Chad Harman, CEO of the company Psychaceutical on Neurodirect and Ketamine

Dr. Mark Leeds [00:00] Chad Harman, welcome to the podcast.

Chad Harman [00:01] Thanks, Dr. Leeds. I appreciate you having me. It’s an honor and pleasure to be here.

Dr. Mark Leeds [00:06] Thank you. So you’re the CEO of the company Psycheceutical? So, yeah, tell us a little bit about what you do there.

Chad Harman [00:17] Sure. We’re a bioscience company really focused on mental health treatments, utilizing psychedelic medicines as our lead compounds. And with the revolution that’s happening with psychedelics, what we found is the primary issues that we’re seeing, Dr. Leeds, is really centered around dosage control for psychedelics. Obviously, they’re very profound. A lot of great clinical results have shown the past several decades, but more precision targeted dosing control is what’s needed for the industry. As you know, there’s a lot of profound effects from psychedelics. Psychogenic effects, hallucinations, nausea, vomiting. So there’s many profound effects in terms of its therapeutic use. But, you know, in terms of the side effects, they can be, you know, not well tolerated for patients. So we’ve, we have, specific technologies that address those, those very issues. And so we look forward to bringing those, through the FDA clinical trial pathway.

Dr. Mark Leeds [01:23] Oh, wow. Wow. And when you say psychedelics, is that, you know, I mean, they’re all a little bit different, you know, everything from LSD to psilocybin, MDMA. What are the other ones? Ayahuasca, ibogaine, ketamine, like each one has like its own unique properties and maybe like different ones are useful for different conditions or better for one condition than another. Which ones are you primarily working with?

Chad Harman [01:51] Yeah, I mean, we’re really focused on ketamine as our first drug taking it through the clinical trial pathway. We chose ketamine because it is very profound in terms of its utility and use when it comes to PTSD, depression, anxiety. And it’s a Schedule 3 drug. So we know it’s well tolerated. And a cool fact is, you know, one of our technologies, Janus Particle, it’s licensed from the University of Michigan, and that’s where they first synthesized ketamine. So it’s kind of a full circle there. And so what we found, Dr. Leeds, is one of our other technologies, NeuroDirect, it has very profound effects to alleviate a lot of the side effects that we just discussed. And so because Schedule 3 drug can be used in the clinical setting, it’s a faster path through the clinical trial pathway versus going to MDMA, psilocybin, LSD, all the other psychedelic compounds. So, you know, for us and our investors, it was a huge target going after PTSD using NeuroDirect for ketamine. But it also represented, you know, again, a means to move forward in a very expedient format using ketamine. But we certainly look forward to looking at the other molecules, specifically MDMA is another compound we’re interested in, psilocybin, and then some others to treat addiction disorders.

Dr. Mark Leeds [03:31] Okay. And so ketamine, it doesn’t work. And like, I don’t think you can take a ketamine pill that, you know, I don’t think it can be absorbed significantly through the gastrointestinal tract. So, you know, you have like these ketamine clinics doing intramuscular and IV ketamine treatments. What are you guys using to get ketamine into the system in an accurate way?

