EM Orphan Disease Therapy
Our initial clinical development focus will be on clinical studies of a significant group of more homogenous patients with primary erythromelalgia associated with one or more genetic mutations in voltage-gated sodium channels. For our purposes, we expect to diagnose EM patients for our clinical studies by their characteristic symptoms, signs, provocation tests (hot water immersion), quantitative sensory testing, and DNA genetic mutational analyses. Related disorders that may possibly be treated with our therapeutic candidate in the future include small fiber neuropathies, complex regional pain syndrome (CRPS), musculoskeletal disorders and pain and burning from: Fabry’s, essential thrombocythemia (thrombocytosis), polycythemia vera, systemic lupus erythematosus (SLE), underlying benign tumors or malignancies, and/or other disorders and conditions with symptoms similar to EM.
Adolore programs are focused on localized delivery of our biotherapeutics to decrease the excitability of these nociceptive sensory neurons to control chronic EM pain. We anticipate that clinically relevant routes of administration will be available for these therapeutics including ‘nerve blocks’ and/or intra-articular joint injections. ADB-101 is a state-of-the-art JDNI8 rdHSV-CA nontoxic gene therapy designed to target sensory nerve fibers that are hyperexcitable in EM patients to relieve their chronically recurrent difficult to treat neuropathic pain.