Talking Biotech with Dr. Kevin Folta

Mental illnesses such as anxiety and depression are being diagnosed with increasing frequency. At the same time, treatment is frequently dependent on legacy drugs that oftentimes to do not work well, have drug interactions, or can lead to addiction or dependence. New therapies are also available, yet they they are systemic and can also have drug interactions and unfavorable side effects. New therapies are needed, especially those with more direct delivery to the relevant regions of the brain. Shawn Singh, CEO of VistaGen, describes their new drug candidates that target depression and anxiety. The novel compounds are delivered as nasal sprays, providing direct interaction with neurological pathways in the olfactory bulb that connect directly to the regions of the brain that affect mood and anxiety. These candidate therapeutics are less likely to drive side effects due to the low levels delivered and their direct interaction with the brain.
 
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What is Talking Biotech with Dr. Kevin Folta?

Talking Biotech is a weekly podcast that uncovers the stories, ideas and research of people at the frontier of biology and engineering.

Each episode explores how science and technology will transform agriculture, protect the environment, and feed 10 billion people by 2050.

Interviews are led by Dr. Kevin Folta, a professor of molecular biology and genomics.

Talking Biotech Podcast #386
Treating Mental Illness through Nasal Drug Delivery
Shawn Singh, VistaGen - Guest
Dr. Kevin Folta - Host

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Kevin Folta: [00:00:00] Hi everybody and welcome to this week's Talking Biotech podcast by Colabra. Now usually I do a little bit of an introduction and introduce some bit of the information before the guest comes on, but I think we'll let him do most of the talking today. We know that mental illness is a problem and that anxiety and depression and other mental illnesses are becoming increasingly prevalent, and there's reasons.

But one of the underlying factors is that treatment has been reliant on old drugs and sometimes new ones that can have harsh symptoms. We've all seen the TV commercial with the laundry list of things you have to look out for when you're on some kind of new pharmaceutical. Today we'll talk to Sean Singh from VistaGen.

We'll talk about the new types of therapeutics and the novel way in which they're administered. So welcome to the podcast.

Shawn Singh: Kevin, thanks a lot. I appreciate the opportunity to speak with you and your audience today. Great to be here.

Kevin Folta: Yeah. Well, [00:01:00] thank you for being here because mental health is becoming apparently an increasing issue.

We see more and more of it in the spotlight. It seems like that the incidence is increasing, but is that because of increased surveillance and maybe more acceptance or sensitivity? Or is modern life really causing more anxiety and.

Shawn Singh: I think it's, it's a both, there's no question we're seeing alarming increase.

In the prevalence of a whole range of mental health disorders, but there's also extremely higher awareness and and all kinds of analytics and metrics associated with, with gathering data. But, you know, look, the, there's no doubt that the Covid 19 pandemic, isolation, minimal social interaction, you know, people losing lives, devastating effects on people's mental health.

I, I often say the pandemic didn't create our mental health crisis, but it definitely [00:02:00] magnified it. And on the positive side, if there is a silver lining from the pandemic, it's that it, as you said, it has shined a spotlight on mental health and in some ways it's had a positive impact on opening dialogues in schools and workplaces and homes.

It's sort of okay to not be okay because of all the obvious stressors. They're associated with the pandemic and. We've done a lot, a pretty good job in the last few years, destigmatizing mental illness and allowing that awareness to translate into into help and intervention, but still have a long way to go to destigmatize mental illness and make it akin to dealing with the physical illness, right?

That impairs your ability to perform and be who you want to be, but no doubt. Also, your last point about modern life, I mean, Just take a look at social media alone that has had effects on mental health that were [00:03:00] never conceived decades ago. And we've seen some recent data from CDC in particular about teens in crisis.

So it's, it's scary. At the same time, there's, there is hope on the horizon based on the national embrace of the problem. And typically as a country, when we see something that we need to fix, we do a lot of things to try to fix it. So I think the trend is going the right direction. In terms of trying to correct it, but unfortunately the number of cases is still on the rise.

