British Biotech Gets PRIME Designation for its Brittle Bones Drug

Osteogenesis imperfecta Mereo EMA

The EMA has awarded PRIME Designation to Mereo BioPharma’s osteogenesis imperfecta drug, a condition for which there is no treatment on the market.

Mereo acquires, develops and commercializes therapies for patients with rare diseases. It was set up by Denise Scots-Knight, one of our top women entrepreneurs, in 2015 and already has a market cap of £230M (€260M). The company’s portfolio contains four clinical‑stage candidates, including BPS-804 for the treatment of osteogenesis imperfecta. The candidate has been given Prime Designation by the EMA, which means Mereo will receive scientific advice and health-technology-assessment to accelerate the approval of its candidate. The company has enjoyed a 16% increase in its share price over the last year.

BPS-804 is a human monoclonal antibody targeting sclerostin, which is a small protein involved in the regulation of bone remodelling through the inhibition of osteoblastic bone formation. The candidate aims to improve bone quality to reduce the frequency of fractures in osteogenesis imperfecta patients. Bone Therapeutics took its allogeneic bone cell therapy for osteoporosis into a Phase II trial, while researchers at the Karolinska Institutet tested transplanting stem cells into unborn babies.

Image – Crevis /

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