Mereo BioPharma Group plc, a UK-based biopharmaceutical company focused on the development of innovative medicines that aim to address unmet medical needs in rare and specialty disease areas and improve patient quality of life, has announced that BPS-804 has been accepted to participate in the European Medicines Agency’s (EMA) Adaptive Pathways programme. The adaptive pathways approach is part of the EMA’s efforts to improve timely access for patients to new medicines, primarily in areas of high medical need.

BPS-804 is being developed for the treatment of osteogenesis imperfecta (OI) (brittle bone disease). It has been granted orphan drug designation by both the European Commission (EC) and the US Food and Drug Administration (FDA).

Osteogenesis imperfecta is a rare genetic disorder that is characterized by fragile bones that break easily, for which there are currently no EMA or FDA approved treatments. BPS-804 works by inhibiting sclerostin, which itself inhibits the activity of bone-forming cells, known as osteoblasts. The Company believes 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 OI patients.

Dr Denise Scots-Knight, chief executive officer of Mereo BioPharma Group plc commented: “We are delighted that BPS-804 has been accepted on to the EMA’s Adaptive Pathways programme. Osteogenesis imperfecta is a serious, debilitating and painful disease where we believe BPS-804 could reduce fractures and improve quality of life in OI patients. We are on track to initiate a phase 2b trial for BPS-804 in H1 2017 and as part of the Adaptive Pathways we have the potential to bring this important therapy to patients sooner.”

The Adaptive Pathways approach is part of the European Medicines Agency’s efforts to improve timely access for patients to new medicines, primarily in areas of high medical need. Adaptive Pathways is a scientific concept for medicine development and data generation which allows for early and progressive patient access to a medicine.