Approval Probability
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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 Type 1 Diabetes Mellitus and Amyotrophic Lateral Sclerosis (ALS). In clinical trials, it has also been studied in patients with diabetic polyneuropathy, a complication of diabetes. It is currently in Phase 2 clinical development.
SB-509 is being developed by Sangamo Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol SGMO. The company has conducted multiple clinical trials of SB-509 in diabetic neuropathy and ALS.
SB-509 is in Phase 2 clinical development. All four clinical trials for SB-509 have been completed, with no active trials currently ongoing. The drug remains investigational and has not been approved by regulatory authorities.
SB-509 has been studied in four completed Phase 2 clinical trials. These include NCT00476931 and NCT01079325 in diabetic neuropathy, NCT00665145 in stem cell mobilization for diabetic neuropathy, and NCT00748501 in amyotrophic lateral sclerosis (ALS). Total enrollment across these trials was 394 participants.
SB-509 is classified as a small molecule therapeutic, not a gene therapy. It is being developed by Sangamo Therapeutics for the treatment of Type 1 Diabetes Mellitus and Amyotrophic Lateral Sclerosis. The drug has been evaluated in randomized, active-controlled clinical trials.