• Since TGA’s down-scheduling of CBD last year, no products have been sold in Australia
  • But the race to market has been seemingly won by Bod Science following a ‘landmark update’
  • Stockhead reached out to BOD’s CEO, Jo Patterson


Amidst growing global acceptance of medicinal cannabinoids, the Australian TGA down-scheduled low-dose cannabidiol (CBD) from a prescription medicine (Schedule 4), to a pharmacist-only medicine (Schedule 3) in 2022.

Under Schedule 3, CBD products can be purchased over-the-counter (OTC) at pharmacies without a prescription, as long as they’re below the allowed dosage of 150mg/day.

Since that announcement however, there have been no OTC CBD products approved for sale anywhere in the country.

Rigorous testing, long clinical trials, and regulatory hurdles have been the main reasons for the lack of products on shelves.

Some experts even blame the TGA, calling its decision a “red herring” since the rule requires all Schedule 3 medicines to first be registered on the Australian Register of Therapeutic Goods (ARTG) – a tall task given that efficacy is a primary requirement for approval.

“If the TGA sets the bar too high, sponsor companies may find it difficult to meet the efficacy requirements,” said Dr Vicki Kotsirilos, Australia’s first authorised prescriber of medicinal cannabis.

It’s indeed a hurdle that many companies have struggled to get over, but there is one company that has seemingly pulled away from the rest of the pack –  Bod Science (ASX:BOD).

Earlier this week, BOD announced a ‘landmark update’ after completing all patient dosing in its Phase IIB Can-Rest Insomnia trial – a milestone that has put the company in pole position to have the first Schedule 3 CBD product in the Australian market.


BOD ‘way ahead of nearest competitor’

Bod Science CEO, Jo Patterson, told Stockhead that in order to get ARTG registration, a company would have to undergo a ‘gold standard’ clinical trial, which is usually a double blinded placebo trial.

“The product obviously has to meet the specifications that the TGA has outlined for a low dose CBD product, and it also has to be for a specific indication,” said Patterson.

BOD’s insomnia trial has been two years in the planning, and at least 12 months in the making, recruiting 198 patients in total.

“And now we’re about to lock the database and analyse the top line results which will be ready around mid to late August.”

Patterson acknowledged there are other cannabis companies looking at the opportunity of bringing a Schedule 3 product to the market, but said they are still a long way behind BOD.

“Some are still waiting for ethics approval, while others have got ethics approval, but haven’t started recruiting. I’m not aware of any that have actually started a trial.

“So we are a long way ahead of the nearest competitor, and it gives us a good first mover advantage,” she said.

Globally, Patterson said that US-based Jazz Pharmaceuticals (GW Pharma) is the only company to have had a CBD product approved and registered with a regulator. (Jazz’s cannabis-derived epilepsy drug Epidiolex won its FDA approval back in 2018.)

“This means that BOD could be the second company globally to have a registration on a cannabis product, which is really exciting,” said Patterson.


At ‘tipping point’

BOD’s unique CBD formulation is presented in a unique soft gel format and utilises a patent protected encapsulation technology that improves the bioavailability of the CBD extract.

Under TGA requirements, the formulation needs to contain 98% pure CBD, which basically meant that CBD isolates had to be used.

When you read the ingredients of various CBD products, you’ll discover that many also contain MCT oil as the carrier oil. CBD and MCT are mixed because MCT oil improves the absorption of CBD in the body.

Patterson however said that CBD is very lipophilic, which means it’s not water soluble, and so you only get 8% to 10% of CBD into the bloodstream in that format.

“So what we’ve done is use our patented encapsulation technology, which binds with the CBD, in order to get more of the active CBD ingredients into the bloodstream compared to CBD in MCT oil.”

While the results of the trial will be available in August, Patterson said BOD won’t have to wait for the TGA to grant the registration to recognise value from all the work already done.

“So while that particular trial has been targeted for the Australian market, we can in the meantime take this body of work and look into commercialising it in other markets.”

Patterson added that as a company, BOD is now at the tipping point of commercialising all of its assets.

