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ST-503 · 1 trial · 1 indication
To assess safety and tolerability of ST-503 over a 12-week post-dosing observation period.
| Arm | Type | Description |
|---|---|---|
| Sham Controlled Study | SHAM_COMPARATOR | - |
| Investigational Agent | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ST-503 | GENETIC | Genomic Medicine |
| Sham (No Treatment) | PROCEDURE | Sham Procedure |
Inclusion Criteria 1. Diagnostic characterization of Small Fiber Neuropathy (SFN) according to the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities and Networks (ACTTION) criteria. 2. Medical record documentation that pain is refractory to 2 of 3 categori...
ST-503 is an investigational gene therapy being developed for chronic neuropathic pain. It is specifically being studied in patients with refractory pain due to peripheral neuropathy, including small fiber predominant neuropathy (SFN). The drug is administered as a sham-controlled treatment in a Phase 1 clinical trial.
ST-503 targets the Nav1.7 gene, which encodes a voltage-gated sodium channel involved in pain signaling. By delivering this gene, the therapy aims to address the underlying genetic contribution to chronic neuropathic pain. The drug is designed to work at the genetic level to potentially provide long-lasting pain relief.
ST-503 is developed by Sangamo Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol SGMO. Sangamo is conducting the Phase 1 clinical trial for ST-503 in the United States, focusing on patients with chronic neuropathic pain due to peripheral neuropathy.
ST-503 is currently in Phase 1 clinical development. The ongoing trial, NCT06980948, is a randomized, double-blind, sham-controlled study evaluating the safety and tolerability of ST-503 in patients with refractory pain due to peripheral neuropathy. The trial is recruiting participants and has not yet been approved by regulatory authorities.
ST-503 is being studied in one active Phase 1 clinical trial, NCT06980948, titled "Safety and Tolerability Study of ST-503 for Refractory Pain Due to Peripheral Neuropathy (Small Fiber Predominant, SFN)." The trial is recruiting 27 participants in the United States and is randomized, double-blind, and sham-controlled.
ST-503 is not FDA approved. It is an investigational drug currently in Phase 1 clinical trials. The FDA has granted ST-503 Fast Track designation, which is intended to expedite the development and review of drugs that treat serious conditions and fill an unmet medical need, but approval has not yet been granted.