More than 20 percent of adults in the United States live with chronic pain. For many affected individuals, long-term physical discomfort negatively impacts overall well-being, leading to reduced job performance and increased anxiety and depression. Over time, these people are likely to become dependent on pain relievers, especially highly addictive prescription opioids, which can lead to a substance use disorder.
However, there may be effective alternatives to prescription opioids. Among them is cannabidiol (CBD), a non-psychoactive substance derived from the cannabis plant. In particular, a CBD analogue known as KLS-13019 has shown tremendous promise in preclinical studies as an alternative to opioids. Now, thanks to a new National Institutes of Health Small Business Innovation Research (SBIR) Phase 2 award, scientists at the Lewis Katz School of Medicine at Temple University have the opportunity to explore further the therapeutic potential of KLS-13019.
The Phase 2 SBIR is a collaboration between Temple University and Kannalife Sciences, a subsidiary of Pennsylvania-based biopharmaceutical and phytomedical company Neuropathix, Inc., which developed and patented KLS-13019. As part of a previous Phase 1 SBIR, the Temple team, led by Sara Jane Ward, PhD, assistant professor of pharmacology at the Lewis Katz School of Medicine, studied KLS-13019 activity in mice. Researchers have shown that the compound effectively prevents and reverses chemotherapy-induced peripheral neuropathy (CIPN) in mice, thus laying the groundwork for the new Phase 2 SBIR.
Temple will receive $ 200,000 for the first year of the grant, which will span three years, with a total of $ 2.9 million going directly to Kannalife Sciences. Dr. Ward and Douglas Brenneman, PhD, chief pharmacologist at Neuropathix, are the co-principal investigators of the grant.
We are delighted to be able to continue our studies on KLS-13019 with the new grant. Our goal now is to test the effects of the compound in a model of neuropathic pain in rats, which will allow us to gain new knowledge about how KLS-13019 works and explore its safety in more detail. “
Dr Sara Jane Ward, PhD, Assistant Professor of Pharmacology, Lewis Katz School of Medicine
Neuropathic pain is often felt as a tight, tingling, or burning sensation, which can come and go and can progress to numbness or a constant feeling of discomfort. Neuropathic pain is a hallmark of peripheral neuropathy, which develops as a result of damage to nerves outside the brain and the spinal cord. The condition typically causes weakness, numbness, and pain, usually in the hands and feet. NHIC is a side effect of some cancer treatments and is easily replicated in animal models, where researchers can accurately assess pain responses and pain sensitivity in animals.
Animal studies have shown that CBD reduces behaviors associated with neuropathic pain. However, CBD may have limited effectiveness in humans, due to its low bioavailability, from the extent to which the drug reaches its site of action. In comparison, KLS-13019 has greater bioavailability, and it appears to both reduce and reverse sensitivity to painful stimuli in animals with established peripheral neuropathy.
“In addition to knowing whether prevention or reversal of ICNP in mice will pass to rats, we also want to know if animals develop tolerance to KLS-13019 and if the compound has a risk of abuse,” said explained Dr. Ward. Tolerance and the potential for abuse are of paramount importance in the effort to reduce the risk of substance abuse disorders in patients who require long-term pain relievers.
“Our goal is to make pain management safer and more effective, which will help ensure the well-being and a high quality of life for patients with chronic pain,” added Dr. Ward.
The research reported in this publication was supported by the National Institute of Neurological Disorders And Stroke (NINDS) of the National Institutes of Health (NIH) under Assignment Number R42NS120548, “Development of KLS-13019 for Neuropathic Pain”. The content is the sole responsibility of the authors and does not necessarily represent the official opinions of the National Institutes of Health.
Temple University Health System