Chad Harman [03:57] Sure. That’s a great point. And let’s do a little contrast. So existing treatment, as you mentioned, is IVIM. There is Spravato, right? Janssen Pharmaceuticals has an intranasal drug that they’ve developed, right? All those are administered in a clinical setting, and it’s very expensive, right? You’ve got the, you know, not only the doctor costs there, the drug itself, and then you also have all the monitoring as you go through the experience, right? And patients in the traditional oral or systemic administration of those compounds you just mentioned, you know, comes with, you know, psychogenic effects, oftentimes GI irritability. So, you know, oftentimes you have to deliver like Zofran, for instance, to an anti-nausea medication. And then you’re going to have to monitor the vital signs, blood pressure. And again, on the back end, there is some severe lethargy. And then, you know, patients have to be oftentimes driven to and from those appointments. So it’s a very cumbersome way of administering ketamine. Obviously, very, very profound effects from that. But it’s a very expensive cost of care model. And so what we’re going to be doing is we have a topical administration of ketamine, which it’s new. And so what we’re doing is a completely instead of using a systemic format of delivery, we’re using what’s considered a non-systemic, meaning it’s not going into the bloodstream. We’re not going through the circulatory system and having issues with GI system or profound psychogenic effects. And so with the neurodirect technology, it was invented and created by Dr. Ronald Aung-Din. And he is a neuropsychiatrist and neurologist at Sarasota, Florida. And he’s been a part of better part of 50, 50 clinical trials. Well, over 30 of them have gone on to FDA approval. And so in his practice, what he was looking for, Dr. Leeds, is the ability to bypass a lot of the systemic side effects of traditional neurological medications. And so what he found was that if he placed a neuroaffective compound in a topical cream format at the back of the neck at the hairline, and only that spot on the body, he found profound effects. And so meaning that if he and his first drug that he brought to market or brought to market, but he patented was for sumatriptan for severe migraines. And what he found is in the oral setting, they would dose in an oral administration. And if they didn’t catch it immediately, there was a lot of symptomology remaining. So it often took 35 to 45 minutes, and those patients often just didn’t see the relief that they were looking for. So with the neurodirect delivery platform, they’re able to dose immediately, get effects, and almost complete remission of symptomology within several minutes. So now take that same administration, you take it into the IV or you take it into ketamine and with a topical administration within several minutes. And he’s been he’s been dosing patients with the neurodirect ketamine in off-label format for the better part of a year and a half. And it was actually just quoted this month in Drug Delivery magazine. It was a peer-reviewed approved article that showed him taking 100 patients and he did an observational study and there was quantitative measurable results that showed that 80% of the patients with severe PTSD, treatment-resistant depression, patients that really didn’t have any treatment model whatsoever, any relief, and 80% of those patients responded favorably. And so for us, that’s a huge, huge benefit. And to patients, it’s a new way of delivering neuro-effective compounds safely and effectively and getting them the relief without all the other side effects. Matter of fact, what we’ve heard from many doctors around the country, clinicians, our medical advisory board member, Dr. Julian Bales, who runs 10 hospital and clinics there in Chicago, said during the pandemic that more and more that we’ve got physician and nurse burnout. Out. We have patients coming in that are seen, you know, weeks, if not months before they can see a therapist. And so we’ve got this rise of epidemic proportions of patients that need relief from these severe anxiety, panic disorders, and this disruption. And he and many others say, hey, if we can go in and deliver this topical administration ketamine, start to have a dramatic reduction in overall symptomology, and then start to triage and treat these patients in a remarkable manner, this is going to be very profound for the entire industry. So again, we’re not going in systemically. There’s no patch. We’re not going to the bloodstream. So this is a completely new route of administration that we look to have as a breakthrough delivery technology.

Dr. Mark Leeds [09:36] Okay I was thinking with topical creams you know like when I saw ketamine cream there was a years ago there was a company that I and I think it was like a local compound pharmacy but they created a product and the interesting thing was that their marketing was like you know to make them kind of look like a pharmaceutical company and you know they had a guy that came in that he was like a drug rep and he brought samples of it in and I think going back a little further maybe 15 years ago plus or minus a little I remember compound pharmacists getting really excited telling me you know we have this new delivery system that gets medications across the skin and it was liposomal something or other whatever this stuff is and suddenly there’s this explosion of pain creams you know we were getting like these flyers like all the time non-stop from pharmacies saying here’s a pain cream with this stuff and this stuff and almost anything you think of that might help with pain there was like an anesthetic and anti-inflammatory, a muscle relaxer, just a blend of stuff. And this one, the one ketamine one I was talking about, they had a list of stuff also, but they were putting like 25% ketamine, which was like a lot for those kinds of creams. And yeah, then later I found out like the proper dosing probably should be starting at five, you know, maybe two to 5%, then maybe 10% at the upper limit, 15%. But yeah, so, but these creams, they were intended to go like wherever you have pain, You know, like if you have pain in your leg, you put it on your leg. If you have pain in your lower back, you rub it in your lower back. And, you know, there’s some doctors that were really excited about that. So is this not the same thing as those kind of muscle pain creams, you know, and those kind of things? Is this a different kind of a delivery system?

