Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Atacicept · 4 trials · 9 indications
UPCR based on 24 hour urine collection
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 | 10 | PHASE3 | BION-1301 |
| Vera Therapeutics, Inc. Class A | VERA | 4 | PHASE3 | Atacicept |
| Travere Therapeutics, Inc. | TVTX | 2 | PHASE3 | sparsentan, irbesartan, Dapagliflozin |
| Biogen Inc. | BIIB | 1 | PHASE3 | Felzartamab |
| AstraZeneca PLC | AZN | 2 | PHASE3 | Ravulizumab |
| Vertex Pharmaceuticals Incorporated | VRTX | 2 | PHASE3 | Povetacicept |
| Biohaven Ltd. | BHVN | 1 | PHASE1 | BHV-1400 |
| Jade Biosciences, Inc. | JBIO | 1 | PHASE2 | JADE101 |
| Q32 Bio Inc | QTTB | 1 | PHASE2 | ADX-097 |