Hello, and very good morning. You are watching Proactive London and up next here on the program, we are joined by Dr. Malcolm Barratt-Johnson the Chief Medical Officer from Albert lab. You’re joining us after announcing recent guidance provided by the UK Medicines and Healthcare product Regulatory Agency, otherwise known as the MHRA, supporting the company’s strategy to use the Real-World evidence approach for regulatory approval. So we’re going to talk about that in lots of detail. So a warm welcome to you Malcolm.
Thank you very much, Katie. Good morning to you.
So how does the MHRA guidance on real-world evidence and data support Albert lab’s investigation of psilocybin assisted psychotherapy?
Well, the guidance came out on the 16th of December last year. It was very widely known that the MHRA is looking at this and we’ve known it within Albert Labs for about last year or two it’s it’s very interesting guidance it’s based on the work that MHRA has been doing over the last 10, 15 years.
When you’re looking at a new drug it is based on the safety, efficacy, and quantity of drug safety and efficacy. Certainly, certainly up to this point, it’s been based on the randomized clinical trial approach, which is the standard way that you look at a drug, you compare one arm against another arm and use that to see really whether it’s an advantage.
Now, it’s not that we’re looking at anything different from that. We aren’t taking an OCT approach, but we’re looking at this because silicide had been, and the psychedelics have been very well known for a very long period. Their use has been at the forefront of a lot of stuff last 20, 30, 40 years.
We know what the safety of these compounds is in terms of, their use, in the community. And we’ve also got a lot of data on that, but we don’t know though. Is in a scientific setting, how to examine these. Now, what the MHRA has done by this advice, they’ve laid out a way that you can look at data from patients in a trial, which is ongoing in real-time through Real-World Evidence.
So we’re looking at depression and anxiety in cancer patients. We haven’t looked to this area very much over the last 20, 30 years because of the infraction of a lot of the antidepressants within this group of patients in cancer, patients with psilocybin, we can look at this group because they don’t interact with the cancer drugs.
Now, in terms of the evidence itself and the way the MHRA has set out this guidance. In terms of actually approving the drug, psilocybin, we’re developing it allows us to take that further much quicker. Now we knew that the MHRA was on our side in terms of that. The MHRA would never approve a certain medicine, in terms of before we get licensed, it would never say to a company, ” you’ve got the green light”. But what it has said now is that the approach we’re taking, looking at patients in real-time, is one that we can carry forward in our clinical trials. We’ve got a very accelerated program, which I think is quite interesting to a lot of people, because I think, well, you can’t just take a clinical trial immediately and then get a license at the end of either this year or the beginning of 2023 that quick. It’s not something we sadly see in other companies, but we can do it if we’re looking at patients in real-time in the setting in which they’re being treated. That means we can get the efficacy and quality and the safety data much, much sooner.
This builds on the way that we’ve been looking at medicines. As I said, those last 20 years from a regulatory standpoint, it’s developed a lot. We’ve got a lot more techniques on board on the regulatory side, and we can see the way that this happens if you’ve got a good cohort of patients. The MHRA is supporting us in that and is exactly the right time to have this. So it’s, it’s a brilliant, brilliant thing to be seeing.
How would you describe your experience working with the MHRA and how has that maybe influenced your clinical approach?
Well, I’m an ex regulator. I used to work with MHRA extensively over the late nineties as a licensing assessor. And I also headed up the medical side when it first came in on the clinical trial side. Clinical trials were not licensed or approved by any agency, surprisingly in 2005, it was only in 2005 that we saw the regulators come on board.
Not only in this country but across Europe. And that experience has allowed me to see it from a much more general point of view. And when Albert Labs started running a clinical trial program, we looked at the way that the data have been presented or would be presented. And I looked at it and I said, there may be a quicker way of looking at it. There may be a way of taking the evidence and speeding the accelerator program.
So not only that, but it’s also the way that the MHRA has recently taken on board the Brexit process. It has allowed the MHRA, as we saw with their work on the vaccine programs to develop an independent way of thinking.
From the beginning of 2021, we saw that they developed things like ILAP, which is an innovative access program. Now, this allowed companies to take forward things much quicker on a regulator basis. It allows them to take data independently in the UK and work with it. We saw some of this to some extent when we got some of the negativity, could I say from the Germans or maybe the French regulators with the vaccine?
And they said, well, how can the MHRA, how can the UK do this before anybody else? This important was because of this. The MHRA took a very, very brave decision together with the government. They said, we want to make the UK, the center of research globally, we’re going to look at innovative methods of licensing and regulating.
ILAP allows you to work with the regulators on things like real-world data and real-world evidence to develop that quicker. So the MHRA will look at areas of concern such as cancer depression and anxiety, which has over a million patients in the UK.
There’s a huge number Katie and I think people don’t realize this is a group of patients that haven’t been treated. As I said before, when you got an area of need, then the MHRA will work with NICE, which is the market access group within the UK they are the ones that work out pricing as you know. The Scottish Medicines Consortium, which is the Scottish version of NICE, and the NHSE, which is the NHS executive to develop these medicines with you or to help and advise you how to get the regulatory process done quicker.
I think to some extent that’s what’s influenced a lot of my thinking about this and indeed influence a company over the last year or two. There’s a way of doing this in the UK now, but labs were originally set up on the Canadian side, out of Vancouver.
We’ve now got centers in Portugal and Manchester, but we set up our research in the UK because of this, we feel very much the UK is heading up research, is looking at innovative ways of looking at licensing and research. The route we’re taking will be the route that I think many companies will take in the future.
Does this new guidance change anything for Albert Labs?
No, not really because we sat out at the initial stages of development that we would take this route. We’d go down this real-world evidence real-world data route because we knew that that’s what would be coming down the line. Because we knew what the safety of the drug was in terms of generalities. You can never specify in a patient group, what the safety will be. But as I said before, we know quite clearly that this drug will not have massive safety effects in the limited dosing we’re giving. This is maybe one or two doses, which is ridiculous when you think of it compared to taking antidepressants for many, many weeks.
And this is what we believe will be a treatment breakthrough. Now you can’t promise anything. And I’m not saying that a license would categorically state one or two, but that’s our hope. And so it won’t change what our development route will be. It won’t change the timing particularly.
The guidance will allow the MHRA to think about the way that when we work with them, they will say, okay, well, this is something that we’re already on board with. And it would help the UK to develop that research and data background, which the UK government wants to be part of. We really, very much want to be part of that too.
We want to be seen as groundbreaking. Within the UK in an area where we can help a huge number of patients take Katie. And we can see that obviously from the condition side as well.
And that’s ultimately what it’s all about. Isn’t it. So thank you very much, indeed for coming. Dr. Malcolm Barratt- Johnson, the Chief Medical Officer from Albert Labs.
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