Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 2094 |
| INN | Otilimab |
| Status | Terminated |
| Drug code(s) | GSK3196165, MOR103, MOR-04357 |
| Brand name | None |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | lambda |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Phage display-derived (HuCAL library); Produced in PER.C6 cells |
| Target(s) | GM-CSF |
| Indications of clinical studies | COVID-19, Osteoarthritis, Rheumatoid Arthritis, Multiple Sclerosis |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Terminated at Phase 3 |
| Status | Inactive |
| Start of clinical phase (IND filing or first Phase 1) | December 15, 2007 |
| Start of Phase 2 | July 15, 2015 |
| Start of Phase 3 | May 16, 2019 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | MorphoSys AG |
| Licensee/Partner | GSK |
| Comments about company or candidate | Not listed in GSK pipeline dated Apr 26, 2023. Oct 2022: While the ContRAst-1 and ContRAst-2 trials met their primary endpoints, the efficacy demonstrated is unlikely to transform patient care for this difficult-to-treat patient population. Assessment of efficacy and safety data from the ContRAst programme is ongoing, however the limited efficacy demonstrated does not support a suitable benefit/risk profile for otilimab as a potential treatment for RA. As a result, GSK has decided not to progress with regulatory submissions. GSK H1 2022 report: Anticipated reg submission in 2023. MorphoSys Aug 2022 update: GSK expects a pivotal data readout of the phase 3 ContRAst program investigating otilimab for rheumatoid arthritis by the end of 2022. NCT04376684 is a Phase 2 study in COVID-19 patients. NCT04333147 Phase 3 in RA not yet recruiting when first posted on April 3, 2020. NCT04134728 Phase 3 in RA not yet recruiting as of Oct 22, 2019. NCT03980483 Phase 3 in RA started recruiting in May 2019. NCT03970837 Phase 3 study in RA started recruiting June 4, 2019. Oct 2018: Top-line data from GSK3196165’s Phase IIb BAROQUE trial included various secondary endpoints which produced statistically significant improvements, but the primary endpoint of the trial, DAS28(CRP)<2.6 at week 24, did not reach statistical significance. Aug 2018: Discontinued - Phase-II for Osteoarthritis in Germany, Netherlands, United Kingdom, Poland and USA. Total of 4 Phase 2 studies (3 in RA, 1 in OA) completed as of Jan 2018. NCT02504671 Phase 2 in RA recruiting as of Sep 2015. NCT01517282 Phase 1/2 recruiting as of Feb 2014. GSK in charge of development as of July 2014 |
| Full address of company | MorphoSys AG, Semmelweisstr. 7, 82152 Planegg, Germany Europe Germany https://www.morphosys.com/en/contact-us |
Immunoglobulin G1, anti-(human granulocyte-macrophage colony-stimulating factor) (human monoclonal GSK3196165 heavy chain), disulfide with human monoclonal GSK3196165 lambda-chain, dimer
| Anticipated events | None |
| Factor(s) contributing to discontinuation | Lack of efficacy |