Zelda Therapeutics Ltd (ASX:ZLD, FRA:G1G, OTCMKTS:ZLDAF) has enrolled a milestone 100th patient in a behavioural study evaluating its medicinal cannabis treatment in children on the autism spectrum.
The observational study at Children’s Hospital of Philadelphia (CHOP) now has 103 enrolled patients whose parents are reporting on the behavioural outcomes of cannabis treatments delivered in the study.
Kids in Zelda’s study are aged about 10 years old, diagnosed with autism and range in autism levels from classifications of low to medium or high-level severity.
A number of cannabis treatments are being trialled, one being THC-only, the other CBD-only or combinations of both — with a variety of dosings being studied.
Parents of the children are observing their kids’ behaviour for the study and are finding improvements.
The extent of the improvements depends on the type of treatment and dosings a child is administered.
Zelda managing director Dr Richard Hopkins reported today: “We’re very encouraged by the preliminary analysis of the data from this observational study.
“Results show that treatments with a range of cannabis medicines were associated with improvements in several key behavioural markers that are prominent in children diagnosed with autism.
“This highlights the potential for medicinal cannabis to improve outcomes for autistic children.”
Hopkins flagged the company believes its study is the first to report what he called “differences in autism severity based on responses to medicinal cannabis treatments.”
He said: “The ability to stratify patients according to various clinical criteria could help us better predict whether patients will be more likely to benefit from medicinal cannabis treatments.
“While these initial findings are encouraging, we need to be cautious interpreting the results from observational studies such as ours, where parent-reported data is used and where there is limited baseline information available prior to treatment, which can result in significant bias.”
To address the potential for bias that affects reported outcomes, Zelda hopes to design a randomised blinded trial of children with autism spectrum disorder later this year.
Hopkins told the market the company was well placed to be an early mover on medicinal cannabis as the pharmaceutical subsector was more regulated and prescription product requirements became more demanding clinically.