Kevin Folta: And when you say on the rise, how prevalent are mental health issues and what disorders are we seeing the most?

Shawn Singh: Well, our focus at Vistage is primarily on anxiety and depression disorders. And one of the things I noted recently when the president did his State of the Union, was in his, his textual preparation for that.

He said 40% of American adults report symptoms of anxiety and depression and that the percent of children in adolescents with anxiety and [00:04:00] depression that's risen nearly 30%. So, , it's it's troubling and there's no question that we're seeing large increases in anxiety disorders such as social anxiety disorder depression disorders across the board, especially major depressive disorder.

So these are definitely things to take to pay attention to. There's about 24 million people in the US that suffer from social anxiety disorder. There's about 20 million adults that. Having at least one major depressive episode within the prior year. So 44, 40 5% of high school students say they've experienced persistent feelings of sadness or hopelessness during the pandemic That, you know, it's it's definitely time for a call to arms across the whole entire ecosystem.

Not just the pharmaceutical community, but every aspect of that ecosystem to to be galvanized into. Try to address these and change the trajectory of of mental health. [00:05:00]

Kevin Folta: And I guess being a devil's advocate, I might say, well, okay, these are somebody's personal issues, issues to tackle with the family. How is it my problem?

And so what are the social and economic ramifications in the broader sense of untreated mental health disorders?

Shawn Singh: I think there are many beyond holding people back from reaching their full potential. I mean, the economic ramifications are huge. There's absenteeism, there's presenteeism where people are at work, but they're not able to perform as well as they should.

Those are major challenges and people with mental health issues are far less likely to, to get married, to have strong social networks of support. So these are, these are significant unmet mental health needs and. When you don't receive the right care at the right time, it's gonna spill over into all facets of society, around us, and especially the research around teens and certainly also [00:06:00] adults with mental illness and substance abuse disorders.

They have a lot of trouble engaging with other people at school and the workplace. And overall, the relationships are less healthy, so that spills over into all avenues of.

Kevin Folta: and usually when we're talking about mental health, we think about different types of therapy that are, are non-pharmaceutical, but when medications are prescribed, how are those working in the broader context and how effective are they?

Shawn Singh: Yeah, it's a mixed bag. You know, they're the one thing we always know and. There's no one size fits all solution for people with mental health disorders. Many of them are just very individualized. And people with these various disorders say anxiety, depression. , you have different stops in your journey, different types of journeys.

As a patient, what might be impacting you in adolescence as in an activating trauma is, is possibly gonna impact you [00:07:00] differently when you're in your twenties or your thirties or even later in life. So, meeting people where they are in their journey with appropriate talk therapy, which really always has to compli.

Any medication based therapy it's a critical component and especially peer-to-peer talk therapy, which is what I think is tremendously effective, is if there is someone with a mental health disorder is speaking to someone they can relate to, they can trust someone who looks like them, is like them, has been through their journey.

It's just far more effective than the disconnect it sometimes happens. Between a therapist say, and, and someone who's talking to that therapist, if they're completely different in the communities that they come from if their orientation is completely different, they're, the benefit of that talk therapy is different, but, I think it's access to that therapy is also important, right?

The type of ability to access medication, [00:08:00] to access talk therapy those are essential components, but unfortunately we know a lot about the current meds. They've been around for decades, and these are for anxiety and depression disorders and the profiles. are very well established and many of them don't fit the type of experiences that people actually have to deal with.

And there's long onset of action. There's a lot of rinse and repeat, meaning try one thing. It doesn't work after 6, 7, 8 weeks. Then you per depression, for example. You go off that wash out, try something else. So there's a lot of that. And finally, you know, people do land on things that help. There are side effects, there are safety concerns with existing medications, so we really need fundamentally different types of medications for that part of the equation than what we've had and that are available now with current treatment.

So there's just a lack of broad efficacy [00:09:00] and, and there's side effects that are troubling and cause people often to abandon that effort. , it doesn't get rid of the underlying problem, obviously. It sometimes makes it worse. So,

Kevin Folta: and you mentioned Covid-19 and how is this really amplified the, I, I guess the occurrence of, of mental illness and, and is it really as bad

Shawn Singh: as people are saying yes, it is bad?