Chad Harman [11:19] Sure. Yeah. I mean, it certainly can handle, you know, pain. But what and I think what we have is specific to the location and where it’s administered so we have a method of use patent that precludes or prevents individuals from applying any any compound at the back of the neck of their hairline basically that c3 c4 area so that if anybody markets or sells that specific area on a drug label or tells an individual to apply it there at that region, then that infringes on our patent. So from the standpoint of looking at pain, we certainly see a lot of symptomology that we’re able to handle as part of our technology. But again, what we’re going after is PTSD, which, you know, you know, some of the comorbidities are often pain, sleeplessness. I mean, you know, there’s a whole host of other indications that go along with PTSD. So for us, what we know and what we’ve documented is that when they place at the back of the neck of their hairline, those that have, you know, severe anxiety, panic disorder, you know, they’re getting immediate results within minutes. So, you know, more of the mental health disorders. We are looking at CRPS as another indication to go after. And we’ve seen 25 patients have immediate response to the administration.

Dr. Mark Leeds [13:06] Yeah. And I should point out, you know, I mean, just, you know, there’s compound pharmacies that do all kinds of crazy things, you know, with what they have. And that doesn’t necessarily make it a good idea. You know, like you had mentioned Spravato, the nasal spray that has the S-ketamine isomer in it. And it’s very strict. I looked it up to see, like, could I administer this at my office? And I mean, you know, you have to like register the pharmacy, the doctor, the patient, you know, it’s a very thorough system to make sure that everybody is safe. And then there’s a compound pharmacy like, oh, yeah, we’ll make a nasal spray. Like, oh, OK, well, hopefully everything goes OK with that, because, you know, FDA approval does mean something. And the other thing is insurance. You know, insurance typically doesn’t want to pay for off-label things. So that’s that’s another benefit but yeah I mean I think you know when it comes to safety you know there are people that do definitely want to stay on the path of like I’m only going to do what’s been approved by the government for this particular use you know like it’s a scary thing when you find out these doctors doing epidural injections that none of that is I don’t think any of those are FDA approved you know it’s like what are you even shooting into me where’d you get it from to come from a compound pharmacy a real pharmaceutical company so there’s something to be said about you know, things being done through the appropriate pathway. So,

Chad Harman [14:26] Yeah. Yeah. And what I would say to that as well is, you know, more than now than ever, especially when we consider the mental health space and the epidemic proportions that we’re at today, you know, more, more so than ever. And the statistics are out there that show, you know, more than, you know, 60, I think 60% is where we’re at based on some studies that our frontline doctors like our general physicians, nurse practitioners, physician assistants are prescribing these frontline medications, SSRIs. And again, we know that stats tell us that 30% of the respondents actually have some type of relief from these. And again, it takes six weeks. So what we wanted to create, Dr. Leeds, is something that handles a big issue and need and challenge, not only for patients, but also for our frontline doctors and therapists to give these patients immediate relief. I mean, suicidal ideation is on the rise as well. And so we’re seeing these people suffering left and right, and we need to provide those tools for our frontline doctors. And this is something that, again, you’re not having to register in a clinical setting or pharmacy. This is something that these frontline doctors can can write the script and these patients can get immediate relief. So that’s what we’re very, very excited about and differentiated from everybody else in the industry. Right.

Dr. Mark Leeds [15:56] Yeah. So that’s that’s that’s a huge thing. I mean, because, you know, like I said, when I looked up how can I give a patient Spravato that it was just there’s no way I’m going to go through all that. And so then the next step is like, do I want to send the patient to a ketamine clinic? I mean, I don’t know. I don’t really know the clinics around here that, you know, they’re popping up everywhere. And, you know, and it’s a little bit scary saying, OK, go get an IV at this clinic. So you’re saying that this is something that would a doctor order it or would they would write a prescription and they go to a pharmacy and pick it up? And do they bring it back to the doctor to get it administered? Do they do it at home? I mean, how does it work like like if a primary care doctor wants to get involved with this?

