SB0101 consists of a formulation of the sensory survival and regenerative factor Neublastin (NBN). During the nervous system development, NBN supports the growth, differentiation, and function of sensory neurons. By readministering NBN in conditions of diseased sensory neurons, including sciatica and PDN, we leverage the natural reparative mechanism of NBN to repair injured sensory neurons, restore sensory function, and to alleviate the pain.
NBN mediates signaling by binding to the GDNF family receptor alpha 3 receptors (GFRalpha3), which are selectively expressed on sensory neurons. NBN can therefore be administered systemically to target sensory neurons in an effective and still selective manner.
NBN has demonstrated extraordinary therapeutic activity in multiple preclinical models of traumatic neuronal injury. Indeed, NBN has been shown to mediate neuroprotection, promote neuronal regeneration, and restore neuronal and tissue connectivity both at distal nerve endings and at the level of the spinal cord. NBN has also been demonstrated to normalize biomarkers of neuropathic pain.
Collectively these data indicate that NBN exhibits a great and broad spectrum of therapeutic activities and has the potential to become a transformational treatment of sciatica and PDN, as well as for other conditions of traumatic nerve injury and neuropathic pain.