EMA grants PRIME designation for Mereo’s BPS-804 to treat osteogenesis imperfecta

OI is a debilitating disease for which there is no current treatment approved by the U.S. Food and Drug Administration (FDA) or the EMA. Mereo announced commencement of a Phase 2b trial for BPS-804 in adult patients with OI in May 2017.

The EMA PRIME programme provides early collaborative input to clinical development including scientific advice and health-technology-assessment in order to facilitate rapid access for patients to novel drugs in areas of high unmet medical need once they are approved.

Since its inception in 2016, only 31 of 137 requests for PRIME have been granted. Under the PRIME programme, a marketing authorisation application (MAA) in Europe for BPS-804 for OI could be eligible for an accelerated regulatory assessment (150 days instead of 210 days).

As previously announced, BPS-804 for OI has also been accepted into the EMA's Adaptive Pathways Programme and has been granted orphan drug status in both the US and EU. 

BPS-804 is a fully humanised monoclonal antibody that inhibits sclerostin, a protein which inhibits the activity of bone-forming cells.

The mechanism of action of BPS-804 could be particularly well suited for the treatment of OI and has the potential to become a novel treatment that could reduce fractures and improve patient quality of life.

Dr Denise Scots-Knight, Chief Executive Officer of Mereo BioPharma Group commented: "We are delighted that the EMA has awarded BPS-804 a PRIME designation for OI. We believe this is further recognition that OI is a disease with a high unmet medical need and that BPS-804 has the potential to provide a much needed novel treatment option for these patients.

“We look forward to collaborating closely with the EMA through both PRIME and the Adaptive Pathways Programme to expedite the development of BPS-804 and potentially accelerate availability of this therapy for patients."