Multi-clinic, open-label observational study into the effectiveness of its medicinal cannabis range, MediCabilis™.
Medicinal cannabis, CBD and hemp healthcare products
company, Bod Australia Limited (ASX: BDA) advises that it has commenced an Australia-wide, multi-clinic, open-label observational study into the effectiveness of its medicinal cannabis range, MediCabilis™, for indications including anxiety disorders, insomnia, and Post Traumatic Stress Disorder.
The study aims to collect data from 500 patients who will be prescribed MediCabilis™ over a 12-month period with the aim of generating insights into the efficacy of the product on patients suffering from particular conditions. The study builds on Bod's Phase I Clinical Study (refer ASX
announcement: 26 March 2019) and also supports research being undertaken as part of Project Twenty21, Europe's largest medicinal cannabis registry (refer ASX announcement: 8 November 2019). The results will provide important data to support practitioners who are prescribing MediCabilis™ and assist Bod in modeling its planned future research and product development.
The initiative will be run through approved study sites across Australia, with reputable partners including Cannabis Doctors Australia, Compass Clinics, Cannabis Access Clinics, and Tetra Health.
Bod anticipates that each patient will be prescribed MediCabilis™ three to four times over the course of the study, which will add to the Company's growing cannabis prescription sales pipeline. Further, the initiative will create additional visibility for the Company's product amongst healthcare professionals and patients.
Study design has been approved by the Bellberry ethics committee and will comply with Good Clinical Practice standards. Data will be collected using scientifically validated methods and an FDA and TGA-compliant database, which will support the registration pathway for MediCabilis™ in the USA and other markets.
First patients are currently being recruited and Bod expects to receive first prescriptions from the study this month. Bod will release data generated to healthcare professionals throughout the study, as well as provide ongoing updates on prescription volumes.
CEO Jo Patterson said: "We are confident that the outcomes from this extensive trial will provide important insights for medical practitioners into how MediCabilis™ can be best utilized for patients suffering from a number of chronic conditions and common, yet debilitating disorders.
"The need to find alternative solutions to treat a range of chronic health disorders is ever-present and we are hopeful that this trial will further demonstrate the effectiveness of MediCabilis™ in helping sufferers. The prevalence of these conditions amongst the global population is
considerable – up to 33.7% of people are affected by an anxiety disorder during their lifetime with up to 30% not responding to regular treatment. Conditions such as chronic insomnia also have a significant impact on a sufferer's health and can result in considerable healthcare costs iii.
"While MediCabilis™ uptake amongst patients and healthcare professionals continues to build, this study provides us with another sales channel and greater visibility in the Australian market. We look forward to updating shareholders on receipt of the first prescription and study progress in the coming weeks."
Bod's Chief Scientific Officer Dr. Adele Hosseini added: "One of the reasons doctors are hesitant to prescribe medicinal cannabis is because they do not feel there is sufficient high-quality evidence to support its safety and use. Bod is conducting this study to systematically collect validated, real-world data that will provide insight into how MediCabilis™ is being used
and build the evidence base that will boost both practitioner and patient confidence and trust in the medicines."
Cannabis Doctors Australia Principal Investigator Dr Ben Jansen said: "Bod is to be commended for taking a pharmaceutical and scientific approach in gathering high-quality evidence to guide and support the use of their medicines. Our clinic regularly prescribes Bod's medicinal cannabis medicines due to the results we are seeing in our patients and are pleased with the reliability of the medicines. Treatment is improving outcomes for many of our patients, many suffer from chronic conditions that haven't responded to conventional treatment options and have limited options. We are in full support of this national study and I am proud to be the primary investigator leading this important research."
If you are interested in finding out more about the trial or potentially participating, please visit www.bodaustralia.com
To learn more about Bod Australia, visit the company HQ here.
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