Mereo BioPharma Group, a clinical stage, biopharmaceutical company focused on rare and specialty diseases, has initiated a 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.
OI is a rare genetic disorder that is characterized by fragile bones that break easily.
The FDA and EMA have granted the drug Orphan Drug Designation. Additional, EMA accepted it to its Adaptive Pathways Programme. Current treatment of the patients with OI is largely surgical and focuses on reducing pain or addressing the complications associated with this disorder.
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.”
Mereo said that it intends to begin a further study in paediatric OI patients in H2 2017.