Shanghai Henlius Biotech Inc. (HKG: 2696), based in China, has announced that its global, multi-center Phase III clinical trial for HLX14, a biosimilar of Amgen’s Prolia/Xgeva (denosumab), has successfully met its primary endpoints in treating postmenopausal osteoporosis in women at high risk of fracture.
The Phase III study aims to assess the efficacy, safety, tolerability, and immunogenicity of HLX14 compared to the originator drug among postmenopausal women at elevated fracture risk. Primary endpoints include the change in lumbar spine bone density (BMD) from baseline to week 52, as evaluated by central imaging, and the percentage change in serum collagen C-terminal peptide (s-CTX) from baseline to week 26, measured as the area under the time curve (AUEC0-26W). Secondary endpoints encompass additional efficacy evaluations, pharmacodynamic characteristics, incidence of concomitant events, safety, pharmacokinetic profiles, and immunogenicity.- Flcube.com
