Kalytera announces data elucidating CBD�s mechanisms of action in prevention of GVHD.

Kalytera Therapeutics, Inc. announced new laboratory findings demonstrating that cannabidiol (“CBD”) acts through a distinct biological pathway to restore epithelial cell tight junction integrity, which is highly important in preventing acute graft versus host disease (“GVHD”) and associated comorbidities. Acute GVHD is a life-threatening complication commonly occurring after bone marrow transplant procedures.Prior to the bone marrow transplant, patients typically undergo a total body irradiation (“TBI”) procedure. The TBI procedure damages the patient’s epithelial cells, including those that line the GI tract. This damage breaks down the tight junction barrier that healthy epithelial cells provide. This loss of barrier integrity predisposes the patient to infection and overwhelming sepsis (blood poisoning) as bacteria from the gut microbiome pass through the damaged epithelial cell barrier and enter the patient’s bloodstream. Damage to the epithelial cell lining of the GI tract is a serious and life-threatening comorbidity of acute GVHD, and sepsis is the main cause of death in patients with severe acute GVHD. Following the bone marrow transplant, patients are at significant risk of developing acute GVHD. Acute GVHD is an immune disorder that occurs when immune cells from the bone marrow donor (known as the graft) attack or reject the organs and tissues of the patient (the host). It is estimated that up to 50% of patients who undergo a bone marrow transplant from a sibling donor, and up to 70% of patients who undergo a bone marrow transplant from an unrelated donor, will develop some level of GVHD. There are currently no FDA approved therapies for either the prevention or treatment of acute GVHD.

“An ideal preventive therapy for acute GVHD would act to both repair the damage to epithelial cells caused by the TBI procedure, and act as an immunosuppressant to suppress the attack by the donor’s immune cells against the patient’s organs and tissues. It is already well established that CBD acts as an immunosuppressant, and now Kalytera research confirms that CBD also acts through a distinct biological pathway to repair the damage to epithelial cells caused by the TBI procedure,” stated Robert Farrell, Kalytera’s President and CEO. “Our laboratory findings, as well as research done by others, demonstrate that CBD has a dual mechanism of action that might be ideal for prevention of acute GVHD.”

Results from Kalytera’s research demonstrate that CBD repaired epithelial tight junctions in a cell culture model of acute gut inflammation. Kalytera used this model to demonstrate for the first time that CBD exhibits pharmacologic activity through a nuclear protein called the aryl hydrocarbon receptor, or AhR. AhR activation is known to improve intestinal epithelial barrier function by maintaining the integrity of tight junctions. The Company’s data demonstrate that CBD has a dramatic effect on the AhR signaling pathway, resulting in a 23-fold increase in activation of this pathway in the cell culture model used in this research. These data underscore the significant role that CBD may play in repair of epithelial barrier damage.

Comment CBD is a non-psychotropic ingredient of cannabis that does not cause euphoria or cognitive effects. The formulation of CBD that Kalytera is evaluating for the prevention and treatment of acute GVHD is a proprietary formulation that is designed to improve product stability and absorption after oral dosing.