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BHV-1300 · 2 trials · 1 indication
To assess the safety and tolerability of BHV-1300. This objective will be measured by assessing the number of unique subjects with SAEs, AEs leading to discontinuation or deaths that are observed during the Open-label Treatment Phase (up to 52 weeks).
To assess the safety and tolerability of BHV-1300. 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-1300 | EXPERIMENTAL | BHV-1300 is delivered subcutaneously via autoinjector. Participants will be randomized in a 2:1 ratio to receive either BHV-1300 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-1300 or placebo. |
| Name | Type | Description |
|---|---|---|
| BHV-1300 | DRUG | delivered subcutaneously via autoinjector |
| Placebo | DRUG | delivered subcutaneously via autoinjector |
Key Inclusion Criteria: 1. Participants must have serologically confirmed Graves' disease as documented by presence of elevated autoantibodies 2. Participants must have active hyperthyroidism due to Graves' disease Key Exclusion Criteria: 1. History of hyperthyroidism not caused by Graves' Diseas...
BHV-1300 is an investigational small molecule being developed for the treatment of Graves Disease, an endocrine disorder. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities. The drug is being studied in adults aged 18 years and older.
BHV-1300 targets IgG, a class of proteins involved in the immune response. By targeting IgG, the drug aims to modulate the autoimmune processes underlying Graves Disease. This mechanism is being evaluated in clinical trials to assess its safety and efficacy in reducing disease activity.
BHV-1300 is developed by Biohaven Ltd., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol BHVN. The company is conducting clinical trials to evaluate the drug's potential as a treatment for Graves Disease.
BHV-1300 is in Phase 3 clinical development for Graves Disease. It is an investigational drug, meaning it has not yet received regulatory approval. The Phase 3 trial is actively recruiting participants to assess the drug's effectiveness and safety compared to placebo.
BHV-1300 is being studied in two clinical trials. NCT06980649 is a Phase 1 study with 15 participants in the United States and Australia. NCT07661056 is a Phase 3 study with 300 participants in the United States. Both trials are recruiting adults with Graves Disease.
BHV-1300 is a distinct investigational small molecule that targets IgG, a mechanism that differs from traditional treatments for Graves Disease. It is not known to be the same as any other approved drug. Its unique approach is being evaluated in clinical trials to determine its potential role in managing the condition.