Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GP2411 · 1 trial · 1 indication
Bone density measurements were performed by dual energy X-ray absorptiometry (DXA). Lumbar spine scan included L1 through L4 vertebrae. All DXA scans were submitted to a central imaging vendor for analysis. A mixed effect model for repeated measurements (MMRM) was fitted to the changes from baseline in LS-BMD for all post-baseline time points up to Week 52. Values at Week 52 were estimated from the model and are presented in the table.
Bone density measurements were performed by DXA. Lumbar spine scan included L1 through L4 vertebrae. All DXA scans were submitted to a central imaging vendor for analysis. A MMRM was fitted to the changes from baseline in LS-BMD for all post-baseline time points up to Week 52. Missing values were assumed to be missing at random (MAR) using the MMRM model. Values at Week 52 were estimated from the model and are presented in the table.
Carboxy-terminal crosslinked telopeptides of type I collagen (CTX) is a bone resorption biomarker. Serum CTX concentration-time data were analyzed by non-compartmental methods. The AUEC of baseline corrected serum CTX concentrations (% change from baseline) was calculated using the linear trapezoidal method. Values below the lower limit of quantification (LLOQ) were imputed with the actual value for the LLOQ.
Serum denosumab concentration-time data were analyzed by non-compartmental methods. Missing denosumab serum concentrations or concentrations below the LLOQ were not imputed and handled as missing values, except for the pre-dose sample which were treated as zero.
Serum denosumab concentration-time data were analyzed by non-compartmental methods. Missing denosumab serum concentrations or concentrations below the LLOQ were not imputed and handled as missing values, except for the pre-dose sample which were treated as zero. The linear-up log-down trapezoidal method was used for the AUCinf calculation.
| Arm | Type | Description |
|---|---|---|
| GP2411 | EXPERIMENTAL | 60 mg /mL subcutaneous injection every 6 months |
| EU authorized Prolia | ACTIVE_COMPARATOR | 60 mg /mL subcutaneous injection every 6 months |
| Name | Type | Description |
|---|---|---|
| GP2411 | BIOLOGICAL | 60 mg /mL subcutaneous injection every 6 months |
| EU-Prolia (EU-authorized Prolia®) | BIOLOGICAL | 60 mg /mL subcutaneous injection every 6 months |
Inclusion Criteria: * Postmenopausal women, diagnosed with osteoporosis * Aged ≥ 55 and ≤ 80 years at screening * Body weight ≥ 50 kg and ≤ 90 kg at screening * Absolute bone mineral density consistent with T-score ≤ -2.5 and ≥ -4.0 at the lumbar spine as measured by DXA * At least two vertebrae in...
GP2411 is an investigational monoclonal antibody being studied for the treatment of postmenopausal women with osteoporosis. It is being developed as a biosimilar to denosumab and is intended to address bone loss in this patient population.
GP2411 is a monoclonal antibody biosimilar to denosumab, which targets RANKL, a protein involved in bone resorption. By inhibiting RANKL, GP2411 aims to reduce bone loss and improve bone density in postmenopausal women with osteoporosis.
GP2411 is being developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. Novartis is conducting clinical trials to evaluate the safety and efficacy of GP2411 in patients with osteoporosis.
GP2411 is in Phase 3 clinical development. A Phase 3 trial has been completed, evaluating the pharmacokinetics, pharmacodynamics, efficacy, safety, and immunogenicity of GP2411 in postmenopausal women with osteoporosis. The drug is still investigational and not yet approved.
GP2411 has one completed Phase 3 clinical trial, identified as NCT03974100. This study enrolled 527 postmenopausal women with osteoporosis across the United States, Bulgaria, Czechia, Japan, Poland, and Spain. The trial was randomized, double-blind, and active-controlled.
GP2411 is a biosimilar to denosumab, meaning it is designed to be highly similar to the reference biologic denosumab. While it is not the identical product, it is intended to have comparable efficacy, safety, and immunogenicity for treating postmenopausal osteoporosis.