Rich McCormick: Hi, I’m Rich McCormick, the Executive Vice President of Clinical Strategy here at Vial. Today, I have the pleasure of welcoming Simon Allen, the CEO of Anebulo Pharmaceuticals to our first in Human podcast. Welcome Simon.
Simon Allen: Yeah. Thanks very much, Rich.
Rich McCormick: Why don’t we start with a little bit about your background and what led you to becoming the CEO of Anebulo.
Simon Allen: Well, I’m Australian. I started my career back at Sydney University undergrad in genetics and biochemistry. My first job was to DNA fingerprint yeast before moving to California and chasing biotech, which I’ve done since the early nineties. I joined Gilead Sciences. Worked in the lab on their antiviral programs before doing an MBA and working in the capital markets, both on the banking side and analyst side. What I’ve enjoyed over the last couple of decades, is what I call cell side biotech business development, which basically leads me now to leadership and others to Anebulo.
Rich McCormick: Anebulo is focused on developing disruptive treatments for substance abuse disorders. What inspired you to pursue this area of research?
Simon Allen: This is a very focused area of research. In fact, it’s more clinical, as I’ll get into. We’re a phase two. We don’t do any primary research at Anebulo. It’s a single product to treat acute cannabinoid intoxication, or too much cannabis. We’ll get into that in a little bit. The focus is very narrow and that was my intrigue. I’ve worked at quite a few biotechs and they all have different opportunities. This one, to me, is extremely exciting and focused.
Rich McCormick: Your small molecule compound, ANEB-001, is used to treat, as you mentioned, cannabinoid intoxication. Can you explain a little bit of the science behind that?
Simon Allen: So, acute cannabinoid intoxication, which is a condition under the DSM five the psychiatric bible, if you will, is nothing more, in my opinion, as having too much cannabis or THC cannabinoids on board, which can be inadvertent or advertent. It happens a number of different ways, and we have a small molecule, ANEB- 001, and it does one thing and one thing only, and that is it blocks the CB1 receptor. The CB1 receptor is essentially the way that cannabinoids apply their psychotropic effects. Unfortunately, if there’s too many cannabinoids, the CB1 receptor, if it’s overloaded, shall we say, can put you into acute cannabinoid intoxication. And so our drug, 001, is designed to reverse very rapidly the key symptoms of aci.
Rich McCormick: Interesting. So is there a specific time window where your treatment has to be aligned with a patient in need?
Simon Allen: A lot of people think of Narcan, which I think is an appropriate setting. There Are some differences. Most people may not be aware, but Narcan is now destined to go, over the counter, you can pick it up at your Walgreens and CVS. In fact, some countries have made it available in their bars and other areas where opioid overdoses might occur.
I digress. That’s a rapid, nasal formulation. Right now, we are developing an oral formulation. But we also have what’s called a parenteral program, a fancy word for an injectable, which would give doctors in the emergency department setting not only the oral route of administration, which is our current path, but also what we consider to be a very rapid parenteral.
And even in the future, potentially nasal. We’re not as developed as Narcan. Narcan’s been around to treat opioid overdoses, for some time. So we are definitely behind that curve, but we have all of those routes of administration available to us.
Rich McCormick: How does your Anebulo team approach the hot topics of patient advocacy? Community outreach? Do you feel that it’s more critical with addiction treatment, than other diseases or disorders in terms of patient advocacy?
Simon Allen: We do monitor the advocacy and community as best we can. We’re a relatively small company. The good news here is that we can focus it exactly on what we need [00:05:00] to do, which is the key opinion leaders and those people dealing with it at the emergency department setting, the hospital administrators, the emergency doctor departments and the healthcare system overall.
We’ve gone rather deep in our market research. Some of that’s available. In fact, all of the pertinent stuff really is available in our non-confidential deck available on our website. There’s just a lot of other data and information, which we keep proprietary just because we’d like to think we’re the first ones doing this.
It’s quite encouraging, I would say. In that this is a growing social issue. These edible gummies now are coming out extremely high potency. Treating these at the emergency department setting we think is a key unmet medical need.
Rich McCormick: Do you see increased cases in states where there is legalized marijuana?
Simon Allen: There’s a lot of different things you can find on the internet and a lot of different studies that you can point to. One of the common circumstances within the industry is that as you make these products more potent, cheaper and the prices of these have come down substantially, even with the tax burden. They become more accessible and even more disguisable in the sense that what we had ten or fifteen years ago, certainly when I was growing up at university, these products were maybe fifteen to twenty percent .