Chad Harman [16:37] It’s a great question. So the yes, they would write a script. The patient would pick it up. And this is the great news. Again, it doesn’t have to be administered in a clinical setting. You don’t have to have a therapist present for any of that. So, you know, patients would be able to dose, you know, on the job, at home. And we’ve, Dr. Aung-Din has even had patients, you know, they have severe anxiety or panic attacks when they get into, you know, crowded spaces or they’re on the freeway and there’s a ton of traffic and they’re stopped. Patients being able to apply that cream, you know, within minutes, several minutes, and they’re getting relief. They’re really able to calm the nervous system. And for many of these patients are saying I’m able to actually gather and collect my thoughts and have this moment of clarity that I have not had in years or even sometimes decades that relief it was just been so profound it’s been a very emotional it’s been very emotional for Dr. Aung-Din to see that with his patients have that relief within minutes of administering so you know again this is something that will change you know how we can administer that and Again, we’re not waiting six weeks with traditional SSRIs to take hold to see if it’s going to work or not. And as you know, Dr. Leeds, many of these SSRIs are administered, and then oftentimes they’ll start to lose their effectiveness over time. And then you’ve got to switch them to something completely different here. So what we hope and anticipate through the clinical trials is these patients are getting relief, and then they can taper off. And it’s really as an as needed basis that they’d be able to use this medication.

Dr. Mark Leeds [18:18] Yeah, I think that’s something that people are becoming very much aware of that, you know, based on new reports and studies and discussion of it, that the SSRIs are not, and a lot of the antidepressants, a lot of these things are not what we thought they were. They’re minimally effective. They have a lot of side effects. They’re probably not safe for long-term use. They need to be tapered off very carefully. And the companies that make them didn’t really give anybody any instructions on how to do that. So there’s just a lot of negatives. And ketamine has, you know, when you look at the package insert, you know, the product information from the FDA of all the things to look out for, it’s a very short document. You know, when you look at it, you know, I forgot what the brand is. It’s like a brand of ketamine. I think Kevlar. You know, you look at that product information, you’re like, well, where’s the rest of it? It’s very short. There’s not a lot there. And you look at any SSRI, and it’s page after page of adverse effects and side effects and black box warnings. I think Spravato may have some black box warnings, but that’s a different kind of ketamine. That’s S-ketamine. But yeah, the old traditional ketamine, there’s just very little there to worry about relatively.

Chad Harman [19:32] Yeah. And one other thing I do want to comment on, too, just when we look at ketamine, we look at just psychedelics in general, you know, we’re going to carve out a substantial patient population as well. Right. We’ve got adolescents now more than ever I mean case in point right recent news is the Nashville shooting right we had a teenager a 28 year old go in and start shooting up we’ve seen teenagers with the Uvalde situation last year with the shootings we’ve seen more and more suicide suicides happen more in adolescence more more so than ever coming out of you know post post pandemic and then we’ve got, you know, as we think about the patient population for psychedelics, we’ve got the senior population, and then we have those that are opposed to having a psychogenic effect. And then we have those individuals that just would not qualify due to, you know, medical conditions. So with our mode and our delivery, you know, we open it up to all those various populations, right? There’s no psychogenic effects. So adolescents are going to be able to, potentially get the relief they need with our solution senior. And again, we’re going through phase one and phase two trials here shortly in Australia. And so what we hope to see and what Dr. Aung-Din has seen is that there’s no, you know, no, what we’ve, what he has seen in the office is an actual reversal with ketamine. There’s a spike in blood pressure that occurs. So is one of the side effects. Well, what he has seen is actually, because it’s so anti-anxiety, ketamine, we’ve seen a reversal in the topical administration to see that it starts to normalize blood pressure levels. So, you know, now we’re starting to really encompass, you know, everybody in that patient population. So, we’re not, you know, hopefully going to have the ability to be able to dose anybody and everybody, right?

