āshibio has commenced subject dosing in the Phase Ib trial, ANDECA-HO, assessing the humanised antibody, andecaliximab, in spinal cord injury (SCI) patients at risk of developing heterotopic ossification (HO).
HO leads to abnormal bone formation in tendons, muscles, ligaments, and other soft tissues.
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The open-label trial is designed to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and safety of the antibody in up to ten adults aged between 18 and 89 years with a history of traumatic SCI.
This study marks an expansion of the antibody’s clinical development programme into non-hereditary heterotopic ossification (NHHO), a debilitating condition resulting from various forms of trauma, including SCI, hip arthroplasty, burns, and traumatic brain injury.
āshibio chief medical officer Deborah Wenkert said: “Heterotrophic ossification can prevent individuals with spinal cord injury from being in a sitting position, fitting into a wheelchair, or transferring from a bed.
“HO increases the risk of complications, such as bed sores and infections, and increases the SCI survivor’s reliance on others for activities of daily living, negatively impacting their quality of life.
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By GlobalData“Abnormal bone formation compresses nerves and blood vessels, leading to loss of function and poorer health outcomes. We hope the ANDECA-HO study brings us a step closer to delivering new options to patients living with or at risk of HO.”
It is the second trial for the antibody, following the first subject dosing in the Phase II/III study, ANDECAL, in January.
This study is designed to investigate the treatment of fibrodysplasia ossificans progressiva (FOP), a genetic condition causing severe HO from early childhood.
The common pathology of HO in both FOP and NHHO has led the company to explore andecaliximab’s potential in these conditions.
Andecaliximab targets the matrix metalloproteinase-9 (MMP9) enzyme, which is believed to promote HO in SCI patients due to its high expression in inflammatory areas.
Prior trials involving over 1,000 subjects have helped establish a tolerability and safety profile for the antibody.