Cuz a lot of times the, almost always the mental illness that you really are trying to remediate. Is triggered by some underlying trauma and or could be a series a domino effect of different traumas that people have to experience that disrupt their routine. That, you know, if we all knew Covid was going to end at a fixed time, , we could probably muscle through it with a lot different mindset than has been the case.

Not really knowing, especially in the early innings of Covid. So anything that that [00:10:00] disrupts your routine is going to impair many people's ability to. to deal with their daily lives. And that disruption causes the anxiety, which can then lead to the depression, which then has a match set effect and sometimes leads to suicidality.

And that's the thing we really have to keep in mind. These mental illnesses, they're deadly. The suicide rates are, are scary that we've seen increase, especially in youth during the pandemic. But I, I guess I could say this though. You know, the president also mentioned in that State of the Union address that Covid no longer controls our lives.

And I think that's in large part true. for many Americans that are re-engaging in school and work and just about every other walk of life, that's a relief. But for Americans with social anxiety disorder, for example, that's anxiety provoking. And as we start to see people go back to work, go back to school be put in [00:11:00] situations where they've got to interact with people, that's that's scary.

That's scary for social anxiety. Person person affected by that disorder who is worried about being judged or humiliated or embarrassed in what most people consider and can handle as ordinary everyday situations. But if you are worried about being called on in a classroom or you're worried about.

Presenting to your colleagues in a team meeting at work, or if you're anxious about talking to your boss about a promotion, or you're unwilling to pursue, you know, academic advancement. Those are affecting lives, lots of lives. And so the Covid Pandemic on the one hand Caused a lot of distress when there was loss of life, loss of job loss of of housing, loss of a lot of different things.

But it's, it's it's a mixed bag. You know, there are definitely some, some people that were affected specifically by the [00:12:00] pandemic and their mental illness was affected by the trauma induced by the impact of the pandemic. But there's also people who. Tremendously affected by the re-engagement on the other side of the pandemic.

Now that it's a little bit more under control. A lot more under control.

Kevin Folta: Yeah. So you mentioned that a rising prevalence increased surveillance were more sensitive to this happening. We're getting rid of the stigma around it, but then we have these acute events like Covid and returned from Covid, which are inducing even greater prevalence.

Unveiling mental illness, but then you mentioned all of our pharmaceutical interventions are kind of old and what's new? I mean, are there, you see these ads on TV and stuff, but are, is the major battery that we use to approach these issues? Still old pharmaceutical

Shawn Singh: agents. Very much so. They're decades old and, and they're really attempting to be one size fits all approaches to, to treating mental health.

And you know, one comment back on that [00:13:00] last topic we were on, which I think is important to remember too, and because I think is. These were traumas that induced some of the mental illness and mental unhealth, if you will, that we saw over the last few years. The civil unrest, the political unrest, the geopolitical unrest, the economic unrest.

These were things detached from the pandemic. That we've seen in this country over the last few years, which I think also have contributed to these alarming increases in the prevalence of a very significant anxiety and depression disorders and, and to a, a certain extent also other mental health issues.

But those two, and then suicide on the third end of that. That match set. Those are what's troubling me and that's what's troubling our company. It's what's troubling the people out there that are practitioners that are leaning on medications, old school antidepressants that take a long time to, to give you a signal about whether they're going to work or not.

All along the [00:14:00] way, you have to deal with the side effects that are associated with them, and if you are the lucky winner, great because there's no questions. Certain people can be. But many don't. We have a one in three chance of those drugs working. These are the old SSRIs and the SNRIs. If you start taking them for the first time, that leaves a lot of people without any benefit yet they deal with the side effects, trying to see if they get that.

So a long onset of action to tell you whether you're going to have a therapeutic benefit is one. Having to embrace the side effect profiles of these drugs that are generally all oral and delivered systemically throughout your body and have potential impacts on other parts and other medications that you might have to take.

