With New NIH Small Business Innovation Research Award, Temple Researchers Set to Test Novel Cannabis Analog in Preclinical Studies

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 work output and increased anxiety and depression. Over time, these individuals are likely to become dependent on pain-relieving medications, especially highly addictive prescription opioids, which can result in a substance use disorder.

There may be effective alternatives to prescription opioids, however. Among them is cannabidiol (CBD), a non-psychoactive substance derived from the Cannabis plant. In particular, a CBD analog known as KLS-13019 has shown exceptional promise in preclinical studies as an opioid alternative. 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 explore the therapeutic potential of KLS-13019.

The Phase 2 SBIR is a collaboration between Temple University and Kannalife Sciences, a subsidiary of Pennsylvania-based bio-pharmaceutical and phyto-medical company Neuropathix, Inc., which developed and patented KLS-13019. Under 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, investigated the activity of KLS-13019 in mice. The researchers showed that the compound effectively prevents and reverses chemotherapy-induced peripheral neuropathy (CIPN) in mice, laying the foundation for the new Phase 2 SBIR.

Temple will receive $200,000 for the first year of the grant, which will run three years, with a total of $2.9M funding going directly to Kannalife Sciences. Dr. Ward and Douglas Brenneman, PhD, Chief Pharmacologist at Neuropathix, are co-principal investigators on the grant.

“We are excited to be able to continue our studies of KLS-13019 with the new grant,” Dr. Ward said. “Our goal now is to test the effects of the compound in a rat model of neuropathic pain, which will allow us to gain new insight into how KLS-13019 works and to more thoroughly explore its safety.”

Neuropathic pain often is felt as shooting, tingling, or burning pain sensations, which may come and go and which may progress into numbness or constant feelings of discomfort. Neuropathic pain is a hallmark feature of peripheral neuropathy, which develops as a result of damage to nerves located outside of the brain and spinal cord. The condition typically causes weakness, numbness, and pain, usually in the hands and feet. CIPN is a side effect of certain cancer treatments and is easily reproduced in animal models, where researchers can accurately assess animals’ pain responses and pain sensitivity.

Studies in animals have shown that CBD reduces behaviors associated with neuropathic pain. CBD may have limited effectiveness in humans, however, owing to its low bioavailability, the extent to which the drug reaches its site of action. By 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 finding out whether prevention or reversal of CIPN in mice will carry over to rats, we also want to know whether animals develop tolerance to KLS-13019 and whether the compound has any abuse liability,” Dr. Ward explained. Tolerance and potential for abuse are of key importance in the effort to reduce the chances for substance abuse disorders among patients who need to take pain medications over the long term.

“Our goal is to make pain management safer and more effective, which will help ensure well-being and a high quality-of-life for patients who suffer from chronic pain,” Dr. Ward added.

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 Award Number R42NS120548, “Development of KLS-13019 for Neuropathic Pain.” The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Editor’s Note: Dr. Sara Jane Ward is Assistant Professor, Center for Substance Abuse Research and Assistant Professor, Neural Sciences at the Lewis Katz School of Medicine at Temple University. Kannalife (a Neuropathix subsidiary) provides testing compounds and funds research activities at Temple University’s Center for Substance Abuse Research under the direction of Dr. Ward. Dr. Ward also serves as a member of Kannalife’s Advisory Board. These activities have been reviewed according to Temple University’s Conflict of Interest (COI) policies, and questions regarding Temple University may be directed to coisom@temple.edu.