December 11th, 2020
Below is a transcript of the session.
Hello, everybody, and welcome to the first day of Prohibition Partners Live. It promises to be four days of super-interesting talks on the cannabis and psychedelics industry. I’m Conor O’Brien and I’m an analyst here at Prohibition Partners. Today, I’ll be talking about COVID and cannabinoid-drug development.
I will be touching on what kind of medicines we need for COVID at the moment, why cannabinoids might be a good option to treat the symptoms of COVID, where we’re at in the drug development process and developing cannabinoid-based drugs for COVID, and what this means for cannabinoids beyond the pandemic. To give an idea of the context, here are the vaccines we have for COVID-19. This is the pipeline as assessed by the World Health Organization this week. As you can see, there are tons of vaccines in the pipeline, over 150 in preclinical stages. But the real ones that we want to focus on are these eleven that are already at phase-3. So, this is kind of the last stage before being approved to treat COVID and before being marketed. So, these phase-3 trials would be large-scale studies in patients.
Possibly the best known so far are the candidates from Pfizer and BioNTech. So, there was news this week that their vaccine is 90% effective in preventing COVID infection. And we should see probably positive results from Moderna within another couple of weeks as well. Having said that, there are no approved vaccines yet, but we all expect that there will be soon. And this is obviously great news. We might ask the question then, “Do we still need COVID treatments?” And there are a few reasons why we might.
So, it will take a few years for vaccines to be fully distributed around the world. Part of this is that there are storage issues with vaccines. For example, the vaccine developed by Pfizer needs to be kept at -70° Celsius. So, this means that countries that don’t have that infrastructure will have to wait and build it out before they’re able to distribute the vaccine. And meanwhile, people will become infected inevitably and need treatment.
Another reason is that many people won’t take the vaccine. So, Gallup have surveyed the American people and 50% of those people said they wouldn’t accept a vaccine against COVID-19. So, this means that those patients will need treatment, but also anybody else who they infect potentially will need treatment.
And finally, there’s potential mutations of the virus. That means that we’ll need to continuously update our vaccines and treatments, and there’ll be vulnerable patients in the time lag between developing the new treatments, so… developing the new vaccines, sorry. So, all of this is to say that we will still need COVID-19 treatments for the foreseeable future.
This image should give an idea of how many treatments are in the pipeline at the moment. The FDA have reviewed over 370 treatments for COVID symptoms. 27 of these have reached phase-3 clinical trials. But only a few had been approved. You have 5 in the US at the moment that are approved for emergency use, and 1 which has full approval. So, with such a huge pipeline, you might ask, “Do we need cannabinoids in this fight against COVID?” And that is debatable, but again here are some reasons why we might.
Many drugs fail in clinical trials despite preliminarily positive evidence. So, it can never be a bad thing to have backups. Secondly, it will be good to have a range of treatments for COVID symptoms, especially for different stages or different phases of the disease. We might want 1 treatment or a range of treatments for mild conditions and a range of treatment for more chronic and of conditions. And, a reminder that the value of any COVID treatment that reduces hospitalization or reduces the need for ventilators will save thousands of lives just by virtue of more medical resources being kept available for those in chronic condition.
So, just to kind of give background as to why cannabinoids might be a good option for treating COVID symptoms, I’ll just look at the disease course of COVID. You could split the cases up into mild, severe, and critical. In mild cases, patients might just have a cough, or they might even be asymptomatic. But as the infection progresses, you would see a heavier infection in the lungs, they start to build up fluid, and body has this inflammatory response, which at the start is helpful, but eventually can start damaging the body’s own tissues.
Patients can then move into a critical condition where this overactive immune response, this inflammatory response spreads to the rest of the body. So, now you have all or several organs under inflammatory pressure, and they’re also oxygen-depleted at this point due to problems with the lungs. So, this is the stage where patients would really get into trouble and you could be looking at fatalities.
So why would cannabinoids be a good option at treating this? Well, they’re powerful anti-inflammatory agents, especially CBD. So, this could halt the progress of patients through the phases of the disease, and stop them before they move into the severe critical conditions. Also, there’s some preliminary evidence that cannabinoids can down regulate the amount of receptors on cells, which COVID specifically binds to to get into the cell. So, if you can stop that, then you could stop the proliferation of COVID throughout the body.
