Kalytera Therapeutics, Inc. (TSX: KALY) (OTC: KALTF), a specialty pharmaceutical company based in Novato, California, is focusing on the evaluation of CBD in the prevention and treatment of acute graft versus host disease (GVHD), among other efforts.
It recently provided an update on its GVHD programs. It plans to:
– announce interim data from the ongoing Phase 2 study later in 2018;
– complete the Phase 2 study in Q2 2019; and
– initiate the Phase 3 clinical study during Q3 2019.
Data from its two similar Phase 2a clinical studies were positive and encouraging.
GVHD is a life-threatening complication commonly occurring after bone marrow transplant procedures, when donor cells attack the patient’s organs, including the skin, GI tract, liver, lungs, and eyes. It’s associated with acute and chronic illness, infections, disability, reduced quality of life, and death.
Up to 50% of patients who get bone marrow transplants from a sibling, and 70% of patients who get them from an unrelated donor, will develop some GVHD. There are currently no FDA-approved therapies for prevention or treatment of acute GVHD.
“…Based on the positive…results from the two prior Phase 2a clinical studies in prevention of GVHD, we are optimistic that our CBD product will address this unmet need, and will be …a safe and effective means to prevent the onset of acute GVHD”, said Robert Farrell, President and CEO of Kalytera.
According to Delve Insight Perspective, the potential market in USA, western Europe, and Japan could be over USD $400 million in 2018, and possibly USD $1.3 billion by 2027. (Delve Insight January 2018 Market Forecast Report).
If Kalytera’s CBD products are approved for this use, Kalytera believes, given the severe nature of this disorder, physicians would be expected to prescribe its approved formulation of CBD rather than a non-approved CBD formulation.
Kalytera is the exclusive licensee of two U.S. patents covering its formulation of CBD for the prevention and treatment of GVHD, and is also the exclusive licensee of pending patent applications in other jurisdictions. It also has four orphan drug designations for the treatment and prevention of GVHD in the U.S. and Europe. Upon regulatory approval, these would provide 7-years of market exclusivity in the U.S., and 10-years in the E.U.
CBD is a non-psychoactive ingredient of cannabis. The formulation of CBD that Kalytera uses is proprietary, designed to improve stability and oral absorption.
Kalytera has begun seeking corporate partners for both GVHD programs. The objective is to provide a non-dilutive funding, and future revenue through licensing fees, milestone payments and royalties.
In the previous Phase 2a study, 48 patients received daily doses of 150 mg of CBD twice daily for 7 days prior to the bone marrow transplant and for 30 days after. The results indicated:
-No patients developed acute GVHD while being treated with CBD;
-The rates of grades 2-4 acute GVHD by day 100 were 12.1%, compared with 46% in a group of all 101 transplant recipients; and
-CBD was found to be safe and well tolerated
Source Kalytera website press release