Gb Sciences – a leading plant-inspired biopharmaceutical research and development company – is beginning a dosage study of its plant-based, patent-protected formulations in a rodent model of Parkinson’s disease, the second-most common neurodegenerative disease.
The biopharmaceutical research company plans to file an Investigational New Drug Application to begin first-in-human clinical trials as early as next year when they will hire a new doctor-patient management service.
DocWire News spoke with Dr. Andrea Small-Howard, President and Chief Science Officer of Gb Sciences, about the company and this exciting news.
DocWire News: Can you give us some background on yourself, and the company, GB Sciences?
Dr. Andrea Small-Howard: Sure. Yeah. I’m a biochemist by training, which gives me a sort of an interesting perspective on the world. I’ve always been sort of fascinated by plant-based compounds.
And so back in the early 2000’s, I started looking at the effects of cannabis on the immune system, because I felt like that was a really important thing to be studying because at the time there were only five states that were allowing HIV and AIDS patients to have access to medical cannabis as sort of a part of a compassionate use program. Yet we had no information about what effects those compounds were going to have on their immune system.
So that was my first taste of really getting involved in using cannabinoids in a potentially medicinal setting. But I got to report back that it was really tough going in that when you were studying cannabinoids back in the early 2000’s, you had to do this DEA, NIDA, NIH shuffle.
There’s all this paperwork involved and it was really, really great work, but it was so hard to just get a single experiment done that eventually I started working in a different company where we were studying cancer and we had a great time developing new cancer therapeutics as well as new cancer testing methods.
And so that was a lot of fun, but I always wanted to go back and look at the power of plant-based medicine. So that’s kind of who I am, but it also leads us into how I got involved with GB Sciences.
So GB Sciences in the early days was a company that was looking to use science to enhance the way that patients were able to interact with medical cannabis. And we had two licenses, one in Las Vegas, and one in partnership with LSU in Louisiana. And so the goal was to take the power of science to better bring products to cannabis patients.
And so that was kind of how I got involved with GP Sciences as one of the founders. Since then, we’ve done a pivot and we’ve sold off all of our plant-touching assets. And during the process of us being a plant-touching company, we had access to the plant so we could do a lot of great research, much more quickly and easily than I could do if I was in an academic setting because I didn’t have to fill out a lot of new paperwork.
And so the learning that we had on how the plant works and how those compounds worked was really greatly accelerated while GB Sciences was a plant-touching company. And we took that information and we filed 60 patents on different uses of ingredients from cannabis as therapeutic medicines. And now we’re working on other plant-based medicines.
What are the main challenges associated with treating Parkinson’s disease?
The trickiest part of treating Parkinson’s disease is that it’s a multifactorial disease. Meaning there’s many different factors involved in getting it and it’s progression. And therefore it’s not like you have to fix one thing. Usually there’s a genetic component, but there’s also environmental things that happen that lead people into a diagnosis of the symptoms of Parkinson’s.
And so every individual patient has a different path towards the disease. And as they’re progressing through the disease, it’s also very individualized. The time course on the symptoms and stuff like that is very different depending upon the patient. And so you really need to take sort of a personalized medicine approach when you’re treating Parkinson’s disease.
Can you speak on the plant-based formulations GB Sciences has designed to treat PD?
Yes. So one of the overarching goals of our drug development program at GB Sciences is we are looking to create something we call Minimum Essential Mixtures. So we’re taking plant extracts, which contain literally hundreds of potential active ingredients, and we’re using an AI enabled drug discovery engine, as well as cell and animal models of disease to be able to determine how to simplify these mixture of a hundred different things down to something that usually has between three and five ingredients.
And we go through rigorous testing to make sure that we’re preserving the best parts of the activity of an original extract, but in a formulation that is much more readily adaptable to being produced in a factory. Does that make sense?
Talk to us about the recent news that GB Sciences’ formulation is entering final stages for first-in-human testing.
Yes, absolutely. We’re really excited. We’ve been working on this a while and things are coming together now. So one of the things that is also a challenge in working with, we’re calling them plant inspired ingredients because we do natural product research, but then the active ingredients that we’ve identified are being manufactured in a factory without the use of the plant.
So this is called a synthetic homolog and that’s, that’s kind of, I’m just going to get sciencey for a second here, synthetic homologs are identical in their chemical structure to what’s in the plant, but you can make it in these big vats in a factory with the precision that not only patients deserve, but also the FDA likes because all of our therapeutics are designed to go to the prescription drug market. And therefore we have certain standards of quality control and testing that we have to meet in order to be able to get these out to patients.
When do you expect human testing to begin, and what results are you hoping to see?
So, as I mentioned before, the active ingredients that we’re using in these mixtures for Parkinson’s, we’ve dialed it into not just what’s in there, but also the very specific ratios that are required for this to be used as a therapeutic in the cell and animal models.
We’re then combining the active ingredients in a tablet that’s an oral dissolving tablet. And that’s super important because if you can’t get these plant-based compounds into your system in an efficient way, then they’re not very good as medicine.
And the other thing that we did, when we were looking for a delivery method for active ingredients, is we thought about the patient population. And one of the things that’s known is that greater than 50% of all Parkinson’s patients really can’t swallow, not even water. And so we’re putting the active ingredients into something called an oral dissolving tablet in conjunction with a company called Catalent Pharma. They own the proprietary delivery rights.
So they’re putting those active ingredients that we’re providing into these tablets and the nice thing is that it’s going really well. So this sort of blending of putting the plant inspired ingredients into these tablets is going well. And so we’re now testing them to determine, based on animal studies, what’s the approximate dosage that you would need for human studies. And we’re also looking to see how often do you have to dose them to keep the levels of the active ingredients at the same level in their system, so that it’s effective?
So it’s very exciting to be in this final push to get, now that we’ve got the active ingredients identified, we’ve got them into these tablets, and now we’re doing the testing to verify that we know exactly how much and over what time courses to use.
So those are the things that are happening right now. So we’re right on that cusp of being able to file is something called an IND or Investigational New Drug Application so that we can start this trial. So we’re predicting next year.
What impact can GB Sciences have on the fight against neurodegenerative diseases such as PD?
We hope to have a significant impact in that we’re one of the few companies that is really thinking about using a multi component drug. And as I mentioned earlier, one of the frustrating things about Parkinson’s when you start to look at it, is that there’s several different aspects of the disease. There’s sort of an anti-inflammatory aspect, there’s a lysosomal dysfunction aspect of it. And so what we’re doing in our multi-component drug is we’re really trying to have ingredients in there that will address several of the different factors that leads to the disease.
And at this point, it’s being designed specifically to help with the motor symptoms of Parkinson’s, but we believe that testing will bear out that it may have some other activities.