“’We’ve probably spent the last six years investing in different drug delivery technologies, and now, those technologies have been patented.

“This Schedule 3 trial is just one really good example of that. We have other products as well, including Aqua Phase, a drug delivery technology which has superior bioavailability and solubility.

“So BOD has done the heavy lifting, and now we’ve got these near term value catalysts,” said Patterson.


Cannabis stocks undertaking clinical trials

As Stockhead’s Emma Davies explained,   each cannabis stock on the ASX typically fits into one (or more) of the following categories:

  • Biotechs and pharmaceutical – These are companies that are focused on creating drugs and taking them through clinical trials. Two of the more prominent stocks in this space are Incannex (ASX:IHL) and Zelira (ASX:ZLD).
  • Growers – These companies grow cannabis plants and ship their produce to cannabis companies in other categories. Examples include Little Green Pharma (ASX:LGP) and Cann Group (ASX:CAN).
  • Hemp – Hemp is a specific variety of cannabis sativa grown specially for its fibre as well as for its low levels of THC. This category contains some of the most successful ASX pot stocks including ECS Botanics (ASX:ECS) and Elixinol Wellness (ASX:EXL).
  • Lifestyle – These companies create cannabis-based lifestyle products and sell these to the public. One example is Live Verdure (ASX:LV1).
  • Ancilliary – Cannabis is not their primary trade but are involved with the sector – perhaps having cannabis clients. An example is Roto-Gro (ASX:RGI) which makes vertical farming systems including for cannabis companies.


Below are the cannabis biotech stocks that are currently conducting clinical trials. It’s important to note that most of these trials were designed for FDA approval, instead of TGA.


Little Green Pharma (ASX:LGP)

LGP obtained an ethics approval for its proposed Australian-based, multi-site, placebo-controlled ‘SleepWell Study’ last November.

The study aims to demonstrate that its Classic CBD 50 cannabis oil medicine is effective on stress reduction, and improves quality of sleep in healthy adults.

There has been no further news on the study following that announcement.


Zelira Therapeutics (ASX:ZLD)

Zelira rocked the medical world last month when it said that it had come up with an alternative drug for diabetic nerve pain that performed better than Pfizer’s Lyrica.

The study showed that ZLT-L-007, a cannabinoid-based oral capsule, was safe and well-tolerated, meeting the primary endpoint for safety with no Serious Adverse Events (SAE).

The study also met its secondary endpoints, including significant decreases in Visual Analog Scale (VAS) and Short-form McGill scores, among others.

According to research, the global diabetes drug market was worth at least US$62 billion in 2022, and is projected to double by 2032.

As many as 50% of people with diabetes suffer from nerve pain, and half of all amputations annually are associated with the disease.

The studies were not designed for a TGA approval, instead Zelira said it will further progression of ZLT-L-007 into formal FDA clinical trials.


Incannex Healthcare (ASX:IHL)

Incannex has the world’s largest portfolio of patented medicinal cannabinoid drug formulations and psychedelic treatment protocols.

The company is placing a significant importance on the US market, given that it’s the largest pharmaceutical market in the world.

IHL has an upcoming pivotal (Phase-2/3) study of its novel cannabinoid combination for patients with obstructive sleep apnoea after promising Phase-II results were released last year.

Results found that IHL-42X reduced AHI (apnoea hypopnea index) by an average of 50.7% versus baseline assessments, and 25% of participants experienced greater than an 80% reduction in AHI measure.

Incannex is also on the move, with plans to redomicile its shares to the US on the Nasdaq exchange.


Emyria (ASX:EMD)

Emyria was granted a Human Research Ethics Committee (HREC) approval to commence a pivotal MDMA-assisted therapy trial for Post-Traumatic Stress Disorder (PTSD).

The study will be conducted at the PAX Centre, one of Australia’s leading psychiatric services specialising in the treatment of complex trauma.

Emyria says MDMA-assisted therapy has shown promising results for patients with PTSD.

The use of MDMA-based therapies to treat mental conditions has gained attention after the TGA allowed MDMA to be used on PTSD patients starting July 1.


