Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BHV-1400 · 2 trials · 1 indication
To assess the safety and tolerability of BHV-1400. This objective will be measured by assessing the number of unique subjects with SAEs, moderate or severe AEs, AEs leading to discontinuation or deaths
To assess the safety and tolerability of BHV-1400. This objective will be measured by assessing the number of unique subjects with Grade 3 or 4 treatment-emergent laboratory abnormalities.
| Arm | Type | Description |
|---|---|---|
| BHV-1400 | EXPERIMENTAL | 500mg BHV-1400 is delivered subcutaneously via autoinjector. Participants will be randomized in a 2:1 ratio to receive either BHV-1400 or placebo. |
| Placebo | PLACEBO_COMPARATOR | Matching placebo is delivered subcutaneously via autoinjector. Participants will be randomized in a 2:1 ratio to receive either BHV-1400 or placebo. |
| Name | Type | Description |
|---|---|---|
| BHV-1400 | DRUG | 500 mg delivered subcutaneously via autoinjector |
| Placebo | DRUG | Matching placebo delivered subcutaneously via autoinjector |
Key Inclusion Criteria: * Diagnosis of IgAN as confirmed by renal biopsy conducted within 10 years prior to Screening. * If a participant has a history of diabetes, the biopsy must have been conducted within 2 years prior to Screening with no evidence of diabetic nephropathy. * In all cases, i...
| 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 |