The race to the S3 schedule market has been seemingly won by Bod Science following a 'landmark update'. Picture Getty
Health & Biotech
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 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.
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.
As Stockhead’s Emma Davies explained, each cannabis stock on the ASX typically fits into one (or more) of the following categories:
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.
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 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 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 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.
| 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 |
At Stockhead we tell it like it is. While Incannex Healthcare is a Stockhead advertiser, it did not sponsor this article.
Health & Biotech
Health & Biotech
Health & Biotech
Get the latest Stockhead news delivered free to your inbox.
