Bod Australia is to start a clinical trial of its medicinal cannabis product, MediCabilis 5%, to treat long Covid-19 after the UK Medicines and Healthcare Products Regulatory Agency (MHRA) granted the company a clinical trial authorisation (CTA).
The six-month open-label trial analysing MediCabilis will be carried out in collaboration with Drug Science UK.
Bod Australia noted that the authorisation comes after a study protocol was finalised and obtained ethics approval from the Yorkshire Research Ethics Committee, Health Research Authority.
Currently, subject recruitment is underway with plans to enrol up to 30 patients aged over 18 years with long Covid-19.
In the trial, subjects will be given MediCabilis daily for six months.
Furthermore, each patient will need to self-report daily and monthly through a smartphone application to analyse common long Covid-19 symptoms such as fatigue, breathlessness, cognition, and pain.
The combined data will establish the feasibility and safety of medicinal cannabis and MediCabilis to treat the condition.
Bod Australia CEO Jo Patterson said: “While there aren’t any existing treatments for long Covid-19, our medicinal cannabis products have been used to treat and alleviate a number of similar conditions.
“We anticipate that this clinical trial will provide us with great insight into its potential to treat long Covid-19 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.”
MediCabilis is currently used to treat conditions such as anxiety, chronic pain, and sleep disorders, which are also common in long Covid-19 patients.
An emerging condition, long Covid-19 refers to continued or new symptoms that appear a minimum of eight weeks after the initial infection.
Bod Australia concluded the Phase I trial design for its pharmaceutical-grade cannabis extract in combination with a new delivery system, in August 2017.