LONDON (Alliance News) - Mereo Biopharma Group PLC on Monday said it has completed patient enrolment in its phase 2b clinical study of its drug BPS-804, or Setrusumab, which is being conducted in the US and in Europe.
The Setrusumab trial will assess the drug's ability to treat the orphan genetic disorder osteogenesis imperfecta, most commonly known as brittle bone disease. The disease causes fragile bones that break easily, as well as causing weakened teeth and loose joints.
In total, 112 adult patients have been enrolled in the trial with six-month data on the top dose expected in the first half of 2019 and twelve-month data in the second half. Top-line 12-month data is expected in the fourth 2019 quarter.
Setrusumab has orphan drug designation, there being no approved US Food & Drug Administration or European Medicines Agency treatments for brittle bone disease.
A paediatric investigation plan was approved by the EMA in August and intends to enrol 160 children with severe disease, aged between five and 18 years, in a 2019 trial.
"We believe BPS-804's mechanism of action is specifically suited to osteogenesis imperfecta and has the potential to become a novel treatment option that could reduce fractures and improve quality of life of these patients. We look forward to announcing data from this study during the course of 2019," said Mereo Chief Medical Officer Alastair Mackinnon.
Shares in Mereo were untraded on Monday, having last closed at 226.00 pence on Friday.