Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ST-920 · 1 trial · 1 indication
All incidences of Treatment-Emergent Adverse Events (TEAEs) in subjects who receive ST-920 as assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Incidences of Treatment-Emergent Adverse Events (TEAEs) directly related to ST-920 in subjects who receive ST-920 as assessed by Common Terminology Criteria for Adverse Events (CTCAE)
All incidences of serious Treatment-Emergent Adverse Events (TEAEs) in subjects who receive ST-920 as assessed by Common Terminology Criteria for Adverse Events (CTCAE)
All incidences of Treatment-Emergent Adverse Events (TEAEs) that lead to study discontinuation or withdrawal in subjects who receive ST-920 as assessed by Common Terminology Criteria for Adverse Events (CTCAE)
| Arm | Type | Description |
|---|---|---|
| Sequential dose escalation | EXPERIMENTAL | ST-920 is administered as a single infusion: 1. Cohort 1: 0.5e13 vg/kg 2. Cohort 2: 1.0e13 vg/kg 3. Cohort 3: 3.0e13 vg/kg 4. Cohort 4: 5.0e13 vg/kg |
| Expansion Cohorts | EXPERIMENTAL | 1. Anti Alpha-Gal A Antibody Positive Cohort 2. Anti Alpha-Gal A Antibody Negative Cohort 3. Female Cohort 4. Renal Cohort 5. Cardiac Cohort |
| Name | Type | Description |
|---|---|---|
| ST-920 | BIOLOGICAL | Single dose of investigational product ST-920 |
Inclusion Criteria: * ≥ 18 years of age * Documented diagnosis of Fabry disease * One or more of the following symptoms: i) cornea verticillata, ii) acroparesthesia, iii) anhidrosis, iv) angiokeratoma * Subject must be fully vaccinated (as per the Centers for Disease Control and Prevention (CDC) de...
ST-920 is an investigational gene therapy being studied for the treatment of Fabry Disease, a rare genetic disorder. It is designed to deliver a functional copy of the alpha-galactosidase A gene to patients. ST-920 is currently in clinical development and has not been approved by regulatory authorities.
ST-920 is being developed by Sangamo Therapeutics, Inc., a biotechnology company traded on the Nasdaq under the ticker symbol SGMO. The company is conducting clinical trials to evaluate the safety and efficacy of ST-920 in patients with Fabry Disease.
ST-920 is in Phase 1 clinical development. It has completed a Phase 1 dose-ranging study in subjects with Fabry Disease. As an investigational therapy, ST-920 is not yet approved and remains under evaluation in clinical trials.
ST-920 has been studied in one clinical trial, identified as NCT04046224, titled "Dose-Ranging Study of ST-920, an AAV2/6 Human Alpha Galactosidase A Gene Therapy in Subjects With Fabry Disease (STAAR)." This Phase 1 trial has been completed and enrolled 36 participants across multiple countries.
ST-920 is a gene therapy designed to treat Fabry Disease. It uses an AAV2/6 vector to deliver the human alpha-galactosidase A gene. The completed Phase 1 trial, STAAR, evaluated dose-ranging of ST-920 in patients with Fabry Disease.