Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 developed by Sangamo Therapeutics for neurological conditions. It has been studied in Phase 2 clinical trials in amyotrophic lateral sclerosis (ALS) and in diabetic neuropathy associated with type 1 and type 2 diabetes. All four of its recorded trials are completed, and none are currently active.
SB-509 was studied as a treatment for amyotrophic lateral sclerosis and for diabetic polyneuropathy in people with type 1 or type 2 diabetes. Its Phase 2 trials enrolled adults 18 years and older of all sexes. These studies are completed, and SB-509 is not described as an approved therapy for either condition.
SB-509 was developed by Sangamo Therapeutics, Inc., which trades under the ticker SGMOQ. Sangamo sponsored the Phase 2 clinical program evaluating SB-509 in amyotrophic lateral sclerosis and diabetic neuropathy. The program includes four completed trials with a combined enrollment of 394 participants across sites in the United States and Mexico.
SB-509 reached Phase 2 clinical development. All four of its recorded trials are Phase 2 studies and all are completed, with no active trials ongoing. SB-509 is an investigational agent rather than an approved product, and its studied indications were amyotrophic lateral sclerosis and diabetic neuropathy in type 1 and type 2 diabetes.
SB-509 has been evaluated in four completed Phase 2 trials: NCT01079325 in diabetic neuropathy with 170 participants, NCT00748501 in ALS with 45 participants, NCT00665145 on stem cell mobilization in diabetic neuropathy with 23 participants, and NCT00476931 in diabetic neuropathy with 91 participants. The studies were active controlled and included randomized designs.
Across its four completed Phase 2 trials, SB-509 studies enrolled a total of 394 participants. The largest was NCT01079325 in diabetic neuropathy with 170 participants, followed by NCT00476931 with 91, NCT00748501 in ALS with 45, and NCT00665145 with 23. All trials enrolled adults aged 18 years and older.