Dr. Mark Leeds [21:39] Okay, and I want to go back to something you mentioned. If someone is having a lot of anxiety because they’re stuck in a traffic jam, if you go to a ketamine clinic, they tell you can’t drive. You need someone to pick you up at the clinic and drive you home in 24 hours, no driving. So there’s no restriction with this.

Chad Harman [21:57] No, no, not with what Dr. Aung-Din has seen. And, well, again, we have not seen any systemic absorption. So by what we’ve gathered or what he has gathered and collected, it can be taken anytime, anywhere without any side effects. Again, here’s the good news is, you know, many of these patients are on, you know, multitude of drugs, whether it be SSRIs or benzos. And so there seems to be no drug interactions whatsoever. So, you know, patients can start to really wean off those other drugs, as you know. You know it can be very detrimental you know weaning off some of these ssri ssris and can create a lot of issues and so what Dr. Aung-Din has seen is some you know many of his worst case patients they’re on several drugs they’re able to wean off a majority if not all of them and just remain on the NeuroDirect ketamine

Dr. Mark Leeds [22:58] Okay is this something that we’ll be able to get like in like for example at walgreens

Chad Harman [23:05] Yes that’s that’s what we’re that’s what we’re going through that process with the fda yes

Dr. Mark Leeds [23:10] Okay so it’s not like a specialty pharmacy it’s like pretty much your your neighborhood corner pharmacy whether it’s one of the big chains or independent like it’s okay and what is the manufacturing like with this I mean I don’t I don’t know how that works but I you know I know like you know people you know like like when you go into like I said one of these compound pharmacies you know at the best you know they may have like a little lab behind a glass window and you know there’s a guy mixing stuff up and you hope he’s having a good day and whatever but that’s you guys are like like kind of probably equivalent to like a you know a real pharmaceutical company you know like we have like these companies and I know there’s one in florida like ivax or something in miami that they make like a whole bunch of generic drugs and whatever but that’s a whole different thing compared to like a little pharmacy making stuff?

Chad Harman [24:00] Yeah, I mean, it’ll really go to a CDMO. I mean, it’ll go to, you know, much similar to, you know, a large pharma company like, you know, Lily Johnson & Johnson. So it’ll go to, you know, an FDA CDMO where they will make sure that it’s following strict guidelines in terms of, you know, making sure the product is safe, shelf stability, that it is consistent in terms of oral quality. It is going to be in a FDA approved meter dose bottle. So every pump will have the same milligram dosage for each pump. So all of that will, you know, meet FDA standards. And to your point, it’s not going to go to a specialty pharmacist, you know, going into their little lab and, oh, well, you know, I’ve got a tolerance of 15%. So if I’m off a little bit, we’re okay. No, this is going to be, you know, to, you know, strict pharma guidelines, from a manufacturing standpoint? Great, great question.

Dr. Mark Leeds [24:58] Yeah, when you mentioned the pump, that’s a really popular way to get testosterone. I have some patients that use those testosterone cream pumps and they have the little packet ones that are hard to deal with and then they have the injectable that nobody wants to do. But I have several patients that just love the pump. It gives you that exact meter dose and they put it on whatever area they’re supposed to put it on. And so, yeah, it’s really it’s really a great way to administer a topical medication.

Chad Harman [25:27] Yeah, absolutely. Absolutely. And I think, you know, for us, too, and for your audience as well is, you know, kind of going beyond even, you know, just the general, you know, doctor situation. I think I touched on it a little bit, but, you know, where I think we’re going to be very remarkable in terms of its uses moving forward, too, is again going into emergency rooms or urgent cares. We even envision some of our first responders, right? So more of our EMS, our firefighters and our police force, being able to provide this as a potential tool while individuals would be in a hysterical mode and trying to triage patients in that manner is very, very difficult, as you know. So we envision this, you know, even going beyond just a normal, you know, doctor setting to now encompass, you know, more of frontline. All right, we’ve got a patient in a hysterical mode. Let’s calm the autonomic nervous system down. Let’s be able to triage this patient. So I think that’s going to be certainly something very, very different again than anything else that we have treating, you know, severe panic attack, anxiety disorders, you know, that fight or flight mode.