Those are two big problems. And there are other classes of medications, let's say, for anxiety, benzodiazepines, benzos a tremendous problem and worry there. We have a benzo epidemic in this. The F d A came out with[00:15:00] what's called the drug safety communication during covid about benzodiazepines and the misuse, overuse, abuse of those drugs that are really causing amazing challenges right now, especially.

If they, even if you try to stop using them, the withdrawal effort is, is very traumatic in and of itself. So those medications that have been typically leaned into, we really need to depart from many of them in many ways. And that's, that's the mission we've got here at VistaGen, is to focus on what are fundamentally differentiated, we call the mechanisms of action or the way that a drug works.

And that's an important part of why we are excited and confident about what we're working on is because they do work differently than existing drugs. And so what we've seen so far is using the using the nose really as a portal to, to generate [00:16:00] behavioral changes that can improve people's lives.

That's the.

Kevin Folta: Perfect. And that's a great place to leave it off. We've got a problem and the solution can also be a problem. So we need a new kind of solution that may be dependent on the nose. So this is Collaborates talking Biotech podcast. We're speaking with Sean Singh, he's the c e O of VistaGen. And on the other side of the break we'll talk about Vistage's approach that that is really rather novel.

And this is the Talking Biotech podcast and we'll be back in just a. And now we're back on the Talking Biotech podcast. We're speaking with Sean Singh. He's the c e O of VistaGen, and we're talking about new approaches to treating mental health. And before the break, we talked about the problem of mental health and how it's increasing in prevalence and how the existing strategies to solve it fall short and even have problems within themselves.

Now, the idea from VistaGen. They're drugs [00:17:00] that are delivered as nasal sprays. I'm guessing that the nose may be some di sort of direct conduit into the central nervous system. Where these problems begin

Shawn Singh: is, is it really the, like that that's it. You're absolutely right. The, the olfactory bulb, which is at the base of the brain, has direct connections to the part of the brain called the amygdala, which is the main fear and anxiety center of the brain.

That's where overactivity. Can lead to a, an enhanced fear response and higher levels of anxiety. Lower activity may lead to apathy or lethargy or social withdrawal. So enhancing that olfactory amygdala neural circuit may lead to reduced anxiety and depression. So different. We have two different approaches because obviously you're looking at two different.

End results. One is an anti-anxiety or an inhibitory effect, and the other is an antidepressant or stimulatory effect. Okay. So

Kevin Folta: are these getting there because they match with two [00:18:00] different types of receptors. So the G-protein couple receptors all over the olfactory system or these are specific receptors that help us smell and and taste.

And are there specific ones that you're tweaking with specific compounds that are talking

Shawn Singh: to the Amy? , you're right on it. Eventually they end up with it's almost like a telephone tag game, right? So the, the receptors for what are called chemos sensory neurons are only in your nose. And it's that's why we have these drugs formulated as nasal sprays.

And one of the big benefits that we've got with these two drugs, one for depression and one for anxiety, is that at microgram level doses, not milligrams, but microgram levels, We're spraying the, the active drug directly on top of those chemos sensors neuron receptors. Those then broadcast forward to one inter neuron, the olfactory bulb neuron at the base of the brain, which then broadcast forward to the amygdala.

And then there's gaba [00:19:00] GABAergic activity in the amygdala associated with the anti-anxiety effect we're trying to achieve. But you have a very short distance that you're travel. You know, from that mid septum of the nose to and not without having to actually get directly in the brain on top of c n s neurons.

So it's neuro circuitry that we kick into gear when the drug is dropped directly on top of the receptor for those chemos sensory neurons that have subsets of neurons in the olfactory bulb that then connect to the activity we wanna see in the amygdala. So you don't have a drug like a. That as you know, you take orally, it gets digested.

It cruises through your liver, your kidney, your blood. It gets up to your blood-brain barrier. It's gotta go in, figure out where it wants to go and not where you don't want it to go. So we don't have that kind of systemic uptake required to get the behavioral effect that we've seen in phase two studies so far.

