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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)
In January, the young company announced that it had selected major contract research organisation (CRO) company Novotech to conduct its Phase 1b/2a clinical trials into its lead product, KT-20610.
Once its current funding round is completed and the clinical trials can begin Kingdom hopes to open the door to a relatively untouched area of cannabinoid research, focusing not only on the urgent need for innovative therapies in ASD, but also on severe gastrointestinal issues like gut hyperpermeability.
Its Co-Founder and CEO, Professor Liz Shanahan, told Business of Cannabis: “Our animal studies showed improvements in gut permeability, reduced gut inflammation, and lower inflammatory markers in the brain.
“This suggests that the effects of cannabinoids go beyond just crossing the blood-brain barrier and calming individuals; there is a deeper physiological impact at play.”
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.
“Right now, there are promising stories suggesting that cannabis has an effect on individuals with autism, whether children or adults. But there’s no clarity on the optimal ratio, whether CBD alone is effective, or whether a high-THC or low-CBD formulation is necessary. The current data is too inconsistent,” Shanahan continued.
“That’s where we started. 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.”
This has long been a major barrier to the expansion of medical cannabis treatments on the NHS. In a recently held parliamentary debate on medical cannabis access, the new Minister of State at the Department of Health and Social Care, Karin Smyth, reiterated the need for more clinical research before any improvement of access for patients could be implemented.
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.”
With some initial funding secured from Five Horizons Capital, which has funded Argent Biopharma (previously MGC Pharmaceuticals) previously, Kingdom has been able to formalise its partnership with Novotech to conduct its 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.
The clinical trials, which are set to be conducted in Australia, will focus on two key active components, purified forms of CBD and THC, both of which are being supplied by Celadon Pharmaceuticals.
As part of its preclinical research into mice, Kingdom says it has determined the potential effective doses and ratios for the study.
“Translating from animal models to humans is never straightforward, but the currently approved autism-related pharmaceutical products were all developed using this model. So, as far as pharmaceutical development goes, we’re as confident as one can be in such a complex process.”
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’.
Its research will be focused on behavioural improvements, but will also extend to gut health. Many children with Autism suffer from gastrointestinal issues, including gut hyperpermeability (commonly known as ‘leaky gut’).
During its preliminary testing with mice, Kingdom was able to show improvements in gut permeability, reduced gut inflammation, and lower inflammatory markers in the brain.
“A key part of our research is determining the right combination of cannabinoids for both gut and neurological effects,” she continued.
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. However, we believe there are specific cohorts with particular symptom profiles who would be the right candidates for our study.
“We hope to begin clinical trials soon, once our funding round is fully completed. Of course, we’d like that to happen tomorrow, but given current market conditions, we know it may take some time.”
“}]] 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) Read More
