Cannabis Meets Pharma: How Medlab is Taking Cannabinoid Therapies to New Heights
DATE: Wednesday 27th April 2022
Cannabis remains an emerging space, both in the U.S. and internationally. As prohibition measures have relaxed around the world, though, research has revealed new insights about the therapeutic potential of the plant. These findings have given rise to legal medicinal cannabis and compassionate use programs.
Still, despite clickbait headlines and marketing teams proclaiming cannabis as the cure-all of the day, there are significant limitations preventing botanically derived products from making the leap from therapeutic herb to pharmaceutical medicine. Today, as medicinal cannabis programs emerge and expand worldwide, many research organizations and companies are dedicated to bridging that gap to bring safe, effective, consistently replicable medicines based on the cannabinoids found in the plant.
We spoke with Dr. Sean Hall, MD, CEO of Medlab Clinical LTD, about these efforts and how his company is contributing to these efforts to take what we’ve learned about cannabis in recent history and translate it into the development of new clinical medications that are efficacious enough for doctors to prescribe to their most sensitive patients.
Q: By now most of us have heard about medical cannabis, but what is it that makes this plant effective?
A: Cannabis is a very special plant that contains these unique compounds known as cannabinoids, that’s your THC and CBD and so on. These compounds serve the plant in a variety of ways in nature, but what’s remarkable is they also interact with a system found in most vertebrates, including humans, known as the endogenous cannabinoid system (ECS). This system serves to regulate a wide range of functions governed by the central nervous system and immune system, from pain modulation to appetite to mood regulation and so on. We’ve really only just started to scratch the surface of how it all works together, but what we do know is that cannabinoids play a role in influencing this system.
That’s a really simplified explanation but, generally speaking, this is why cannabis has the ability to make people feel better, whether that is managing their pain, lessening their anxiety, or stimulating their appetite. However, it’s important to remember cannabis is rather dose-dependent – that is, just because it could be beneficial for reducing your anxiety doesn’t mean it will be at higher doses. The way people are consuming cannabis products isn’t always the best way to treat their symptoms. So, if we can learn from the way these cannabinoids interact with the ECS, and then create pharmaceutical medications to that end targeting those mechanisms of action, then we’re able to more accurately treat even severe symptoms associated with chronic illness or diseases.
Q: How is Medlab leveraging cannabinoids to develop medicine and what are the goals of your current programs?
A: First and foremost, we’re a biotech company, which means we’re playing with medicines. Our work is with regulatory bodies like the FDA because we’re building medicines. We have identified various types of clinical targets that today have significant unmet needs. Where our cannabinoid program differs is we work in areas of high validation from chemistry through to manufacturing and we are subject to rigorous clinical trials to establish that proof of efficacy.
We have two cannabinoid programs focused on CBD for stress management – we call it NanoCBD(™)– and one focused on a combination of THC and CBD for cancer bone pain, called NanaBis(™). We’ve worked with patient groups collecting data on pain, both cancer pain and non-cancer pain. We actually see that our best responding group is cancer patients with bone pain, and this is a group of patients that, when you meet them, you really feel for them. We’re also seeing promise in general cancer pain management as well. This would give doctors a pre-opioid option to treat pain in these patients, and we might see fewer patients progress to opioids. It’s interesting and exciting and the signals we’re getting from the data are really strong.
Then there are the mental health applications, which to us are just as big as the potential in oncology. The growth in occupational stress during the COVID-19 pandemic is really scary, and there’s no therapeutic option currently. It’s a growing concern and COVID-19 really showed how bad the problem is in terms of personal impacts, economic impacts, business impacts, impacts on relationships. There’s no approved medicine for it now, but it’s something we’re working on here.
Both of these programs use the same delivery platform, called NanoCelle(R), which allows us to take a molecule and make it a lot more efficient simply by getting it down to sub-micron particle size and significantly improving the solubility– we’re talking nanoparticles. It makes it as simple as small doses of an oral spray administered into the interior of the cheek (called buccal administration), which limits side effects and gets it into circulation super quickly; it takes about two minutes. By five minutes, we can measure its presence in the blood and around 50 minutes it’s at full effect, with a half-life of about four and a half hours – and that’s consistent batch to batch.
Q: Why use synthetic cannabinoids rather than botanical extracts?
A: On one hand, it’s great that there are these compassionate use programs here in Australia, or medicinal cannabis markets emerging in the U.S. and Europe. But, on the other hand, the therapeutic effects that can be derived from botanicals are very limited when it comes to the clinical environment. It might be good for your backache, for example, but when it comes to treating chronic pain in a clinical environment there’s just far too much variation between each plant and each batch of product to have a precise, consistent result. When it comes to pharmaceutical products, precision is absolutely critical, as it directly speaks to the validated quality
We started out working with botanicals, and our botanicals were 97% standardized with less than 8% inter batch variability. You have these error margins in pharmaceutical development and there are these differences batch to batch. But in pharmaceuticals, when you’re making a product, every batch needs to be exactly the same and the compounds used need to be better than 98% standardized under pharmaceutical processes. So, we partnered with a biosynthetic firm in the U.S. and we cracked that code and now have a neat CBD, zero margin for error 100% plant-identified, as well as a neat dronabinol, which is THC at 100%. As a result, we have what is called drug master files recognized at the FDA.
If we’re going to make a consistent medicine, the plant is really difficult to use. We’re talking about high-performance medicine. To have a drug master file means you’ve demonstrated that time and time and time and time again it’s the same, it’s consistent, and the quality of the product is there.
Q: What is Medlab doing to help advance cannabinoid research and improve the medical community’s understanding of the therapeutic potential?
A: We’re working on establishing clinical data in patient groups that have been in the program from 2 months to 12 months so we’re one of the few companies out there that are actually collecting long-term data. Right now, we’ve got 1,000 Australian patients under observation, and we can say that the risk profile of Nanabis(™) has less than a 9% adverse effect profile – that’s really good – and less than 1% of adverse reactions are serious and unexpected.
In this patient group, we’ve got people as young as 18 and many over the age of 65. The data is consistent, so there are no wild cards, and we’re building contra-indication with other treatments like chemo- frontline inhibitors. This gives us a sense of when to administer our program, when to halt it, and when to recommence.
Q: What lessons is Medlab taking from the successes of medicines like Epidiolex, as well as the failures of products like Sativex?
A: We really see delivery platforms (such as our NanoCelle(R)) as heightening medicines and their efficacy. In the past decade, the number of blockbuster products developed is just a fraction of what it used to be. During the pandemic, though, there was this run on COVID-19 and the development of vaccines and pills, but when was the last time you saw a blockbuster medication developed for cholesterol or insulin? There hasn’t been much, but now there is more of an emphasis on biotech to create on the innovative side.
Sativex failed with the FDA for a number of reasons, but one interesting reference was it was some60% standardized material – that means there’s a lot of room for variability. You need to eliminate those variabilities, and that’s what NanaBis™ is. But the secret sauce is our NanoCelle(R) platform because it allows small doses administered orally in a way that’s easy for the patient, heightened absorption and limits side effects.
About the author
Medlab in-house Editor.