Developing a Non-psychotropic Cannabinoid-based Drug for Pain

Kalytera Therapeutics has announced the formation of a Strategic & Scientific Advisory Board with three key appointments: Professor Joseph Lynch, Ph.D.; Dr. Li Zhang; and Professor Hanns Ulrich Zeilhofer.

The Strategic and Scientific Advisory Board will work closely with Kalytera’s management to advance the company’s novel cannabinoid-based technology for the treatment of acute and chronic pain, identify new applications for Kalytera’s cannabinoid technology, and provide insight regarding new cannabinoid-based technologies to complement the company’s pipeline.

"We are thrilled to have attracted some of the world's leading experts in pain to our Strategic and Scientific Advisory Board," said Robert Farrell, Kalytera’s President and Chief Executive Officer. "The formation of our SSAB further validates the scientific and clinical merit for our pain product and our pipeline of CBD based pharmaceuticals."

Professor Joseph Lynch, Ph.D.

Dr. Lynch completed a BSc majoring in Physics at the University of Melbourne. He then moved to the University of New South Wales to undertake a Masters of Biomedical Engineering, and then a Ph.D. in Physiology. His postdoctoral studies were undertaken in Germany, France and at the Garvan Institute of Medical Research in Sydney. He moved to University of Queensland in 1996 as a Senior Lecturer in the School of Biomedical Sciences, and was awarded an NHMRC Senior Research Fellowship in 2004 (renewed in 2009). He relocated to the Queensland Brain Institute in October 2007.

Dr. Li Zhang

Dr. Zhang has worked as an NIH Staff Scientist in the Laboratory for Integrative Neuroscience since 2004. He is an expert in neuropharmacology, and has published in Nature Chemistry and Biology, including a paper entitled “Cannabinoid potentiation of glycine receptors contributes to cannabis-induced analgesia.” Kalytera’s novel, proprietary cannabinoid-naproxen conjugate is based in part on Dr. Zhang’s pioneering research demonstrating that cannabinoids suppress inflammatory and neuropathic pain by targeting alpha3 glycine receptors.

Professor Hanns Ulrich Zeilhofer

Dr. Zeilhofer studied medicine at the University of Erlangen in Germany. He did his postdoctoral training at the University of Erlangen, the Max Planck Institute for Biophysical Chemistry and at ETH Zürich. From 2001 to 2005 he was associate professor of Molecular Neuropharmacology at the Institute of Experimental and Clinical Pharmacology and Toxicology, University of Erlangen. In September 2005 he joined the Institute of Pharmacology and Toxicology, University of Zurich, and, in addition, in January 2016, the Swiss Federal Institute of Technology (ETH) Zurich, as a full professor of pharmacology.  He currently serves as the director of the Institute of Pharmacology and Toxicology of the University of Zurich and as a member of the research council of the Swiss National Science Foundation. He is also a founding member of the Drug Discovery Network Zurich (DDNZ). His research has been supported by grants from the European Research Council (ERC), the Swiss National Science Foundation and the Wellcome Trust, among others. His research has led to the identification of alpha3 glycine receptors as promising targets in chronic pain conditions. Dr. Zeilhofer has received scientific prizes from the SANDOZ-Foundation for Therapeutic Research, the German Association for the Study of Pain, the Sertürner Society and the PHOENIX Pharmacy award.

"The background and experience of these three experts will be invaluable as we move through IND-enabling studies toward initial clinical testing,” stated Farrell. “A major focus of their research has been the molecular structure and function of the alpha3 glycine receptor that mediates inhibitory neurotransmission in the brain. Kalytera’s cannabinoid-naproxen conjugate is intended to target the alpha3 glycine pain receptor, which has recently emerged as a promising therapeutic target for pain. Drs. Lynch, Zhang and Zeilhofer are leaders in this field of research, and I am very proud to have them join us as founding members of our Strategic & Scientific Advisory Board established in connection with this novel cannabinoid-based technology for the treatment of pain.”

Developing a cannabinoid-based drug to treat pain 

Kalytera’s compound in development for treatment of pain consists of a cannabinoid conjugated with naproxen, a generic, non-steroidal, anti-inflammatory drug that is already approved for treatment of pain. This cannabinoid/naproxen conjugate has potential to become a next generation pain medication, and, based on the potentially complementary methods of action of the cannabinoid and naproxen, there is reason to believe these molecules may have a synergistic effect in treatment of pain, as well as a superior safety profile compared with opioid analgesics.

The objective of Kalytera’s program is to develop a potent, non-psychotropic, oral analgesic for intractable pain that will be safe and well tolerated. The cannabinoid component will act as a cannabinoid receptor agonist, targeting the alpha3 glycine pain receptor in the spinal cord, and the naproxen component will block the synthesis of the pain-inducing molecule PGE2. Although the initial route of administration will be oral, Kalytera will also seek to develop an intravenous formulation.

Kalytera believes that its product will be suitable for mild to severe pain, without the risks of respiratory suppression and dependence associated with opioid analgesics.

Kalytera’s strategy will be to advance this compound through Phase 1 and Phase 2 clinical testing, and then seek to out-license or sell the program to a multinational pharmaceutical company. If successful, the commercial opportunity for this program could be very significant.