Henlius Reports the First Patient Dosing in P-III (HLX14-002-PMOP301) Trial of HLX14 (biosimilar, denosumab) to Treat Osteoporosis in Postmenopausal Women
Shots:
- The first patient has been dosed in P-III (HLX14-002-PMOP301) trial to evaluate HLX14 (SC) vs denosumab in a ratio (1:1) in postmenopausal women with osteoporosis at high risk of fracture
- The 1EPs of the study were the percentage change in BMD at the lumbar spine from baseline to Day 365. The 2EPs include the percentage change in BMD at the total hip from baseline to Day 365; femoral neck from baseline to Day 365; serum type I collagen C-telopeptide & serum procollagen type 1 N-telopeptide from baseline to Day 29/92/183/274/365 along with safety, PK & immunogenicity
- Denosumab has been approved globally for a range of indications i.e., osteoporosis, giant cell tumor of bone, skeletal-related events in patients with MM & bone metastases from solid tumors
Ref: Henlius | Image: Henlius
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