GVHD Program Overview Kalytera
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.
Program Highlights
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-concept1
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