The Board of Zelda Therapeutics (ASX: ZLD) has sponsored an observation autism trial in Chile, demonstrating successful results for treating the core symptoms of autism with medicinal cannabis extracts that Zelda is planning on taking into clinical trials.
- Zelda sponsored observational trial delivers successful results in treating symptoms of autism.
- Results demonstrate cannabis extracts were more effective than conventional autism medicines with 71.4% of cannabis treated patients improving in at least one core symptom area and 66.7% of patients treated showing significant overall improvement.
- Trial results presented at the prestigious 23rd World Congress of Neurology in Japan.
- Significant progress made on a submission for ethics approval for a clinical autism trial in Chile.
- Successful results will lead to product registration in Chile and potentially access to the wider South American market.
The results demonstrated that in a cohort of 21 patients (median age of 9 years 10 months), cannabis extracts were significantly more effective than conventional medicines used, including atypical antipsychotics, and these extracts were well tolerated by the patients overall.
Patients in the study were treated over at least a 12-week period and were examined by electroencephalogram (EEG), neuropsychological analysis as well as metabolism and genetic tests. The patients in the study had not responded well to conventional treatments. Patients treated with cannabis extracts demonstrated significant improvements in at least one core symptom including social interaction, language or repetitive behaviors in 71.4% of cases and 66.7% of treated patients showing significant general overall improvement.
The results are being presented at the prestigious 23rd World Congress of Neurology in Kyoto, Japan on 16 – 21 September 2017.
The trial was managed by leading clinician Dr Gisela Kuester who is a highly regarded neurologist specialising in the diagnosis and treatment of autism. She also holds the position of Clinical Research Director at Fundación Daya.
Zelda has previously announced its strategic alliance with Chilean non-profit patient advocate group Fundación Daya, to leverage their patient data on using cannabinoid-based therapy to treat autism patients. The results from this observation trial will assist Zelda in the development of its autism clinical trial. A submission for ethics approval is being finalized and is expected to be submitted in coming weeks.
Zelda expects the trial will commence within 3 months of regulatory approvals being obtained and will be conducted over a six to nine-month period.
Successful clinical trial results will enable Zelda to immediately commence the product registration process to sell approved products in the Chilean market.
Executive Chairman Harry Karelis stated:
“The results from this observational study are very exciting and supports the anecdotal evidence we have, showing the positive effect medicinal cannabis has on treating autism symptoms.
Zelda will use this baseline data to design its clinical trials and generate rigorous scientific data that validates the clinical benefit of medicinal cannabis.
We hope that in the near future Zelda Therapeutics can provide an alternative treatment for sufferers of this condition which is of major global significance.”