First CBD trial on PTSD to drive research and NPD for Bod Australia's nutraceutical arm
The observational trial will not only potentially open up a new area of treatment and supplementation for PTSD sufferers, but may also help to drive Bod's plans to diversify MediCabilis' applications for both nutraceutical and pharmaceutical uses.
To be conducted jointly by Bod, contract research organisation Applied Cannabis Research, and medical centre Cannabis Access Clinics, the nationwide trial will involve 300 male and female participants above the age of 18.
Each participant will be administered a daily dose of CBD isolate, a non-psychoactive oil-based tincture — in this case, the isolate will be provided by Bod in the form of its MediCabilis oil.
The frequency and dosage of MediCabilis each participant will receive will depend on what his or her doctor prescribes, according to individual symptoms and other relevant factors.
These participants will include veterans and active servicemen and women (among others) whose PTSD symptoms have not been successfully treated via the pharmaceutical route.
According to lead researcher Dr Sharron Davis, traditional treatments had been found to be ineffective in addressing the symptoms of PTSD, which vary greatly; this has made it difficult to pinpoint a specific treatment that works for PTSD sufferers in general.
However, cannabis has been in the spotlight of late for its purported ability to effectively treat PTSD, which affects an estimated one million Australians every year.
Furthermore, cannabis is said to have no negative side effects, unlike more common pharmaceutical treatments.
The trial has received approval from the Therapeutic Goods Administration (TGA), and has already attracted overwhelming response from potential participants.
Speaking to NutraIngredients-Asia, Bod CEO Jo Patterson said: "We're recruiting anyone who suffers from PTSD, which does tend to be more common among veterans and servicemen and women, all of whom have shown interest in participating.
"We've had over 500 enquiries since we announced the trial, so now it's just a matter of narrowing them down to 300 through our screening process.
"This observational trial will help us compile data that can assist in conducting clinical trials in future. The entire trial will last 12 months, but each participant is only required to take MediCabilis for about four to five weeks."
She added that while the data would be collected over the four to five weeks during which the participants would be supplemented, they could choose to continue the treatment for longer.
Apart from potentially providing evidence for the basis of alternative PTSD treatment, the trial holds considerable promise for Bod’s plans in the European market
The company has had its ingredients and products GMP-certified in the EU, and has been in talks with local partners in Switzerland, Germany and the UK to sell MediCabilis both as a prescription pharmaceutical and an over-the-counter nutraceutical in these markets.
Considering the stricter laws in its domestic market, where cannabis is permitted for use only as a prescription medicine via the Special Access Scheme (SAS), the firm has seized more lucrative opportunities in Europe, where the laws surrounding medicinal cannabis in both the pharmaceutical and nutraceutical categories are more lenient.
Earlier this year, Bod signed a deal with Belgian natural medicine manufacturer Tilman to distribute both NutraCabilis — its soft-gel capsule range of supplements — and MediCabilis in pharmacies and specialty retailers in Belgium and Luxembourg.
The company is also planning to use its patented MediCabilis extract, ECs315, in a line of new products it is currently developing.
Patterson said, "ECs315 can be used in oils, powders and liquids, so we have a whole suite of items that will use the extract in all its different forms for different over-the-counter products.
"Very shortly, we will have soft-gel capsule supplements and sublingual wafers, as well as tinctures that are similar to the MediCabilis oil but come in a variety of concentrations. We are working on lots of different product applications, dosages and formats for the nutraceutical market."
Apprehensive about APAC
When it comes to the APAC market, however, Bod remains apprehensive, preferring to take a more cautious approach due to regulatory uncertainty.
"We haven't yet been able to get a definitive view on China or other Asian markets like Japan, but certainly, once we are able to and once they open up further, we would be interested in exploring them as options."
Still, Patterson is confident that when the time comes, Bod should have little to no problem entering the Asian markets.
"The good thing is that it would be easier to enter new markets as our products are already GMP-certified in Europe, which many other CBD supplement companies don't offer.
"We've also invested significantly in our Phase I clinical trial for MediCabilis, so there's plenty of safety data behind our products.
“This gives consumers and doctors great confidence, whether you're talking about a nutraceutical or prescription product."