Bermekimab[1] (MABp1, trade name Xilonix) is a human monoclonal antibody of IgG1k isotype targeting Interleukin 1 alpha (IL1A).[2]
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Human |
| Target | IL1A |
| Clinical data | |
| Trade names | Xilonix |
| Other names | MABp1 |
| Routes of administration | intravenous |
| ATC code | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| ChemSpider |
|
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6464H10024N1736O2000S44 |
| Molar mass | 145468.09 g·mol−1 |
Bermekimab was developed by XBiotech Inc.[3]
After Phase III trials in Poland failed to show significant improvement in either lean body mass or quality of life, the European Medicines Agency (EMA) rejected the drug application[4].
The company Janssen Pharmaceutical acquired the license for the drug from XBiotech[5] for the treatment of atopic dermatitis and hidradenitis suppurativa for $750 million.
As of June 2021[update], bermekimab was also terminated in phase III clinical trials as an immunotherapy for advanced colorectal cancer[6]. The original aim was to treat the debilitating symptoms seen in patients with advanced colorectal cancer, such as muscle wasting. The study was terminated as it had crossed the prospective futility boundary of primary endpoint.
As of March 2021[update] an additional phase II clinical trial for the treatment of atopic dermatitis was completed[7]. Janessen and Johnson & Johnson announced was ending development of bermekimab in eczema but said it will continue to work on the previously rejected XBiotech drug in hidradenitis suppurativa (HS). The move resulted in a $610 million pretax impairment charge[8].
References
edit- ^ Statement On A Nonproprietary Name Adopted By The USAN Council - Bermekimab, American Medical Association.
- ^ Hong DS, Hui D, Bruera E, Janku F, Naing A, Falchook GS, et al. (May 2014). "MABp1, a first-in-class true human antibody targeting interleukin-1α in refractory cancers: an open-label, phase 1 dose-escalation and expansion study". The Lancet. Oncology. 15 (6): 656–66. doi:10.1016/S1470-2045(14)70155-X. PMID 24746841.
- ^ "Xilonix True Human monoclonal antibody by Xbiotech oncology". www.xbiotech.com. XBiotech. Retrieved 3 March 2017.
- ^ https://www.fiercebiotech.com/biotech/xbiotech-s-worst-fears-come-true-as-ema-rejects-colorectal-cancer-drug
- ^ https://www.jnj.com/media-center/press-releases/janssen-to-acquire-investigational-bermekimab-from-xbiotech
- ^ Clinical trial number NCT01767857 for "A Phase III Study of Xilonix in Patients With Advanced Colorectal Cancer (XCITE)" at ClinicalTrials.gov
- ^ Clinical trial number NCT03496974 for "A Phase II Study of Bermekimab (MABp1) in Patients With Moderate to Severe Atopic Dermatitis" at ClinicalTrials.gov
- ^ https://www.fiercebiotech.com/biotech/j-j-discontinues-work-eczema-drug-leading-to-610m-impairment-charges-for-ex-xbiotech-asset
