Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as VT-001
Atacicept · 4 trials · 9 indications
Percentage reduction in UPCR was obtained from geometric mean ratios. The natural log-transformed ratio of UPCR to its baseline value was analyzed using a Mixed Model for Repeated Measures (MMRM), adjusted by baseline variables specified in the Statistical Analysis Plan (SAP), including data from baseline up to Week 36 during the Double-Blind period.
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), study drug discontinuation due to TEAEs
Changes in proteinuria based on UPCR from 24 hour urine samples at baseline versus week 36
Gd-IgA1 levels through Week 24
Patient incidence of reported Adverse Events (AEs)
| Arm | Type | Description |
|---|---|---|
| Atacicept Dose 150mg | EXPERIMENTAL | Atacicept 150mg once weekly subcutaneous (SC) injections |
| Placebo to match Atacicept (Part C/D) | PLACEBO_COMPARATOR | Placebo to match Atacicept once weekly subcutaneous (SC) injection |
| IgAN or IgAVN | EXPERIMENTAL | Adult and pediatric patients with biopsy proven IgAN or IgAVN with varied severity of proteinuria and kidney function beyond what is currently included in most clinical trials. Adults with post-transplant IgAN recurrence are also included. |
| pMN | EXPERIMENTAL | Adults with biopsy-proven pMN associated with anti-PLA2R antibodies at low risk of spontaneous remission, or experiencing recurrent or resistant disease. |
| Primary Nephrotic Syndrome (MCD/FSGS) | EXPERIMENTAL | Adults with biopsy-proven primary MCD or FSGS and evidence of anti-nephrin antibodies. Children with frequently relapsing, steroid-dependent, or non-genetic steroid-resistant nephrotic syndrome with evidence of anti-nephrin antibodies. |
| Atacicept Arm 1 | EXPERIMENTAL | Atacicept dose A administered subcutaneous (sc) injection monthly |
| Atacicept Arm 2 | EXPERIMENTAL | Atacicept dose B administered subcutaneous (sc) injection monthly |
| Atacicept Arm 3 | EXPERIMENTAL | Atacicept dose C administered subcutaneous (sc) injection monthly |
| Atacicept Arm 4 | EXPERIMENTAL | Atacicept dose D administered subcutaneous (sc) injection weekly |
| Atacicept Arm 5 | EXPERIMENTAL | Atacicept dose E administered subcutaneous (sc) injection weekly for 24 weeks, followed by monthly sc injections |
| Atacicept 150mg once weekly subcutaneous (SC) injection | EXPERIMENTAL | Other Names: VT-001 |
| Name | Type | Description |
|---|---|---|
| Atacicept | BIOLOGICAL | Once weekly subcutaneous (SC) injections by prefilled syringe |
| Placebo to match Atacicept | OTHER | Once weekly subcutaneous (SC) injections by prefilled syringe |
| Atacicept 150 mg | DRUG | The atacicept drug product is available as a ready to use injection solution in the following prefilled syringe (PFS) that is composed of: \*BD Hypak™ SCF™ Barrel Glass barrel 1ml long with staked needle 27G ½" 5B with Rigid Needle Shield BD260 \*BD SCF™ Stopper 1ml long W4023 Flurotec |
Key Inclusion Criteria: * Must have the ability to understand and sign a written informed consent form * Male or female of ≥18 years of age * Total urine protein excretion ≥1.0 g per 24-hour or urine protein to creatinine ratio (UPCR) ≥1.0 mg/mg based on a 24-hour urine sample during the Screening ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 12 | PHASE3 | Zigakibart, Atrasentan, Iptacopan |
| Vera Therapeutics, Inc. Class A | VERA | 4 | PHASE3 | Atacicept |
| Vertex Pharmaceuticals Incorporated | VRTX | 4 | PHASE3 | Povetacicept, Sibeprenlimab |
| AstraZeneca PLC | AZN | 2 | PHASE3 | Ravulizumab |
| Biogen Inc. | BIIB | 2 | PHASE3 | Felzartamab |
| Biohaven Ltd. | BHVN | 2 | PHASE3 | BHV-1400 |
| Hoffmann-La Roche | RHHBY | 1 | PHASE3 | Sefaxersen |
| Travere Therapeutics, Inc. | TVTX | 1 | PHASE2 | Sparsentan |
| argenx SE Sponsored ADR | ARGX | 1 | PHASE2 | ARGX-121 |
| Q32 Bio Inc | QTTB | 1 | PHASE2 | ADX-097 |
| Jade Biosciences, Inc. | JBIO | 1 | PHASE2 | JADE101 |
Atacicept is an investigational therapy being developed for IgA Nephropathy (IgAN, also called Berger disease) and primary membranous nephropathy (pMN). It is also being studied in other glomerular diseases including nephrotic syndrome, minimal change disease (MCD), and focal segmental glomerulosclerosis (FSGS). It has not been approved by the FDA and remains in clinical development.
Atacicept targets TNFSF13B (also known as BAFF) and TNFSF13 (also known as APRIL). It is an inhibitor of these two cytokines, which are involved in B cell survival and antibody production. By blocking both TNFSF13B and TNFSF13, atacicept aims to reduce the production of pathogenic autoantibodies that drive IgA Nephropathy and other glomerular diseases.
Atacicept is being developed by Vera Therapeutics, Inc., which trades on the Nasdaq under the ticker VERA. Vera Therapeutics is the sponsor of the clinical trials evaluating atacicept in IgA Nephropathy and other glomerular diseases.
Atacicept is in Phase 3 clinical development. The Phase 3 trial NCT04716231 is evaluating atacicept in subjects with IgA Nephropathy and is currently active but not recruiting. Additional Phase 2 trials are ongoing in IgA Nephropathy and other glomerular diseases. Atacicept has not been approved by the FDA.
Atacicept is being studied in several clinical trials. These include the Phase 3 trial NCT04716231 in IgA Nephropathy, the Phase 2 trial NCT07020923 evaluating monthly dosing in IgAN, the Phase 2 trial NCT06983028 in multiple glomerular diseases including pMN, IgAN, nephrotic syndrome, MCD, and FSGS, and the Phase 2 rollover study NCT06674577 evaluating long-term safety and efficacy.