Miller School Anesthesiologist Receives Grant to Study Opioid-free Relief for Chronic Knee Pain
Roy C. Levitt, M.D., professor of Clinical Anesthesiology at the University of Miami Miller School of Medicine, received the National Institutes of Health/NINDS Helping to End Addiction Long-term® Initiative (NIH/NINDS HEAL) UH3 award to support his work in opioid-free analgesic gene therapy to treat knee pain due to knee osteoarthritis (OA).
Gene Therapy, Not Opioids
The award will fund all development work through a first-in-human clinical trial featuring an innovative proprietary carbonic anhydrase-8 (CA8*) analgesic peptide gene therapy, invented by Dr. Levitt for chronic osteoarthritic knee pain. CA8* gene therapy uses a technologically advanced, replication defective (rdHSV) HSV vector system for a local, non-toxic and disease-free delivery via knee injection.
“It is an honor to receive the highly-vetted HEAL UH3 Award from the NIH/NINDS supporting the advancement of our treatment of chronic OA knee pain,” said Dr. Levitt. “This funding enables the collaborating parties to execute on numerous milestones and provides further validation of our innovative approach.”
Pain Relief via Potassium Channel Activation
CA8* gene therapy is believed to regulate neuronal intracellular calcium and thereby control neuronal excitability through the activation of Kv7 voltage-gated potassium channels.
Adolore BioTherapeutics, founded by Dr. Levitt, is the grant’s commercialization partner and will collaborate on GMP manufacturing process development and scale-up, GMP clinical batch manufacturing, GLP-toxicology studies, all analytical development, drug characterization, supplemental pre-clinical work, clinical study design and preparations, and will oversee the clinical study and submit the Investigational New Drug (IND) to the FDA.
An earlier UG3 grant supported pre-clinical development which showed compelling safety and efficacy data in animal models. A single dose of rdHSV-CA8* surpassed an oral dose equivalent of 100mg of oral morphine for an average-sized adult, given throughout the day, every day for over six months.
“Chronic pain continues to be a major health problem worldwide that represents an annual cost of $650 billion in the U.S. and there remains a significant unmet need for safe and effective non-opioid pain therapies,” said Dr. Levitt. “We believe this program has the potential to provide a safe and effective approach to chronic pain management.”