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Also known as BMS-986446 IV, PRX005, Moponetug
BMS-986446 · 2 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| BMS-986446 Dose A | EXPERIMENTAL | - |
| BMS-986446 Dose B | EXPERIMENTAL | - |
| Panel A1: BMS986446 | EXPERIMENTAL | - |
| Panel A2: BMS986446 | EXPERIMENTAL | - |
| Panel A3: BMS986446 | EXPERIMENTAL | - |
| Panel B1: BMS986446 | EXPERIMENTAL | - |
| Panel B2: BMS986446 | EXPERIMENTAL | - |
| Panel C1: BMS986446 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| BMS-986446 | DRUG | Specified dose on specified days |
| Placebo | OTHER | Specified dose on specified days |
Inclusion Criteria * Mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild AD dementia consistent with the National Institute on Aging and the Alzheimer's Association (NIA-AA) core clinical criteria. * Global Clinical Dementia Rating (CDR) score of 0.5 to 1.0 and a CDR-Memory Box ...
BMS-986446 is being developed for the treatment of early Alzheimer's disease, including early-onset Alzheimer's disease. It is an investigational therapy and has not been approved for any indication. Clinical development is focused on participants with early Alzheimer's disease, a population where intervention may help slow disease progression.
BMS-986446 targets the microtubule-binding region (MTBR) of tau. It is an anti-MTBR tau monoclonal antibody designed to bind this region of the tau protein. Tau pathology is a hallmark of Alzheimer's disease, and targeting MTBR tau is an approach under investigation for early Alzheimer's disease.
BMS-986446 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker symbol BMY. Bristol-Myers Squibb is the sponsor of the clinical trials evaluating the drug in healthy participants and in patients with early Alzheimer's disease.
BMS-986446 is in Phase 2 clinical development for early Alzheimer's disease. A Phase 2 trial is active but not recruiting, and a Phase 1 trial in healthy adults and participants with early Alzheimer's disease is currently recruiting. The drug remains investigational and has not been approved by the FDA.
BMS-986446 is being evaluated in two registered clinical trials. The Phase 2 trial NCT06268886 is testing efficacy, safety, and tolerability in participants with early Alzheimer's disease across multiple countries. The Phase 1 trial NCT07780383 is assessing drug levels, absolute bioavailability, safety, tolerability, and immunogenicity in healthy adults and participants with early Alzheimer's disease in the United States.
Yes, BMS-986446 IV is another name for BMS-986446. Both refer to the same investigational anti-MTBR tau monoclonal antibody being developed by Bristol-Myers Squibb for early Alzheimer's disease. The IV designation reflects intravenous administration of the drug in clinical trials.