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 |
BHV-1400 is an investigational small molecule being developed for the treatment of IgA Nephropathy, a kidney disease. It is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
BHV-1400 targets Gd-IgA1, a form of immunoglobulin A1 that is abnormally glycosylated and implicated in the pathogenesis of IgA Nephropathy. By targeting this molecule, BHV-1400 aims to address the underlying disease process.
BHV-1400 is being developed by Biohaven Ltd., a biopharmaceutical company. The company is conducting clinical trials to evaluate the safety and efficacy of BHV-1400 in patients with IgA Nephropathy.
BHV-1400 is in Phase 3 clinical development for IgA Nephropathy. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies and is still undergoing clinical trials to assess its effectiveness and safety.
BHV-1400 is being studied in two clinical trials. NCT07054684 is a Phase 1 study in IgA Nephropathy with 20 participants, recruiting in the United States and United Kingdom. NCT07642050 is a Phase 3 study with 420 participants, not yet recruiting, to determine if BHV-1400 is effective and safe in adults with IgA Nephropathy.