Dr. Mark Leeds [26:49] Yeah, that’s really great because there’s not a lot of good stuff out there. Like we talked about the SSRIs and now we know as of just a few years ago, you know, the benzodiazepines are toxic. You know, they’re definitely not for anything more than just very short term use. And when you give someone with anxiety benzodiazepine, like Xanax, Klonopin, Ativan, they get used to it really quickly. They’re like, wow, this is great. Keep giving me more. And then they get stuck on it and they get really bad toxic brain effects. It’s hard to get off of. So we would rather not start people on them in the first place. But there’s not a lot of good alternatives. There’s antihistamines and, you know, there’s a couple of things that just don’t work very well or they’re also not very safe. But it sounds incredible. You’ve taken something that we already know is safe and effective and proven for decades and put it into a packaging and a way of administering it. I mean, another thing that comes to mind is, you know, a lot of people talk about microdosing with the psychedelics, although none of them are really, really legal. But I hear people talking about microdosing with psilocybin, taking below the amount that would have any kind of noticeable effect, but they still feel like there’s some benefit from it. And, you know, then you hear about Hollywood people and, you know, celebrities take microdosing LSD and taking something far below what they would get a psychedelic effect from. So it seems like you’re actually bringing some of those benefits to the market. Like, you know, you may be the first one out there. You know, there’s companies talking about, like, someday when psilocybin is legal, you know, we’ll have a thing for it. But you’re already on the path. Like, how soon can we expect to see this?

Chad Harman [28:29] Yeah, so we’re going through phase one and phase two trials in Australia, as mentioned earlier. So that phase one is commencing May 1st. And then in Q3, early Q4, we’re starting phase two. And so what we expect is that’ll take about a year. And then in parallel, we’ll be working on our phase three. So 2025 timeframe. So it depends on obviously the results of phase two, where we land there. But given the remarkable results and 80%, which is far above what we would consider acceptable by the FDA standards, we feel like this would be, you know, certainly we can fast track with the FDA because of reducing or alleviating all the side effects and showing, you know, increased safety profile. So what our FDA regulatory consultants have said, hey, we can apply for that fast track. And so sometime in 2026, 2027, again, these are all estimates and based off of some of the experts that we have in our corner. So, again, we’re going to put as much pressure as we can. We know that the patient population needs us. Our frontline doctors need it more so than ever. So we feel like we have something that’s very valuable. And again, the VA, one of our patent holders is a former Navy SEAL. He is very tied in with the VA. We’ve got a lot of political ties at Congress and with our four-star generals. And so we’re going to put as much political pressure as we can because of the safety profile that we’re bringing to the table, because there’s a lot of anecdotal evidence to support it. And certainly once we have the phase two, so we’re going to press on every single lever we can to get this in consumers’ hands as fast as we can.

Dr. Mark Leeds [30:36] That’s great. Yeah, I’m sure people who are going to be listening to this podcast are probably going to think, I wish this was already out there. I wish my doctor could write the prescription. And we’ll be looking online at your website for the little discount card, you know, like the trial, one that we can start out with and everything. But yeah, it’s exciting to see like a real product coming to market, you know, that’s filling this void. You know, there’s really nothing like it out there. So, okay, Chad Harman, thank you for joining me. And we’re really excited about hearing what happens next with Psycheceutical. And oh, sorry, what’s the name of the product? Is there a name for it yet?

Chad Harman [31:16] Yeah, it’ll be NeuroDirect Ketamine is what we’re calling it now. Obviously, once we get to phase three, we’ll call it something different, right? A more pharma type name. So I’ll let the marketing experts figure that out.

Dr. Mark Leeds [31:31] Okay great great okay thank you thank you again for joining me

Chad Harman [31:34] Yeah it’s an honor and pleasure and I appreciate you