Kalytera Therapeutics (TSXV: KALY) is a clinical-stage pharmaceutical company developing cannabidiol (“CBD”), and next-generation cannabinoid therapeutics, for the treatment of serious and life threatening human disease, with an initial focus on graft versus host disease (“GVHD”).
In our lead program, we are evaluating CBD for the prevention and treatment of graft versus host disease (“GVHD”). Our GVHD program is in late-stage clinical testing. We have an ongoing Phase 2 clinical study in prevention of GVHD, and we expect to initiate a seamless Phase 2-3 pivotal registration study in treatment of acute GVHD later this year. We have two issued U.S. patents covering the use of CBD in the prevention treatment of GVHD, as well as four orphan drug designations for the treatment and prevention of GVHD in the U.S. and Europe.
In addition to our lead program in GVHD, we have also initiated a preclinical program to develop a novel, proprietary cannabinoid compound for the treatment of acute and chronic pain. Our compound consists of a next-generation cannabinoid compound 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, without the risks of addiction or respiratory suppression that exist with opioid analgesics. We have found a way to make this compound water soluble, which will allow for treatment of acute pain in in-patient settings, such as childbirth, short surgical procedures, and post-operative pain care. We have applied for patent coverage in the U.S, Europe and other jurisdictions for this novel cannabinoid compound for the treatment of pain.