They’re all ninety plus now. I shouldn’t say all of them. The ones that cause problems in the emergency department are typically, or can be these high potency edibles. So, the game has changed, and Yes, to answer your question, maybe that’s a long-winded way of saying there’s not much argument that as you deregulate, decriminalize, legalize and put dispensaries around every corner, we would even submit that some packages of edibles get lost and might get ingested by canines that have an order of magnitude greater CB1 receptors in their brains than we do and are quite susceptible to ACI. I’m not saying that’s a big opportunity, but it’s a canary in the coal mine, if you will, as to what this really could do society-wise for us.
But, we’re just focused right now on the emergency department. Now, don’t get me wrong, we don’t think we can do everything to everything with regards to the cannabis industry. No. All we do is treat what we believe is a serious condition. As people present with too many cannabinoids in the emergency department setting,
Rich McCormick: Is your team looking into any other uses for substance abuse, other than what you’re currently exploring with ANEB-001.
Simon Allen: We’ve always got that on the radar. There are other opportunities. People even talk about using cannabinoids, even regular Delta-9 THC as a therapy for pain management or appetite, whatever. I applaud them and I say, “Have at it.” That’s not what we focus on. We’re removed from that. As I just mentioned, all we really do is focus on the emergency department setting, acute cannabinoid intoxication. We do have our eyes very much set on what a CB1 antagonist does, which is. Our molecule, 001 is a very strong CB1 antagonist. That can have other applications, I should mention.
And yes, we do have our radar focused on that, but for now, there’s no reason. In biotech, you talk about risk. Risk is sometimes defined as taking on too much than you can handle. We think we can handle this and, just do quite nicely with the team that we have in place.
Rich McCormick: What do you foresee as the future of cannabinoid based therapies?
Simon Allen: It’s been going on for decades, the cannabinoid system, CB1, CB2, and other receptors associated with that system have been relatively well studied for things other than ACI, clearly. There’re therapies to be found. As to our expertise or particular understanding of that. Well, it’s deep, but as I said, we remain focused on ACI and if there are other opportunities, I’m sure we’ll be the first ones to maybe figure that one out.
Rich McCormick: What advice do you have for industry leaders in the biotech space that are working to develop new treatments for challenging diseases and conditions?
Simon Allen: That’s a very broad question. Hopefully most people would agree that “team” is everything. The underlying asset is important. The market opportunity, intellectual property, I would always go to that. CMC manufacturing. There are a number of areas, but that’s almost like saying to an architect, “What keeps a building sturdy?”
There’re multiple things that you could talk about. For me, I would say the mechanism of action for ANEB-001 is one of the cleanest and strongest I’ve ever had the fortune of representing. How can we apply it for the treatment of ACI? That’s the fundamental question. We hope to answer that in our phase two, which we recently completed Parts A and B. ANEB-001 has one of the cleanest MOAs. I’ve discussed that before. Our next important step is to meet with the FDA, which we’ve given guidance to mid-year, this year.
We’ll be able to discuss [00:10:00] the data of our phase two, as well as, what we call an observational trial, which is fascinating. This is where we go to emergency departments, not talking about 001 or any potential therapy. Just looking for individuals that present with ACI. You can’t get somebody to consent that’s intoxicated. That’s not legal or ethical, certainly in the United States, I would hope. After the fact, as you probably know, hospitals take a blood draw almost routinely for these circumstances.
We can go back and when they’re not intoxicated, say, “We’re doing an antidote here, a potential therapy. Do you mind anonymously? We don’t need your name. Could we take a look at your blood? And see how much THC you had.” Look at the biomarkers, if you will, of ACI in actual patients.
That can be used effectively in a modeling circumstance, which we work with the FDA to look at healthy normals. That’s how we test our drug, which I think is a fascinating area to look into. How do you test for something that’s lethal? THC is not lethal. Don’t get me wrong. But to ethically push somebody to an intoxicated state is not where doctors are typically comfortable, nor should they.
And the IRBs of clinical trials are very sensitive to this as they should be. So, we’ve had to start with fairly low doses of THC in healthy normals to essentially get them high to the point where intoxication may or may not occur. And to me, this is uncharted territory, but when I hear from the clinical trial site that an individual was unable to get off the sofa to complete one of the tests that we do every hour for eight hours, I’m thinking that person may or may not be intoxicated.
Yes. I think that person may be. And so, we pushed it to areas now where clinically it’s relevant from a modeling perspective, and we hope to align that with our observational study. And have a discussion with the FDA, which we’ll await to have, mid-year, this year.
Rich McCormick: That’s great, Simon. Thank you so much for your time today. It was really interesting to hear about what your company is doing. We wish you nothing but the best of luck. We’ll be watching and rooting for you.
Simon Allen: Fantastic, rich. I look forward to it.
