Mereo BioPharma’s bone disease drug 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, a rare genetic disorder that is characterized by fragile bones that break easily, for which there are currently no EMA or FDA approved treatments.
The drug has been granted orphan drug designation by both the European Commission (EC) and the U.S. Food and Drug Administration (FDA).
Dr Denise Scots-Knight, Chief Executive Officer of Mereo BioPharma Group plc commented: “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.”