Clinical Trials

Date: 2018-10-15

Type of information: Results

phase: 2b

Announcement: completion of patient enrollment

Company: Mereo Biopharma (UK)

Product: BPS-804 (setrusumab)

Action mechanism:

  • monoclonal antibody. BPS-804 (setrusumab) is a human monoclonal antibody targeting sclerostin, which is being developed to improve bone strength and thereby reduce fractures in the orphan disease osteogenesis imperfecta (OI).
  • BPS-804  has been granted Orphan Drug Designation by the US FDA and the EMA. BPS-804 has also been accepted into the EMA‘s Adaptive Pathways Programme and granted PRIority MEdicines (PRIME) designation.

Disease: osteogenesis imperfecta (OI)

Therapeutic area: Bone diseases - Metabolic diseases - Rare diseases

Country: Canada, Denmark, France, UK, USA

Trial details:

  • The ASTEROID study aims  to select a suitable dose of BPS804 by comparing it with a dummy treatment and measuring the strength/quality of bone using a special type of CT scanner. Participants will be treated for 1 year.
  • The trial is expected to enrol up to 120 adult OI patients and is a randomised, double-blind, placebo-controlled, multi-centre study which is being conducted in the US and Europe.
  • The study’s primary endpoint is change from baseline of Bone Mineral Density (BMD) after 12 months as measured by High Resolution peripheral Quantitative Computed Tomography (HR-pQCT) and the secondary endpoints of BMD using traditional two-dimensional dual-energy X-ray absorptiometry (DXA) measurement together with measurement of serum bone biomarkers. Bone microarchitecture assessed by HRpQCT has been shown to be a predictor of fracture risk in postmenopausal women (The OFLEY study1 ). In a previous study in OI patients, BPS804 showed a statistically significant improvement in BMD and on bone biomarkers.(NCT03118570)

Latest news:

  • • On October 15, 2018, Mereo BioPharma announced it has successfully completed patient enrolment in the potentially pivotal adult phase 2b ASTEROID clinical study of BPS-804 (setrusumab) for the treatment of osteogenesis imperfecta , an orphan genetic disorder known as brittle bone disease.
  • A total of 112 adult patients have been enrolled into this multi-centre, randomised, double-blind, dose-finding study, which is being conducted in the US and Europe. The study has 4 arms and includes an open-label arm which is expected to report six-month data on the top dose in H1 2019 and 12-month data in H2 2019. Top-line 12 month data from the blinded dose ranging part of the study is expected in Q4 2019.
  • In August 2018, the company’s Paediatric Investigation Plan (PIP) was approved by the European Medicine Agency. Mereo plans to commence this registration trial in approximately 160 children with severe disease aged 5-18 years old in 2019. The primary endpoint will be fracture rate over a 12-month period.    
  • • On May 4,2017, Mereo BioPharma announcedt the initiation of  the ASTEROID study. This potentially pivotal Phase 2b clinical study is evaluating BPS-804 for the treatment of the orphan disease, osteogenesis imperfecta (brittle bone disease). Top-line results for the ASTEROID study are expected in mid-2018.Clinical studies in 83 patients to date have shown that BPS-804 is safe and well tolerated. In a study in OI patients BPS-804 showed a statistically significant improvement in bone mineral density and on bone biomarkers.
  • Mereo intends to begin a further study in paediatric OI patients in H2 2017.

Is general: Yes