Zelda Therapeutics (ASX: ZLD) has gained Institutional Review Board approval to trial its cannabinoid-based formulations on children suffering from autism, which was the final regulatory hurdle to jump before beginning the study.
The trial will be carried out at the Children’s Hospital of Philadelphia and involves observation and bioanalytical studies.
“We are very excited to be formally commencing this study in the US working alongside the Children’s Hospital of Philadelphia,” Zelda executive chairman Harry Karelis said.
“The high-calibre of Children’s Hospital of Philadelphia researchers and clinicians coupled with access to extensive infrastructure positions this study to be one of the first formal, robust studies of its type conducted to-date,” Mr Karelis added.
Autistic children will be treated with cannabinoid-based formulations and monitored for changes in disposition.
This will be done in conjunction with bioanalytical studies and will assist researchers in identifying the efficacy and safety of different compounds.
“Positive results will allow Zelda to potentially expand into a formal clinical trial to study the efficacy of standardised, high quality medicines,” Mr Karelis said.
He added the study will be carried out in parallel with a similar one in Chile.
Earlier cannabis studies on paediatric autism
Both the US-based and Chile-based paediatric autism studies will build on earlier observational trials undertaken in Chile, which yielded positive results.
Dr Gisela Kuester managed the previous study which included 21 children diagnosed with autism. The children’s average age was nine years and 10 months.
The Chilean study was conducted over 12 weeks and included metabolic and genetics testing as well as electroencephalogram and neuropsychological analysis.
Cannabis extracts were found more effective than conventional treatments in more than 70% of the children treated.
The study also improved at least one core symptom in 66.7% of the children.
Preliminary results from the US and new Chilean studies are anticipated in six months.
Shares in Zelda were unchanged at A$0.105 by late morning trade.