Chronic pain can affect more than 20% of Americans. For many people affected chronic physical discomfort affects overall well-being, leading to reduced productivity at work and an increase in anxiety and depression. As time passes, these people will likely become dependent on pain relievers particularly highly addictive prescription opioids, which can result in a substance use disorder.
There are alternatives to prescription opioids however. Among them is cannabidiol (CBD) which is an inert substance that is not psychoactive and comes from Cannabis. Research has demonstrated that KLS-13019, a CBD analog is a great option for opioid replacement. Now thanks to a new Phase 2 Small Business Innovation Research (SBIR) award from the National Institutes of Health, Scientists at the Lewis Katz School of Medicine at Temple University have the opportunity to further investigate the therapeutic potential of KLS-13019.
The Phase 2 SBIR is a collaboration between Temple University and Kannalife Sciences, which is a subsidiary of Pennsylvania-based biopharmaceutical and phyto-medical firm Neuropathix, Inc., which developed and patented KLS-13019. The Temple team was led by Sara Jane Ward PhD, Assistant Professor of Pharmacology at the Lewis Katz School of Medicine. They investigated KLS-13019’s activity in mice in the previous Phase 1 SBIR. The new SBIR in Phase 2 was initiated after the team’s researchers demonstrated that KLS-13019 effectively prevented and reversed the effects of chemotherapy-induced peripheral neuropathy in mice.
The grant will provide Temple with $200,000 for the first year. The grant will run for three years, with $2.9M funds going to Kannalife Sciences. Dr. Ward and Douglas Brenneman, PhD, Chief Pharmacologist at Neuropathix are co-principal investigators on the grant.
With the new grant, we are thrilled to be able to continue our research into KLS-13019. Now, we’re looking to test the compound’s effects in a rat model for neuropathy. This will provide us with new insight into the mechanism that KLS-13019 works and enable us to study its safety.
Dr. Sara Jane Ward PhD Assistant Professor of Pharmacology in the Lewis Katz School of Medicine
Neuropathic pain is typically felt as shooting, tingling, or burning pain sensations which may come and go and then progress to feeling of numbness or continual discomfort. The most prominent characteristic of peripheral neuropathy is neuropathopathic pain. It develops from damage to nerves that are outside of the spinal cord and brain. The condition is typically characterized by weakness, numbness, or pain, most often in the hands and feet. CIPN is an effect of certain cancer treatments. It is easily replicated in animal models, where researchers can assess the accuracy of animals’ reactions to pain and sensitivity.
Studies on animals have proven that CBD reduces the behaviors related to neuropathy. CBD might not be effective in humans, due to its low bioavailability and the degree to the drug can reach its target of action. KLS-13019, on the contrary on the other hand, has a higher bioavailability and appears to reduce and alleviate pain in animals suffering from peripheral neuropathy.
“In addition to determining whether prevention or reversal of CIPN in mice will carry over to rats, we would like to know if animals develop tolerance to KLS-13019 and whether the compound has any risk of abuse,” Dr. Ward explained. Tolerance and the potential for abuse are the most important factors in reducing the risk of substance abuse disorders in patients who are taking long-term pain medication.
Dr. Ward stated that the goal of pain management is to make it more secure and more efficient. This will assist patients suffering from chronic pain as well as enhance their health and well-being.
The National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), awarded the award number R42NS120548, “Development of KLS-1319 for Neuropathic pain.” The authors are the sole responsible for the content and do not necessarily reflect the official views of the National Institutes of Health.
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