These additional prespecified endpoint data build upon the Company's 12-month topline data from the ASTEROID study announced in
'Based upon our review of the comprehensive data set from the Phase 2b ASTEROID study, these additional prespecified analyses support our previous conclusions that setrusumab is building bone at the lumbar spine and is increasing bone strength at multiple peripheral sites in adult OI patients,' said Dr.
'Finite element analysis ('FEA') is one of the best measures available to monitor bone strength in clinical studies, being sensitive to important changes in trabecular and cortical bone as well as overall bone structure. In OI patients given setrusumab for 12 months, the FEA technique was used to assess forearm (radius) bone strength at the beginning and end of the treatment period,' said Dr.
ABOUT THE PHASE 2B ASTEROID STUDY
ASTEROID was a 12-month, randomized, double-blind, Phase 2b dose-finding study in 112 adults diagnosed with type I, III or IV Osteogenesis Imperfecta and a confirmed COL1A1/COL1A2 mutation who have fractured over the previous 5 years. ASTEROID was the largest, prospectively-designed, interventional clinical study to be performed in this patient group. The primary endpoint of the study was the change over baseline in Tr vBMD of the wrist at 12 months, followed by bone strength measured by Finite Element Analysts (hierarchical) assessed using HR-pQCT. Change from baseline at 6 and 12 months for areal BMD at the lumbar spine, as measured by DXA, was an important secondary endpoint. Additional secondary endpoints included HR-pQCT parameters (such as total vBMD), bone biomarkers, patient reported outcomes (PRO) and quality of life measures. Fracture data were also collected throughout the duration of the study, although the trial was not statistically powered for fractures.
ABOUT OSTEOGENESIS IMPERFECTA
Osteogenesis Imperfects (OI) is a rare genetic disorder that is characterized by fragile bones and reduced bone mass resulting in bones that break easily, loose joints and weakened teeth. In severe cases patients may experience hundreds of fractures in a lifetime. In addition, people with OI often suffer muscle weakness, early hearing loss, fatigue, curved bones, scoliosis, respiratory problems and short stature, leading to significant impacts on overall health and quality of life. The majority of cases of OI (estimated at approximately 90%) are caused by a dominant mutation in a gene coding for type I collagen, a key component of healthy bone. Current treatment of OI is supportive, focusing on minimizing fractures and maximizing mobility, but to date, there are no EMA or FDA approved treatments.
ABOUT SETRUSUMAB
Setrusumab is a fully humanized monoclonal antibody that inhibits sclerostin, a protein which inhibits the activity of bone-forming cells. The mechanism of action of setrusumab could be particularly well suited for the treatment of OI and has the potential to become the first approved treatment option that could reduce fractures and improve OI patients' quality of life. In addition to evaluating setrusumab in adult OI patients, Mereo's Paediatric Investigation Plan (PIP) has been approved by the
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