Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AVT03 · 3 trials · 3 indications
Percent Change From Baseline in LS BMD at Month 12 to demonstrate comparable efficacy of AVT03 and Prolia®.
Samples will be collected for measurement
Samples will be collected for measurement
Venous blood samples will be collected for measurement of Area under serum concentration-time curve (AUC 0-t) AVT03 and Prolia
Venous blood samples will be collected for measurement of CTX-1 serum biomarker for AVT03 and Prolia.
Venous blood samples will be collected for measurement of maximum serum concentration (Cmax) of AVT03 and Prolia.
| Arm | Type | Description |
|---|---|---|
| AVT03 | EXPERIMENTAL | AVT03 is the proposed biosimilar for Prolia. |
| Prolia | ACTIVE_COMPARATOR | - |
| Experimental Arm AVT03 120mg | EXPERIMENTAL | AVT03 is the proposed biosimilar for Xgeva (denosumab). Subjects in this arm will receive a single 120mg dose of AVT03 as a subcutaneous injection |
| Active Comparator Xgeva 120mg | ACTIVE_COMPARATOR | Xgeva (denosumab) is the proposed active comparator for AVT03. Subjects in this arm will receive a single 120mg dose of Xgeva (denosumab) as a subcutaneous injection |
| AVT03 Arm | EXPERIMENTAL | AVT03 (denosumab) is the proposed biosimilar for Prolia (denosumab). Subjects in this arm will receive a single 60mg dose of AVT03 (denosumab) as a subcutaneous injection. |
| Prolia Arm | ACTIVE_COMPARATOR | Prolia(denosumab) is the proposed comparator for AVT03 (denosumab). Subjects in this arm will receive a single 60mg dose of Prolia (denosumab) as a subcutaneous injection. |
| Name | Type | Description |
|---|---|---|
| AVT03 | BIOLOGICAL | AVT03 (denosumab) is a recombinant fully human IgG2 monoclonal antibody to RANKL to be administered as a subcutaneous injection. Subjects in this arm received AVT03 60mg administered s.c. on Day 1 and at Month 6. At Month 12, subjects in the AVT03 arm received a third dose of AVT03 60 mg. |
| Denosumab | BIOLOGICAL | Prolia (denosumab) is a recombinant fully human IgG2 monoclonal antibody to RANKL developed to be administered as a subcutaneous injection. Subjects in this arm received 60mg of commercially available US-Prolia, administered s.c on Day 1 and at Month 6. At Month 12, subjects in the Prolia treatment group were re-randomized in a 1:1 ratio to receive either: * AVT03 60 mg administered s.c. on Day365. * Prolia 60 mg administered s.c. on Day365. |
| Prolia | BIOLOGICAL | Prolia (denosumab) will be given as single subcutaneous injection |
1. Postmenopausal women with osteoporosis willing to sign an informed consent form (ICF)and able to undergo protocol related procedures. 2. A baseline dual-energy x-ray absorptiometry (DXA) scan with a T score ≤-2.5 and * 4.0 at the LS (L1 to L4)and/or, total hip, and/or femoral neck. 3. Age: ≥5...
AVT03 is an investigational monoclonal antibody being developed for postmenopausal osteoporosis. It is also being studied in healthy male subjects in early-phase trials. The drug is not approved and remains in clinical development.
AVT03 is being developed by Alvotech, a biopharmaceutical company listed on the Nasdaq under the ticker ALVO.
AVT03 is in Phase 1 clinical development, with completed Phase 1 trials in healthy volunteers. A Phase 3 trial in postmenopausal women with osteoporosis has also been completed, but the drug remains investigational and is not FDA approved.
AVT03 has been studied in three completed trials: NCT05126784, a Phase 1 study in healthy male subjects; NCT05395091, a Phase 3 study in postmenopausal women with osteoporosis; and NCT05876949, a Phase 1 study in healthy male subjects.
AVT03 is being studied in comparison with Prolia and Xgeva in clinical trials, but it is a separate investigational drug. It is not the same as either Prolia or Xgeva.