Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AAV9-hSyn1-miGRIK2
AMT-260 · 1 trial · 1 indication
Occurrence of Adverse Events during the period of 1 year after AMT-260 administration, including seriousness, severity, and causal relationship to AMT-260.
| Arm | Type | Description |
|---|---|---|
| AMT-260 | EXPERIMENTAL | Cohort 1: AMT-260 starting dose (1.0x 10E12 gc/mL). Cohort 2: AMT-260 adapted dose (6.0x 10E11 gc/mL or 3.0x 10E12 gc/mL). |
| Name | Type | Description |
|---|---|---|
| AAV9-hSyn1-miGRIK2 | GENETIC | AMT-260 is an AAV9 gene therapy product that locally delivers miRNA silencing technology to target the GRIK2 gene and suppress aberrantly expressed GluK2 containing kainate receptors. Intervention will be a one-time intracerebral administration of AMT-260. |
Inclusion Criteria: * Diagnosis of unilateral refractory MTLE * History of seizures with an average of ≥ 2 documented focal impaired awareness seizures or focal to bilateral tonic-clonic seizures per 30-day period over the 3 month Retrospective Period. * On a stable type and dose regimen of up to a...