On Monday, August 26, 2019, pioneer of CBD therapeutics, Kalytera Therapeutics has announced that its Phase 2 clinical trials, designed to understand the effects of its CBD product on preventing acute graft versus host disease (GVHD) has resulted in a significant improvement, as per TMX Money.
The interim results supposedly allowed the firm to move on to Phase 3 rather than conducting more assessments through high dose cohorts. The entirety of the GCP-compliant study is a big milestone for Kalytera Therapeutics, as it has been receiving advice and input from the U.S. Food and Drug Administration.
The key focus of the study rests “on the most difficult of all patients at risk for acute GVHD,” and this includes individuals who are receiving bone marrow transplants from unknown donors.
According to the claims made,
“the level of disease is profoundly significant,” when the donor in not related to them – increasing one’s likelihood to die, especially “with grades 3 and 4 acute GVHD […] within the first several months […] greater than 70%.”
Interestingly, it was found that 1 in 12 patients in the low dose cohorts experienced acute GVHD at grades 2 to 4, with no patients developing the disease under the medium dose cohort. Speaking regarding the results is the CEO of Kalytera, Robert Farrell, who shared how pleased he was with the results.
He further shared that the team “did not expect the results from the low dose cohort to be as positive as they were,” adding that now they, “have interim results from the medium dose cohort that are equally as good.”
Farrell elaborated more on the whole jumping a step process, stressing that the reason for moving onto Phase 3 stems from the fact that the results from the medium and lose dose cohorts exceeded their expectations, combined with two previous clinical studies depicting similar results. This means that they will not move forward with the high dose cohort.
The 12-month long, Phase 3 trial will include 50 participants; 25 receiving the drug and the remaining ingesting a placebo. Everyone will be delivered a dosage of 150mg of CBD or placebo twice daily over the course of 100 days. The study will be randomized, double blinded and will be initiated in research sites in both Israel and Australia, which is the very same location in which Phase 2 was completed.
Given that Epidiolex is the first ever FDA-approved CBD product, results from Phase 3 of Kalytera Therapeutics’ study could make it the second to make the cut!