Sangamo gets FDA clearance of IND application for ST-503 in iSFN

The company states: “Sangamo (SGMO) Therapeutics announced that the FDA has cleared the investigational new drug application for its ST-503 program, an investigational epigenetic regulator for the treatment of intractable pain due to idiopathic small fiber neuropathy, or iSFN, a type of chronic neuropathic pain. Neuropathic pain can be caused by a broad array of pathologies impacting the central or peripheral nervous systems, such as surgical trauma, spinal cord injury, nerve compression, neurological and infectious diseases, or metabolic and hereditary syndromes. ST-503 is not intended for sporadic or acute pain, but for chronic, intractable pain that completely dominates and often destroys the lives of patients over many years. The Phase 1/2 study will assess the safety and efficacy of ST-503 in addressing iSFN, a peripheral neuropathy that results in highly debilitating symptoms of burning, prickling, stabbing or “lightning-like” pain. iSFN has an estimated prevalence of at least 43,000 patients in the U.S., and more broadly, peripheral neuropathies are estimated to affect nearly 40 million Americans. Antidepressants, anticonvulsants, opioids and topical therapies are potential treatment options, although no long-lasting or curative therapies are currently available for iSFN patients, leading to a high unmet medical need for this patient population. Sangamo is preparing for the Phase 1/2 clinical study to assess the safety, tolerability and preliminary efficacy of a one-time dose of ST-503, administered intrathecally to patients with intractable pain due to iSFN, and plans to initiate patient enrollment in mid-2025. Sangamo believes that if this study is successful, the development of ST-503 could be broadened to patient populations suffering from other types of chronic neuropathic pain.”