Mereo BioPharma’s Brittle Bone Disease Drug Accepted for EMA’s Adaptive Pathways Program

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BPS-804, which is being developed for the treatment of osteogenesis imperfecta (brittle bone disease), has been granted orphan drug designation by both FDA and the European Commission.

Clinical-stage biopharma company, Mereo BioPharma, announced on Feb. 20, 2017 that its brittle bone disease drug, BPS-804 has been accepted for EMA’s adaptive pathways program. The adaptive pathways approach is part of EMA’s efforts to improve timely access for patients to new medicines, primarily in areas of high medical need.  

BPS-804, which is being developed for the treatment of osteogenesis imperfecta (brittle bone disease), has been granted orphan drug designation by both FDA and the European Commission. There are currently no EMA or FDA approved treatments for osteogenesis imperfecta, a rare genetic disorder, characterized by fragile bones that break easily.

BPS-804 works by inhibiting sclerostin, which itself inhibits the activity of bone-forming cells, known as osteoblasts. It is believed that by blocking sclerostin, BPS-804 will induce or increase osteoblast function and maturation, increasing bone formation and reducing bone resorption, thereby reducing bone fragility and fractures in patients with osteogenesis imperfecta.

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Source: Mereo BioPharma