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Initiation of BPS-804 potentially pivotal Phase 2b study in patients with osteogenesis imperfecta, an orphan disease

05 May 17

Mereo BioPharma Group plc, a clinical stage, UK-based, biopharmaceutical company focused on rare and specialty diseases, announced today the initiation of the 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. 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.

 

Dr Denise Scots-Knight, Chief Executive Officer of Mereo BioPharma Group plc commented:

“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 quality of life of these patients. We look forward to announcing the top-line results for the ASTEROID study, which we expect in mid-2018.”

 

OI is a rare genetic disorder that is characterized by fragile bones that break easily. Current treatment of OI patients is largely surgical and focuses on reducing pain or addressing the complications associated with this disorder. BPS-804 is a fully humanised monoclonal antibody targeting sclerostin, a protein which itself prevents the activity of bone-forming cells. Treatment with BPS-804 increases bone formation and reduces bone resorption, thereby strengthening the bone and potentially reducing fractures in OI patients.

 

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.

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