During extended trading session, Mereo BioPharma Group plc (NASDAQ: MREO) observed a favorable trend in its share prices following the announcement of fresh results from orbit studies. MREO stock rose 13.37% to $3.99 on US stock charts, following a 1.44% increase to close at $3.52 during the regular session.
Positive Results From the Phase 2 Orbit Study
Mereo (MREO) announced positive 14-month results from the Phase 2 section of the ongoing Phase 2/3 Orbit study, which is being conducted in collaboration with Ultragenyx Pharmaceutical. Results showed that therapy with setrusumab substantially reduced the incidence of fractures in those with osteogenesis imperfecta (OI) after at least 14 months of follow-up.
Furthermore, by month 12, there had been significant and long-lasting gains in the lumbar spine bone mineral density (BMD) due to setrusumab therapy, with no symptoms of plateauing. The previously reported significant reduction in the annualized fracture rate for patients treated for a minimum of 6 months was maintained in those treated for at least 14 months.
Consistent Efficacy And Safety Profile
The results indicate that setrusumab is achieving the anticipated effects, safely decreasing fracture incidence and enhancing BMD in OI patients. The anti-sclerostin antibody remains effective even after a year, with patients continuing to show measurable gains, suggesting a prolonged response over the long term.
The consistent and significant improvements in BMD and Z-scores across all studied OI sub-types indicate that new, stronger bone is being formed, leading to a substantial reduction in fractures across different age groups and OI types.
Mereo BioPharma is eager to possibly provide this novel medication to more OI patients, since the Phase 3 Orbit and Cosmic investigations are now completely recruited. As of the data cut-off date, no treatment-related serious adverse events were observed.
The reported adverse events were in line with those seen in the Asteroid study, with infusion-related reactions and headaches being the most common. No hypersensitivity reactions to setrusumab were observed.
Mereo BioPharma’s ongoing commitment to improving outcomes for OI patients is reflected in these promising results, paving the way for further advancements in treatment options.
