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Povetacicept · 6 trials · 11 indications
| Arm | Type | Description |
|---|---|---|
| Povetacicept | EXPERIMENTAL | Participants will be randomized to receive Povetacicept. |
| Placebo | PLACEBO_COMPARATOR | Participants will be randomized to receive placebo matched to Povetacicept. |
| Phase 2b: Povetacicept | EXPERIMENTAL | Participants will be randomized to receive one of the two doses of Povetacicept. |
| Phase 3: Povetacicept | EXPERIMENTAL | Participants will be randomized to receive one of the two doses of Povetacicept (dose selected based on Phase 2b). |
| Phase 3: Calcineurin Inhibitor (CNI) | ACTIVE_COMPARATOR | Participants will be randomized to receive the calcineurin inhibitor (CNI) Tacrolimus. |
| Part A1: Povetacicept Bioavailability | EXPERIMENTAL | Participants will be randomized to receive one of the two Povetacicept formulations. |
| Part A2: Povetacicept Bioavailability | EXPERIMENTAL | Participants will be randomized to receive one of the two Povetacicept formulations. |
| Part B1: Povetacicept Bioequivalence | EXPERIMENTAL | Participants will be randomized to receive one of the two Povetacicept presentations. |
| Part B2: Povetacicept Bioequivalence | EXPERIMENTAL | Participants will be randomized to receive one of the two Povetacicept presentations. |
| Part 1: Povetacicept 240mg | EXPERIMENTAL | Participants grouped in 3 cohorts by diagnosis will be administered Povetacicept |
| Part 2: Povetacicept Dose A | EXPERIMENTAL | Based on the findings of Part 1, one or two dose levels may be assessed in Part 2; if two dose levels are assessed participants will be randomized to receive one of the two dose levels of Povetacicept |
| Name | Type | Description |
|---|---|---|
| Povetacicept | DRUG | Subcutaneous injection administration. |
| Placebo (matched to Povetacicept) | DRUG | Placebo matched to Povetacicept subcutaneous injection administration. |
| Placebo | DRUG | Solution for Subcutaneous Injection. |
| Tacrolimus | DRUG | Capsules for Oral Administration. |
Key Inclusion Criteria: * Diagnosed IgAN, with biopsy confirmation * 24-hr proteinuria excretion ≥1.0 g/day or 24-hour uPCR ≥0.75 g/g * Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m\^2 * Stable angiotensin converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker (ARBs) ...
Povetacicept is an investigational drug being studied for autoantibody-associated glomerular diseases, including primary membranous nephropathy, immunoglobulin A nephropathy, and lupus nephritis. It is also being evaluated for generalized myasthenia gravis and immune thrombocytopenia. The drug is currently in clinical development and is not approved by the FDA.
Povetacicept is being developed by Vertex Pharmaceuticals Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker VRTX. Vertex is conducting clinical trials of Povetacicept across multiple countries, including the United States, Australia, and several European and Asian nations.
Povetacicept is in multiple phases of clinical development. It is in Phase 1 for healthy volunteers and for autoantibody-associated glomerular diseases, Phase 2 for primary membranous nephropathy, and Phase 3 for immunoglobulin A nephropathy. The drug remains investigational and has not received FDA approval.
Povetacicept is being studied in several clinical trials. NCT05732402 is a Phase 1 open-label study in autoantibody-associated glomerular diseases. NCT06564142 is a Phase 3 trial in immunoglobulin A nephropathy. NCT07010406 is a completed Phase 1 bioavailability study in healthy volunteers. NCT07204275 is a Phase 2 trial in primary membranous nephropathy.
Povetacicept is a small molecule that targets the BAFF and APRIL pathways, which are involved in B-cell activation and autoantibody production. By modulating these pathways, the drug aims to reduce the autoimmune response implicated in diseases such as immunoglobulin A nephropathy and lupus nephritis.