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.
Graft versus Host Disease ("GVHD") Program
Kalytera is developing a clinical-stage cannabidiol (“CBD”) medicine to prevent and treat graft versus host disease (“GVHD”). GVHD is a multisystem disorder that is a life-threatening complication commonly occurring after bone marrow transplant procedures. GVHD occurs when the transplanted donor cells attack the patient’s organs, including the skin, gastrointestinal tract, liver, lungs, and eyes. GVHD is associated with acute and chronic illness, infections, disability, reduced quality of life, and death. Learn more >>
The commercial opportunity for our CBD therapeutic in the prevention and treatment of GVHD is large. According to the January 2018 Market Forecast Report by DelveInsight Perspective, projected annual sales in the 7 major markets (the U.S., Germany, France, Italy, Spain, the U.K. and Japan) is estimated to be more than USD $408 million in 2018, and could grow to approximately USD $1.3 billion by 2027.
- Two issued U.S. patents covering the use of CBD in the prevention and treatment of GVHD
- Four orphan drug designations granted in U.S. and Europe for the treatment and prevention of GVHD
- Four Phase 2a clinical trials complete, one published study demonstrating proof-of-concept
- Urgent unmet need: there are currently no FDA approved therapies for the prevention or treatment of GVHD
- Advancing towards Phase 2b randomized, placebo-controlled clinical studies
- Phase 2 clinical study ongoing in prevention of GVHD, and a seamless Phase 2-3 pivotal registration study in treatment of acute GVHD expected to commence later this year
Acute and Chronic Pain Program
Kalytera has initiated a novel program for the treatment of acute and chronic pain through the development of a compound that consists of a cannabinoid conjugated with naproxen, a generic, non-steroidal, anti-inflammatory drug that is already approved for treatment of pain. The objective of Kalytera’s new program is to develop a potent, non-psychotropic, oral analgesic for intractable pain that will be safe and well tolerated.
By combining both molecules into a single drug, Kalytera has designed a next generation pain medication that may maximize the activation of the alpha3 glycine receptor pathway for treatment of intractable pain. To our knowledge, no company has introduced into the market an agent specifically targeting this receptor. The initial route of administration will be oral, Kalytera will also seek to develop an intravenous formulation. Learn more >>
Structure of Naproxen
Why Focus on CBD?
Cannabis, also known as marijuana, is a flowering plant recognized for its medicinal and recreational uses. Cannabis acts on the endocannabinoid system, a system of endogenous receptors that may have a mediating role in inflammation, nausea, pain, and many other biological functions. Attracted by its low toxicity and early proof of efficacy, the mainstream medical establishment has begun to actively explore the use of cannabis for a variety of ailments.
Cannabis has over 80 chemical constituents, known as “cannabinoids”, which alter neurotransmitter release from the brain. Two of the most active and studied constituents of cannabis are tetrahydrocannabinol (“THC”) and cannabidiol (“CBD”). THC is the major psychoactive component of cannabis. CBD acts on many of the same receptors as THC, but without the psychoactive side effects.
CBD was first discovered by Dr. Roger Adams and his team at the University of Illinois in 1940. While CBD was discovered more than 20 years before THC, THC has dominated cannabis research until recently. Recent evidence suggests that CBD has potential therapeutic benefits for a wide range of conditions. Learn more about CBD >>
Focus on Non-Psychoactive Cannabinoid Products
To expedite regulatory approval and commercialization, Kalytera intends to explore the use of CBD, a non-psychoactive cannabis constituent. A large body of research supports CBD’s safety profile.
Focus on Proprietary Cannabis Compounds
Kalytera seeks to advance a portfolio of novel, non-psychoactive cannabis compounds. By modifying cannabinoid molecules, Kalytera seeks to improve pharmacokinetics and increase potency, potentially allowing for the development of drug candidates with improved activity.
Focus on Orphan Conditions
Kalytera will also focus on orphan conditions, with the goal of generating data in humans that may support follow-on studies in major conditions. Orphan designations often carry additional terms of marketing exclusivity and procedures to accelerate regulatory approvals.
Focus on Strategic Partnering Opportunities
As we advance our GVHD program into the final phases of clinical testing, we will begin seeking regional partnering opportunities outside of North America to provide non-dilutive sources of funding and monetize this program through licensing, milestone and royalty revenue. In our pain program, our strategy is to advance our proprietary cannabis 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.