Bod Australia has been given the go-ahead by UK regulators to test the efficacy of its Medicabilis product in treating the long-term impact of Covid-19 (long-Covid).
The Sydney-based firm has secured authorisation from the UK’s Medicines & Healthcare Products Regulatory Agency to begin an open-label clinical trial led by principal investigator Dr Elizabeth Iverson, in association with Drug Science UK.
A trial protocol has been finalised, ethics approval secured and patient recruitment is underway, with plans to enlist up to 30 participants over the age of 18 suffering from long-covid.
Recruits will be administered MediCabilis on a daily basis over a six-month period and undertake monthly and daily self-reporting of common long-Covid symptoms via a smartphone app.
Long-Covid is an emerging condition referring to persistent or new symptoms that develop at least eight weeks following an initial Covid-19 infection. Symptoms include shortness of breath, fatigue, worsening chest discomfort, loss of concentration, chronic pain, anxiety and insomnia.
Bod said if successful, the initiative will unlock a large market opportunity, with the Office for National Statistics estimating 1.3 million people in the UK currently suffer from the condition.
CEO Jo Patterson added: “While there aren’t any existing treatments for long-Covid, our medicinal cannabis products have been used to treat and alleviate a number of similar conditions.
“We anticipate this clinical trial will provide us with great insight into its potential to treat long-Covid and build on the body of evidence for the use of cannabis-based medicines in place of other pharmaceuticals.
“We will utilise the data generated to gain a better understanding of whether MediCabilis can be used as a potential treatment and how we can expedite further product commercialisation, which will underpin ongoing sales growth.”
Drug Science UK was founded in 2010 by Professor David Nutt as a charity focused on providing an evidence base for sensible and effective drug laws, free from political and commercial influence.
Professor Nutt said: “Long-Covid shares symptoms with disorders that medical cannabis has been proved to treat. So this new study could be an exciting and important step for both patients and for our wider understanding of these medicines.”