Cannabis stocks on the ASX

Code Company Price % Year % Six Month % Month % Week Market Cap
VIT Vitura Health Ltd 0.55 175.00 -6.78 44.74 -3.51 $300,527,318
BOT Botanix Pharma Ltd 0.13 89.29 124.58 35.20 -1.85 $183,943,210
ALA Arovella Therapeutic 0.05 80.77 104.35 2.17 -6.00 $41,645,525
CTV Colortv Limited 0.01 33.33 0.00 0.00 0.00 $1,236,985
ECS ECS Botanics Holding 0.03 8.33 8.33 36.84 13.04 $28,774,997
RGI Roto-Gro Intl Ltd 0.22 0.00 0.00 0.00 0.00 $4,333,920
EVE EVE Health Group Ltd 0.00 0.00 0.00 0.00 0.00 $5,274,483
ZLD Zelira Therapeutics 1.51 -1.95 49.51 -11.70 -5.63 $17,361,147
AC8 Auscann Grp Hlgs Ltd 0.04 -9.09 0.00 0.00 0.00 $17,621,884
BOD BOD Science Ltd 0.09 -10.81 -32.31 87.23 -1.12 $13,780,934
WNX Wellnex Life Ltd 0.05 -17.19 -24.29 0.00 0.00 $22,203,352
CGB Cann Global Limited 0.02 -19.23 0.00 0.00 0.00 $5,436,345
DTZ Dotz Nano Ltd 0.24 -21.67 -9.62 -6.00 -6.00 $111,893,428
EOF Ecofibre Limited 0.18 -21.74 -32.08 -10.00 -2.70 $61,112,546
EPN Epsilon Healthcare 0.02 -30.30 0.00 15.00 15.00 $6,908,142
HGV Hygrovest Limited 0.04 -30.65 -38.57 -6.52 2.38 $8,622,735
NTI Neurotech Intl 0.05 -31.82 -35.71 12.50 12.50 $39,325,927
EMD Emyria Limited 0.13 -36.59 -23.53 0.00 -7.14 $40,085,411
LGP Little Green Pharma 0.20 -37.50 11.11 17.65 17.65 $56,880,745
WOA Wide Open Agricultur 0.33 -41.44 58.54 0.00 0.00 $46,566,576
MDC Medlab Clinical Ltd 6.60 -46.34 -4.76 0.00 0.00 $15,071,113
IRX Inhalerx Limited 0.04 -46.67 -33.33 -6.98 -6.98 $8,919,047
IHL Incannex Healthcare 0.11 -48.84 -40.54 4.76 0.00 $174,571,139
AGH Althea Group 0.05 -49.48 -23.44 8.89 16.67 $18,301,852
IDT IDT Australia Ltd 0.07 -50.37 -14.10 3.08 3.08 $21,320,838
LV1 Live Verdure Ltd 0.09 -51.43 -50.00 -37.04 -14.14 $7,967,351
RNO Rhinomed Ltd 0.06 -53.85 -45.45 -14.29 -13.04 $17,143,182
CAN Cann Group Ltd 0.13 -55.58 -36.07 -6.39 4.00 $50,458,832
AVE Avecho Biotech Ltd 0.01 -58.33 -61.54 -16.67 0.00 $12,972,982
EXL Elixinol Wellness 0.01 -59.38 -38.10 -13.33 0.00 $5,940,888
MXC Mgc Pharmaceuticals 0.01 -72.22 -54.55 -16.67 25.00 $16,753,465
BP8 Bph Global Ltd 0.00 -77.22 -77.22 -14.29 0.00 $4,004,189
ME1 Melodiol Glb Health 0.01 -85.00 -72.73 -33.33 -14.29 $18,819,876
ROO Roots Sustainable 0.00 -89.29 -75.00 -10.00 12.50 $554,889
WFL Wellfully Limited 0.00 -92.86 -73.33 -55.56 -20.00 $2,464,721
TSN The Sust Nutri Grp 0.01 -95.00 -70.83 -12.50 0.00 $985,340
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At Stockhead we tell it like it is. While Incannex Healthcare is a Stockhead advertiser, it did not sponsor this article.