So, this is an overview of where we are in the drug development process for cannabinoids and COVID. We were able to identify 16 groups that are working on developing drugs in this field. So, 10 of them are at the preclinical stages. Half of those have positive results so far, which is good to see. But that just means that they’re positive in models of the disease, not in patients. So, that means there might be good evidence for treating COVID related symptoms in cells in dishes or in mice, for example. Just six projects have made it to the stage where they’re ready to treat patients, but none of these have produced results yet. The majority of the cannabinoids studies for COVID treatments are CBD-based. And there are a few that are using full strains of cannabis or THC or even novel cannabinoids.
So, here are the five groups which have reported positive preclinical trials. And we might share these slides after the talk. So, if anybody wants to have a closer look at these projects, you’re more than welcome to. These are the six groups which are potentially more of interest because they’re at the stage where they’re testing cannabinoid drugs for COVID symptoms in patients. And again, if you want to have a closer look, you can do so with the slides that we distribute afterwards. And we’ll just take a look at two of the particularly interesting studies.
So, this one from Cardiol Therapeutics, they have a relatively large patient population compared to the other studies that were mentioned above. So, 422 patients will be treated with Cardiol’s drug that’s being developed, which is a synthetic cannabidiol or CBD. And their aim is to reduce inflammatory damage, especially in the lungs. And this is specifically for those patients with cardiovascular disease or risk factors, so you know, heart and lung conditions going into having COVID. This study is being run in the University of San Paolo. So, they are investigating the use of natural CBD for COVID patients with mild to moderate symptoms. They have slightly less patients, about 50 patients are being treated. But they are further along in the development process. So, they have already treated many patients, and they are expecting to finish their studies before the end of the year. So, we can expect results from that study soon enough.
All of this is to say that we don’t quite yet have solid evidence to say that we’re going to be able to use cannabinoids for COVID symptoms. To be able to say that, we have to wait until these studies or maybe perhaps even larger studies with more patients show positive results.
But that isn’t the only way in which cannabinoids are being used during the pandemic. For example, people are using more medical cannabis. And this is especially true of people who use cannabis for mental health conditions. So, this is a survey of over 1000 people in America who use cannabis for medical reasons. And as you can see, there’s a lot more people either maintaining their current dose or using more. And the interpretation of the fact that this is especially true for mental health patients is that people are using cannabis to cope with increased anxiety during COVID.
So, there’s quite a good possibility that CBD could play a role in CBD or cannabis could play a role in managing anxiety during COVID. There are two specific studies looking at this. One is for frontline workers, and one is just for COVID-related anxiety in general. But again, we should wait until positive results are back from this before anybody kind of promotes the use of cannabinoids for COVID or for COVID and anxiety-related conditions.
Some people have already jumped the gun. So, this is the FDA’s page, which is specifically set up for CBD related misinformation around COVID. And as you can see, there are groups who have already been contacted about this. And it’s important to bear in mind that it’s not just patients that there’s disadvantages, but also the reputational damage that’s being done to the industry when false claims are widely circulated.
So, just to conclude, cannabinoids may well play a role in the treatment of COVID symptoms, but we still have to wait to large-scale human patient trials are completed before we can say that this is true or false. In the longer term though, those people that are developing cannabinoid drugs for COVID, they are benefiting from a wide range of COVID-related supports, which means companies are getting millions in grants to support their research efforts. And there are bolstered review processes, meaning that people or groups can get their treatments approved in a more efficient manner. And even if a group just gets their treatment approved for COVID, there’s an increased possibility that they’ll be able to get the treatment approved for other conditions even after the pandemic. So, this could really affect the kind of long-term trajectory of cannabinoid drug development.
And just another warning note before we finish is that there are possibilities that cannabinoids could even increase the risk to COVID patients. So, we really do need to wait for studies. CBD can suppress the immune system. So, while this might be good to reduce the overactive immune system, in a patient who needs their immune system to kick into gear, this is obviously an important thing that needs to be kept in balance. So that is basically the state of play for cannabinoids drug treatment for COVID-related symptoms. Thank you very much.