Phase 2 | NCT04988308 | Oct 2021 → Oct 2022 | hidradenitis suppurativa | Janssen Research & Development, LLC | Terminated | No outcome recorded |
| Phase 2 | NCT04990440 | Sep 2021 → Mar 2022 | atopic eczema | Janssen Research & Development, LLC | Terminated | No outcome recorded |
| Phase 2 | NCT04791319 | May 2021 → Feb 2022 | atopic eczema | Janssen Research & Development, LLC | Terminated | Missed primary |
| Phase 2 | NCT04021862 | Oct 2019 → Jun 2020 | atopic eczema | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT04019041 | Sep 2019 → May 2020 | hidradenitis suppurativa | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT04045743 | Jul 2019 → Jan 2021 | systemic sclerosis | Hellenic Institute for the Study of Sepsis | Completed | No outcome recorded |
| Phase 2 | NCT03512275 | Jun 2018 → Jan 2019 | hidradenitis suppurativa | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT03496974 | May → Dec 2018 | atopic eczema | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT01965613 | Jan 2014 → Dec 2016 | pyoderma gangrenosum | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT01474798 | Feb → Oct 2012 | acne | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT01384630 | Sep 2011 → Jul 2012 | psoriasis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT01270945 | Jun 2011 → Sep 2013 | peripheral arterial occlusive disease 1 | Janssen Research & Development, LLC | Completed | Missed primary |
| Phase 2 | NCT01427699 | Jun 2011 → Oct 2012 | type 2 diabetes mellitus | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 31 trial · 1 missed | ||||||
| Phase 3 | NCT01767857 | Mar 2013 → Jun 2017 | colorectal cancer | Janssen Research & Development, LLC | Terminated | Missed primary |
| Comparator or background therapy2 trials | ||||||
| Phase 2 | NCT02643654 Comparator | Dec 2015 → Oct 2016 | hidradenitis suppurativa | Evangelos J. Giamarellos-Bourboulis, M.D. | Completed | No outcome recorded |
| Phase 3 | NCT02138422 Comparator | Jul 2014 → Nov 2015 | colorectal cancer | Janssen Research & Development, LLC | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 2019-05-02 | XBiotech, Inc. | Results XBiotech Announces Enrollment Completion, Positive Findings for Bermekimab in Pancreatic Cancer Study xbiotech.com ↗
Therapeutic activity and patient outcomes appear to be favorable when compared to similar pancreatic cancer patient populations refractory to therapy. |
| 2019-01-23 | XBiotech, Inc. | Results Bermekimab Successfully Treats Hidradenitis Suppurativa, Including Significant Reduction in Pain xbiotech.com ↗
XBiotech (NASDAQ: XBIT) announced today the successful outcome of its multicenter, open label, confirmatory study using bermekimab to treat patients with moderate to severe Hidradenitis Suppurativa (HS). |
| 2018-08-27 | XBiotech, Inc. | Results XBiotech Announces Publication of Breakthrough Findings for Potential Role of Interleukin-1 alpha in Risk for Heart Attacks xbiotech.com ↗
Dr. Libby’s team discovered that white blood cells, known as neutrophils, can release IL-1⍺ that could possibly lead to life threatening strokes in patients with heart disease, which offers the potential for new treatment approaches involving XBiotech’s anti-IL-1⍺ antibody, bermekimab. |
| 2018-01-26 | XBiotech, Inc. | Results XBiotech Announces Presentation of Data from Phase 2 Study Evaluating MABp1 for the Treatment of Hidradenitis Suppurativa xbiotech.com ↗
At least 30% decrease of the iHS4 score from the baseline at week 12 was associated with 100% sensitivity for positive HiSCR score (the efficacy measure |
| 2018-01-19 | XBiotech, Inc. | Results XBiotech Announces Presentation of Phase 2 Open Label Extension Study Data Evaluating MABp1 for the Treatment of Hidradenitis Suppurativa xbiotech.com ↗
During the OLE, five patients (5 of 7, or 71.4%) achieved the HiSCR response (p=0.035). |
| 2017-12-04 | XBiotech, Inc. | Results XBiotech Announces Publication of Phase 2 Data from Hidradenitis Suppurativa Phase 2 Study in The Journal of Investigative Dermatology xbiotech.com ↗
The results have been published online as an article in press in the prestigious, peer-reviewed Journal of Investigative Dermatology in a manuscript titled, “ MABp1 Targeting Interleukin-1alpha for Moderate to Severe Hidradenitis Suppurativa not Eligible for Adalimumab: A Randomized Study.” |
| 2017-11-14 | XBiotech, Inc. | Results XBiotech Announces Presentation of Novel Findings for MABp1 in the Prevention of Coronary Thrombosis at the American Heart Association Scientific Sessions xbiotech.com ↗
We have demonstrated that MABp1, an anti-IL-1⍺ antibody, can block induction of key molecules in vascular endothelial cells that can promote erosion-associated thrombosis. |
| 2017-06-01 | XBiotech, Inc. | Results XBiotech Presents Phase III Findings for its Antibody Therapy for Colorectal Cancer at the 2017 ASCO Meeting xbiotech.com ↗
For these per protocol patients, 40% of patients that received treatment with the antibody therapy achieved the primary endpoint, nearly double compared to placebo (40% vs 23%, relative risk 1.76, 95% CI 1.14 to 2.72, one-tailed p=0.003). |
