Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 35 |
| INN | Spesolimab |
| Status | Approved |
| Drug code(s) | BI 655130 |
| Brand name | SPEVIGO |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | IL-36R |
| Indications of clinical studies | Hidradenitis Suppurativa, Crohn's disease, palmoplantar pustulosis, Generalized pustular psoriasis, ulcerative colitis, atopic dermatitis |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Approved EU, US, Japan, Australia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | September 15, 2015 |
| Start of Phase 2 | April 15, 2017 |
| Start of Phase 3 | May 27, 2019 |
| Date BLA/NDA submitted to FDA | October 01, 2021 |
| Year of first approval (global) | 2022 |
| Date of first US approval | September 01, 2022 |
| INN, US product name | Spesolimab, spesolimab-sbzo |
| US or EU approved indications | Treatment of generalized pustular psoriasis flares in adults |
| Company | Boehringer Ingelheim |
| Licensee/Partner | LEO Pharma |
| Comments about company or candidate | Approved by EC on Dec 9, 2022. Sept. 1, 2022: Boehringer Ingelheim announced today the U.S. Food and Drug Administration has approved SPEVIGO, the first approved treatment option for generalized pustular psoriasis (GPP) flares in adults. SPEVIGO is a novel, selective antibody that blocks the activation of the interleukin-36 receptor (IL-36R), a key part of a signaling pathway within the immune system shown to be involved in the cause of GPP. June 2022: Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program for spesolimab in Crohn’s disease. NCT05013385 Phase 2 study in CD terminated (sponsor decision) as of last update on June 23, 2022. On December 15, 2021, Boehringer Ingelheim announced that the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for spesolimab for the treatment of generalized pustular psoriasis (GPP) flares. Spesolimab was granted US Orphan Drug Designation for the treatment of GPP, and Breakthrough Therapy Designation for the treatment of GPP flares in adults. October 29, 2021 I Boehringer Ingelheim announced today that the company’s marketing authorization application for the treatment of flares in generalized pustular psoriasis, has been validated and is now under evaluation with the European Medicines Agency. The marketing authorization application package includes results from the pivotal Effisayil-1 global trial Phase 2 in Hidradenitis Suppurativa due to start in July 2021. NCT04086121 Phase 2 study in atopic dermatitis not yet recruiting as of Sep 11, 2019. NCT03886246 Phase 3 study in pustular psoriasis started recruiting in May 2019. March 7, 2019: The New England Journal of Medicine (NEJM) today published new data from a Phase I clinical trial showing BI 655130, a first-in-class investigational treatment, significantly improved symptoms of generalised pustular psoriasis (GPP), a rare form of psoriasis. NCT03482635 Phase 2/3 study in UC started in March 2018. Three Phase 2 studies recruiting as of June 28, 2017. US orphan designation as a Treatment of generalized pustular psoriasis granted on Oct 3, 2018. NCT02525679 Phase 1 started in Sep 2015. |
| Full address of company | Binger Strasse 173 , 55216 Ingelheim am Rhein, Germany Europe Germany https://www.boehringer-ingelheim.com/contact-us |
According to IMGT, BI655130 is spesolimab, immunoglobulin G1-kappa, anti-[Homo sapiens IL1RL2 (interleukin 1 receptor like 2, interleukin 36 receptor, IL1R-rp2, IL1RRP2)], humanized monoclonal antibody. IgG1 antibody with Fc mutation for effector function knock-out, directed against human interleukin 1 receptor-like2 (IL-36R) (AAPS Nov 4-7, 2018)
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |