Kalytera Therapeutics is ramping up its cannabidiol program, with ambitions to bring a treatment for graft-versus-host disease into phase 3 by the end of the year. The drug is in phase 2 studies for both the treatment and prevention of GVHD, a life-threatening condition that has no approved therapies.
GVHD is a serious complication of bone marrow transplant, occurring when the transplanted donor cells mount an immune response against the recipient’s healthy tissues and organs. Steroids may be used to try and limit the immune reaction, but this does not work in all patients. Kalytera estimated that about 50% patients who receive a bone marrow transplant from a fully matched sibling donor and up to 70% of patients who receive bone marrow from an unrelated donor will develop "some level" of GVHD.
Cannabidiol (CBD) is a nonpsychotropic ingredient of cannabis—it acts on many of the same receptors as tetrahydrocannabinol (THC), the part of cannabis that causes users to get "high." Cannabis remains classed as a Schedule I drug—meaning it has "no currently accepted medical use and a high potential for abuse"—but the FDA is set to make a decision next week on GW Pharma's CBD treatment for rare epilepsies. An approval would pave the way for other companies, like Kalytera, that are working on cannabis-based treatments.
Kalytera's CBD candidate has completed two phase 2a studies in the prevention of GVHD. One of the studies involved 48 patients who received 150 mg of CBD twice daily for the week leading up to bone marrow transplant, and for 30 days after.