Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1414 |
| INN | Setrusumab |
| Status | Clinical |
| Drug code(s) | UX143, BPS804, MOR05813 |
| Brand name | None |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG2 |
| Light chain isotype | lambda |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Phage display (HuCAL)-derived antibody |
| Target(s) | Sclerostin |
| Indications of clinical studies | Osteogenesis imperfecta, hypophosphatasia, low bone mineral density |
| Primary therapeutic area | Skeletal disorders |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | January 01, 2008 |
| Start of Phase 2 | June 15, 2011 |
| Start of Phase 3 | February 21, 2022 |
| 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 | Mereo BioPharma Group plc |
| Licensee/Partner | Ultragenyx Pharmaceutical Inc. |
| Comments about company or candidate | NCT06636071 Phase 3 in OI due to start in Oct 2024. Phase 2/3 and Phase 3 studies for Osteogenesis imperfecta NCT05125809 and NCT05768854 are recruiting as of May-June 2023 Apr 20, 2022: Ultragenyx Pharmaceutical Inc. announced the first patient has been dosed in a clinical study for the treatment of Osteogenesis Imperfecta (OI) in patients ages 5 to <26 years of age. The pivotal Orbit study is a seamless Phase 2/3 study of setrusumab (UX143), an investigational anti-sclerostin fully human monoclonal antibody in development for the treatment of OI in children and adults with OI sub-types I, III and IV. Ultragenyx is leading the clinical development of setrusumab as part of a collaboration and license agreement with Mereo BioPharma Group plc (MREO), a clinical-stage biopharmaceutical company focused on oncology and rare diseases. NCT05125809 Phase 2/3 in Osteogenesis Imperfecta due to start in Dec 2021. Dec 2020: Under the terms of the collaboration, Ultragenyx will lead future global development of setrusumab in both pediatric and adult patients. Mereo granted Ultragenyx an exclusive license to develop and commercialize setrusumab in the US and rest of the world, excluding Europe where Mereo retains commercial rights. Each party will be responsible for post-marketing commitments in their respective territories. Sep 2020: Mereo BioPharma announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease designation to setrusumab for the treatment of osteogenesis imperfecta (OI). June 2020: Mereo intends to complete a strategic partnership for setrusumab for the treatment of osteogenesis imperfecta (“OI”) prior to initiation of the pivotal Phase 3 study. Feb 28, 2020: Mereo BioPharma announced the completion of a Type B End-of-Phase II meeting with the U.S. Food and Drug Administration (FDA) to discuss the development of setrusumab, an anti-sclerostin antibody, for the treatment of children and adolescents with osteogenesis imperfecta (OI). Following the review of the data from the Company’s Phase IIb ASTEROID study with setrusumab in adults with OI, the FDA agreed on the design of a Phase III pediatric study in OI to be completed prior to the submission of a Biologics License Application (BLA) in the United States. This is in line with Mereo’s proposed pivotal pediatric study design that has already been agreed to in principle with the European Medicines Agency (EMA). Jan 2020: FDA Type B End-of-Phase 2 Meeting Scheduled for Q1 2020. Pediatric Phase 3 study design accepted by EMA. NCT03118570 Phase 2 study in Osteogenesis imperfecta started in Sep 2017; Company intends to initiate a potential registration trial of BPS-804 in the second half of 2016. Nov 2017: Granted EMA PRIME designation. Potentially pivotal Phase 2b clinical study of BPS-804 for the treatment of the orphan disease, osteogenesis imperfecta (OI) (brittle bone disease), the ASTEROID study, started in May 2017. Company intends to initiate a Phase 2/3 trial of BPS-804 in H1 2017. Mereo will develop the mab for osteogenesis imperfecta, an orphan indication in US and EU. NCT01406977 Phase 2 Dose Escalation Study to Evaluate the Safety and Tolerability of Multiple Infusions of BPS804 in Adults With Hypophosphatasia started in July 2011. NCT01417091 started in June 2011; results published in March 2017 (https://asbmr.onlinelibrary.wiley.com/doi/10.1002/jbmr.3143). Date of first phase 1 is estimated. Derived from MorphoSys HuCAL library. BPS-804 has been granted Orphan Drug Designation by the US FDA and the EMA. |
| Full address of company | 4th Floor, 1 Cavendish Place, London, W1G 0QF, United Kingdom Europe United Kingdom https://www.mereobiopharma.com/contact-us/# |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |