UK-based biopharmaceutical firm Mereo BioPharma has commenced the Phase IIb ASTEROID clinical trial of BPS-804 to treat patients with osteogenesis imperfecta (OI).
BPS-804 is a fully humanised monoclonal antibody with the ability to enhance bone formation and minimise bone resorption, resulting in bone strengthening.
The product targets a protein called sclerostin, which prevents the bone-forming cell activity.
The randomised, double-blind, placebo-controlled, multi-centre Phase IIb trial is being conducted in the US and Europe, and will enrol a total of approximately 120 adult patients.
Mereo BioPharma chief executive officer Dr Denise Scots-Knight said: "The initiation of this potentially pivotal trial is an important milestone in the development of BPS-804.
"Osteogenesis imperfecta is a serious, debilitating and painful disease, for which there are currently no approved treatments that address the underlying bone weakness.
"We believe BPS-804’s mechanism of action is specifically suited to OI and has the potential to become a novel treatment option that could reduce fractures and improve the quality of life of these patients."
The primary endpoint of the trial is the change in trabecular volumetric bone mineral density, measured using high-resolution peripheral quantitative CT (HRpQCT) and bone strength change on finite element analysis (FEA).
The trail will also measure bone parameters on HRpQCT, bone turnover markers and quality-of-life scores.
While the top-line results from the ASTEROID trial are expected by next mid-year, Mereo intends to further evaluate BPS-804 in the second half of this year in paediatric patients with OI.