Zelira Therapeutics has published positive results from an observational trial of its Hope cannabinoid medicine for patients with autism spectrum disorder (ASD).
In November 2020, the company entered into an agreement with Emyria to provide it with longitudinal real-world data from 45 ASD patients prescribed a Hope product, generated from dispensing data and the observational trial.
A white paper analysis showed that almost 70% of patients were rated by clinicians as having achieved a moderate therapeutic effect after five months on the medication.
A total of 25 adverse events occurred in nine patients, although all were mild/transient with none deemed serious.
The mean age of patients was 14.1 years of age, with the youngest being 5.1 years.
Zelira managing director Dr Oludare Odumosu said: “Physicians and patients often ask for proof of the safety, efficacy, and dosing guidelines for cannabinoid-based medicines.
“Zelira is pleased to share the results from this longitudinal real-world trial because it provides prescribers with empirical information and additional confidence to prescribe Hope.
“These results provide additional clinical and regulatory validation for our products as we expand into highly regulated global markets.”
Hope was launched in Australia in October 2020 and is available under the Special Access and Authorised Prescriber schemes.