Kalytera Therapeutics (TSXV: KALY) is a clinical-stage pharmaceutical company pioneering the development of a next generation of cannabinoid therapeutics. Through its proven leadership, drug development expertise, and intellectual property portfolio, Kalytera seeks to establish a leading position in the development of novel cannabinoid medicines for a range of important unmet medical needs, with an initial focus on Graft versus Host Disease (“GvHD”). Kalytera is also developing a new class of proprietary cannabidiol (“CBD”) therapeutics. CBD is a remarkable compound that has shown activity against a number of pharmacological targets. However, there are limitations associated with natural CBD, including its poor oral bioavailability. Kalytera is developing innovative CBD formulations and prodrugs in an effort to overcome these limitations, and to target specific disease sites within the body. Kalytera intends to file composition of matter and method of use patents covering its novel inventions, with the goal of limiting future competition.
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 common, life-threatening complication of hematopoietic stem cell transplant (“HCT”) 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 >>
- Four Phase 2a clinical trials complete, one published study demonstrating proof-of-concept
- Orphan Drug Designation (“ODD”) granted in U.S. and Europe
- Urgent unmet need; there are currently no FDA approved therapies for the prevention or treatment of GvHD in its acute and chronic forms
- Advancing towards Phase 2b randomized, placebo-controlled clinical studies
Cases of Acute Graft versus Host Disease
Source: GlobalData; Jagasia et al., 2012; Pasquini and Wang, 2013
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 >>
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.
Proprietary Analogues of Cannabis-like Molecules
Kalytera seeks to advance a portfolio of synthetic, non-psychoactive cannabis-like molecules. By modifying cannabinoid molecules, and molecules which regulate the endogenous cannabinoid signaling system, 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.