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SB-509 · 5 trials · 4 indications
| Arm | Type | Description |
|---|---|---|
| SB-509 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | Saline |
| Cohort 1 | ACTIVE_COMPARATOR | SB-509 drug administration via IM injection of neck, arms, and legs |
| Cohort 2 | ACTIVE_COMPARATOR | SB-509 drug administration via IM injection of legs |
| 1 | EXPERIMENTAL | Cohort 1 |
| 2 | EXPERIMENTAL | Cohort 2 |
| 3 | PLACEBO_COMPARATOR | Cohort 3 |
| 4 | EXPERIMENTAL | Cohort 4 |
| Normal Saline | PLACEBO_COMPARATOR | Normal saline injected IM into lower limbs every 2 months |
| Name | Type | Description |
|---|---|---|
| SB-509 | DRUG | SB-509 60 mg, 3 treatments, and 5 months treatment period |
| Saline | OTHER | - |
| Placebo | DRUG | Placebo |
| Normal Saline | OTHER | - |
Key Inclusion Criteria: * Clinical diagnosis of Diabetes Mellitus Type I or II for at least 12 months * Clinical signs and symptoms of moderate to severe diabetic sensory-motor polyneuropathy of the lower extremities for at least 6 months that are not otherwise attributed to an etiology other than ...
SB-509 is an investigational small molecule being developed for Diabetic Neuropathy, a complication of Diabetes Mellitus Type 1 and Type 2. It has also been studied in Amyotrophic Lateral Sclerosis. The drug is in Phase 2 clinical development and is not yet approved by the FDA.
SB-509 is being developed by Sangamo Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker SGMO. The company has conducted multiple clinical trials of SB-509 in subjects with diabetic neuropathy.
SB-509 is in Phase 2 clinical development. All four clinical trials of SB-509 have been completed, with no active trials currently ongoing. The drug remains investigational and has not received FDA approval for any indication.
SB-509 has been studied in four completed Phase 2 clinical trials: NCT00406458, NCT00476931, NCT00665145, and NCT01079325. These trials enrolled a total of 394 subjects with diabetic neuropathy across the United States and Mexico.
SB-509 is a distinct investigational small molecule developed by Sangamo Therapeutics. It is not the same as other drugs in the company's pipeline. The trials for SB-509 focused on diabetic neuropathy, with enrollment of adults aged 18 years and older.