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ALXN2350 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| ALXN2350 | EXPERIMENTAL | Participants will receive one of three dose levels of ALXN2350 depending on the cohort. |
| Name | Type | Description |
|---|---|---|
| ALXN2350 | DRUG | ALXN2350 is a gene therapy product consisting of an AAV9 capsid containing BAG3 transgene. It is administered as a single intravenous (IV) infusion. |
Inclusion Criteria: * Pathogenic or likely pathogenic mutation in BAG3 * Medical history of diagnosis of DCM * Stable combination of HF SoC medications * Adequate acoustic windows for echocardiography * LVEF \> 15% and ≤ 45% at Screening by echocardiography * Diagnosis of chronic HF for at least 3 ...
ALXN2350 is an investigational small molecule being developed by AstraZeneca PLC for BAG3 mutation associated dilated cardiomyopathy, a genetic form of heart muscle disease. It is currently in Phase 1 clinical development and has not been approved by the FDA. The program is biomarker selected, meaning it targets patients with a specific BAG3 mutation.
ALXN2350 is being studied as a potential treatment for adults with dilated cardiomyopathy associated with BAG3 mutations. This is a genetic condition that can lead to progressive heart failure. The drug is investigational and has not been approved for any indication. It is being evaluated in a Phase 1 trial that is currently recruiting.
ALXN2350 is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca is the sponsor of the ongoing Phase 1 clinical trial for the drug.
ALXN2350 is in Phase 1 clinical development. The only trial listed for this drug is a Phase 1 study that is currently recruiting participants. There are no completed trials for ALXN2350. It is an investigational therapy and has not received FDA approval.
ALXN2350 is being evaluated in a single Phase 1 trial, NCT07218887, titled "ALXN2350 in Adult Participants With BAG3-Associated Dilated Cardiomyopathy." The trial is recruiting and plans to enroll 6 participants. It is an uncontrolled, open-label study taking place in the United States, Italy, Spain, and the United Kingdom.