| 2017-05-30 | XBiotech, Inc. | Results Dr. Razelle Kurzrock to Present Novel Biomarker Findings from XBiotech Phase III Colorectal Cancer Study Data at the 19th European Society for Medical Oncology World Congress on Gastrointestinal Cancer xbiotech.com ↗
These findings indicate a significant association between pre-treatment circulating levels of IL-1Ra and responsiveness to MABp1 therapy. |
| 2017-02-16 | XBiotech, Inc. | Results XBiotech Meets Primary Endpoint in Phase 2 Study of MABp1 for Treatment of Hidradenitis Suppurativa (HS) xbiotech.com ↗
The study met its primary endpoint, demonstrating significant improvement of HS patients compared to control after 12 weeks of therapy (Response rate of 60% vs 10%, respectively (p=0.035)). |
| 2017-01-17 | XBiotech, Inc. | Results XBiotech Phase 3 Data for Colorectal Cancer Therapy is Published in The Lancet Oncology xbiotech.com ↗
XBiotech Inc. (NASDAQ:XBIT) today announced the publication of results from its pivotal phase 3 trial of the Company’s lead monoclonal antibody therapy. |
| 2016-07-02 | XBiotech, Inc. | Results XBiotech Presents Pivotal Phase III Data Showing Xilonix(TM) Demonstrated Significant Clinical Response in Advanced Colorectal Cancer Patients Refractory to Further Treatment xbiotech.com ↗
XBiotech Inc. (NASDAQ:XBIT), developer of next-generation True Human(TM) antibody therapies, today presented positive results from a pivotal Phase III trial of Xilonix(TM), the company's lead monoclonal (IgG1k) antibody immunotherapy for the treatment of advanced colorectal cancer (CRC). |
| 2015-10-02 | XBiotech, Inc. | Results XBiotech Announces Publication of Clinical Results Supporting the Potential of Its True Human(TM) Antibody as a Cardiovascular Therapy xbiotech.com ↗
In the article titled, "A Randomized Phase II Study of Xilonix, a Targeted Therapy Against Interleukin 1 alpha, for the Prevention of Superficial Femoral Artery Restenosis After Percutaneous Revascularization," XBiotech reported that researchers observed tendencies toward improved vessel patency and fewer major adverse cardiovascular events following dosing of MABp1 over a 3-month period. |
| 2015-07-07 | XBiotech, Inc. | Results XBiotech Announces Publication of Clinical Results Supporting Its True Human(TM) Antibody Therapy for Type 2 Diabetes Mellitus xbiotech.com ↗ |
| 2015-06-15 | XBiotech, Inc. | Results XBiotech Announces Publication of Phase 2 Clinical Results for Its True Human(TM) Antibody MABp1 for Treating Acne Vulgaris xbiotech.com ↗
XBiotech (Nasdaq:XBIT), the developer of True Human™ therapeutic antibodies, announces positive results from the Company's Phase 2 study of its MABp1 antibody for treating acne vulgaris. |
| 2015-06-15 | XBiotech, Inc. | Results CORRECTING and REPLACING -- XBiotech Announces Publication of Phase 2 Clinical Results for Its True Human(TM) Antibody MABp1 for Treating Acne Vulgaris xbiotech.com ↗
XBiotech (Nasdaq:XBIT), the developer of True Human™ therapeutic antibodies, announces positive results from the Company's Phase 2 study of its MABp1 antibody for treating acne vulgaris. |
| 2015-03-04 | XBiotech, Inc. | Results XBiotech Announces Phase II Psoriasis Study Results in JAMA Dermatology xbiotech.com ↗
XBiotech announced today that results from its Phase II pilot study in patients with moderate to severe plaque psoriasis have been published in JAMA Dermatology. |
All press releases naming this drug 28 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 21 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | bermekimab | “Phase I trial of Bermekimab with nanoliposomal irinotecan and 5-fluorouracil/folinic acid in advanced pancreatic ductal adenocarcinoma.” PMID 36056179 ↗ Sep 2022 |
| Known as | CA-18C3 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01260545 ↗ |
| Known as | CV-18C3 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01270945 ↗ |
| Known as | MABp1 | “Bermekimab (MABp1) is a first-in-class true human monoclonal antibody cloned directly from human B lymphocytes that specifically targets and neutralizes IL-1α.” NCT04045743 ↗4“A Phase II Study of Bermekimab (MABp1) in Patients With Moderate to Severe Atopic Dermatitis” NCT03496974 ↗ |
| Known as | RA-18C3 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01384630 ↗ |
| Known as | T2-18C3 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01427699 ↗ |
| Known as | Xilonix | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01767857 ↗ |
| Action | Inhibit | “We aimed to assess the safety and tolerability of MABp1 for interleukin-1α blockade in a refractory cancer population.” PMID 24746841 ↗ Apr 2014 |
| Modality | Monoclonal antibody | “We used a first-in-class, monoclonal antibody (MABp1) cloned from a human being to target interleukin-1α” PMID 24746841 ↗ Apr 2014 |
| Route | Intravenous | “Patients received MABp1 intravenously once every 3 weeks” PMID 24746841 ↗ Apr 2014 |
| Target | IL1A | “MABp1, a first-in-class true human antibody targeting interleukin-1α in refractory cancers” PMID 24746841 ↗ Apr 2014 |