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Kingdom Therapeutics, a UK-Irish biotech company, has passed a ‘major milestone’ in its ambitious journey towards launching clinical trials into cannabis and Autism Spectrum Disorder (ASD)
The young company, KT-20610, announced in January that they had chosen the major Contract Research Organisation (CRO), Novotech, to carry out their Phase 1b/2a Clinical Trials on its Lead Product.
Kingdom is hoping that once its current funding cycle has been completed, and clinical trials begin, it will open up a new area for cannabinoid-based research. This includes not just the need to develop innovative treatments in ASD but also severe digestive issues such as gut hyperpermeability.
According to Professor Liz Shanahan of MEDCAN24, the co-founder and CEO told MEDCAN24, “Our studies on animals showed improvement in gut permeability. We also saw a reduction in inflammation in the gut and a decrease in inflammatory markers within brain tissue.”
The effects of cannabinoids are not limited to calming the brain and crossing blood-brain barriers. There is also a more profound physiological impact.
Kingdom Therapeutics
Kingdom was founded in 2019 by a ‘group of scientists and a father of a child with Autism’, with a foundational goal of addressing the need for more clinical research.
There are some promising reports that suggest cannabis can help people with autism. This is true for both children and adults. There is no clear answer to the question of what is an optimal ratio. CBD is not effective on its own, nor is a formulation with high THC or low CBD. “The current data are inconsistent”, Shanahan added.
This is where we began. We decided—perhaps naively, perhaps wisely—that the right thing to do was to conduct rigorous clinical research on cannabinoids to see if there’s more to it than just anecdotal evidence.”
The NHS has faced this problem for many years. Karin Smyth reiterated, in a recently-held parliamentary debate, that there was a need for further clinical research to improve access to patients.
Targeting eventual ‘full regulatory approval’ for its products in multiple markets, the company is now edging closer to launching its first clinical trials and is now in the midst of a funding round to cover the costly process.
According to Shanahan, Kingdom can conduct its studies with around £4m, but it is seeking around £10m to further extend its research.
“To be perfectly frank, there’s a lot more we want to accomplish—particularly our research on the gut microbiome and other areas that could bring immense value to the autism community, the cannabinoid research community, and the broader scientific field.”
Kingdom was able to secure some funding from Five Horizons Capital who had previously funded Argent Biopharma, formerly MGC Pharmaceuticals, to formulate its partnership with Novotech for the study.
Clinical trials
Kingdom had worked with Novotech during preliminary discussions with the Food and Drug Administration (FDA), in efforts to ‘gauge their comfort’ with Kingdom’s approach.
Celadon Pharmaceuticals is supplying both CBD and THC in purified form.
Kingdom has said that as part of the preclinical studies it conducted on mice, the company determined what the possible effective dosages and ratios would be for the research.
The transition from animal to human models is rarely straightforward. However, the current approved pharmaceuticals for autism were all created using this model. We are as confident in the pharmaceutical process as we can possibly be.
Initially, the human trials will be conducted with children and a ‘relatively low dose’ combining pure CBD and THC, but the company ‘plans to study adults at some point’.
Research will focus on behaviour improvements but also include gut health. Many children with Autism suffer from gastrointestinal issues, including gut hyperpermeability (commonly known as ‘leaky gut’).
Kingdom’s preliminary tests with mice showed improvements in gut permeability and reduced inflammation in the gut, as well as lower levels of inflammatory markers within the brain.
The key to our research, she said, is finding the optimal combination of cannabis for gut and brain effects.
It is also looking specifically at ‘child friendly’ formulations that would enable them to reduce the required doses of CBD and THC by increasing bioavailability, thus mitigating the side effects from other cannabinoid drugs like Epidyolex which uses very high doses.
Autism itself is not a single condition—it’s a broad spectrum, and each child is different. We believe that there are certain cohorts of children with specific symptom profiles, who could be good candidates for this study.
We hope to commence clinical trials as soon as our funding is completed. We’d love to see that happen today, but we understand it could take some time.