The [00:20:00] other important part again, is that we're not we don't have drugs that bind to. The typical receptors that are, for example, associated with abuse, liability, dopamine, nicotine, opiate receptors. So the ability to be able to direct that neural circuitry just to the spot where we want to see activity and not off-target is a very important aspect of the way these drugs were designed to achieve that effect.

And with the rapid onset effect. So we're not talking about weeks pH 94 B. , what we've seen in phase two studies is in effect within about 15 minutes. So that is much different than a pill that you have to take to see systemic uptake and activity. Same thing with pH 10 again, rapid onset. We're not talking about six to eight weeks, but it could be days a week, let's say.

So much faster to see a signal of a therapeutic effect than what you [00:21:00] currently see. In the arena with current antidepressants and anxiolytics. And most importantly too, you're not seeing a side effect profile that carries with it a risk of addiction and And drug drug interaction, things that are associated with systemic medications that people often don't want to take.

And if they do, sometimes they're only taking it for a short period of time. That, and that leaves a lot of untreated folks. And we, we've

Kevin Folta: had a little bit of an alphabet soup of different compounds that we're talking about here. So let's go after them one by one. What is pH 94 B and how does it

Shawn Singh: work?

So think about a rescue inhaler for asthma. Or a migraine drug. The rapid onset on an as needed basis is the, is one of the key hallmarks of pH 94 B. That's a nasal spray. It's fast acting. It's odorless. It's tasteless. It's in a class of drugs called phen, and those are [00:22:00] administered, as I noted, intranasally at microgram doses because that's where the receptors are.

You could drink the drug iv, inject it. It's not gonna do anything. What you need to do is get to the receptors that actually can activate the neuro circuitry. We're trying. Kick into gear to generate the behavioral effect that we've seen in, in development so far. So we have fast track designation for this drug and it's again, it's a, a phin and it's a neuroactive steroid, we call it that.

That when administered intranasally kicks into gear chemos sensors, neurons, that then project to the olfactory bulb and then begin project to the amygdala, pH 10. That is again, like pH 94 B, focused on the psychiatric arena, the neuropsychiatric arena, and this one is focused on depression. So again, similar to pH 94 B, it's a nasal spray.

It's sprayed directly on top of chemos sensory neuron [00:23:00] receptors. A different subset. Likely, we haven't fully cloned this receptor, but we know there's a different subset of chemos censory receptors that Have an affinity for pH 10 that project to a different subset of olfactory bulb neurons, but still olfactory bulb, inter neurons like pH 94 B.

Does that then project forward to the amygdala and a couple other parts of the brain. So that's generating the opposite effect of 94 B. That's a stimulatory or an antidepressant effect. That's our goal with that drug. But again, rapid onset meaning it's not taking. Six to eight weeks to see if there's any potential therapeutic effect.

We've seen it in about a week and likely in phase two B, we'll see it hopefully even earlier than a week and have that benefit sustained. The difference too is that pH 94 B is used when you need it, just like a rescue inhaler, when an asthma attack comes on you. So before an anxiety provoking.[00:24:00]

Event, whether it's a performance event at work or school or a social event could be, you know, the diversity of things situations that trigger. social anxiety disorder for people is incredibly broad and diverse, but it's before those events where people need confidence to engage in those events and not avoid them and to not have fear and anxiety about them.

And with pH 94 B being used as needed in front of those particular events, what you're trying to do is bring people down to. A normal level of anxiety. Everybody needs some anxiety to be energized and focused, but you, you don't wanna put 'em to sleep. And obviously you don't wanna leave them at a very heightened state where their ability to function and engage is impaired.

pH 10. Differently. We, we see that being dosed on a more of a regular basis daily over time because that's the way depression manifests. It's not always [00:25:00] acute. It more waxes and wanes. But say social anxiety disorder, it's episodic. And while some days you may have no events and other days you may have four different events at different times of the day.

And so the flexibility for pH 94 B is that it can be used multiple times a day in studies so far. And and it's got a rapid onset and a short duration of effect. But unlike say, a benzodiazepine won't put you to sleep won't impair your functioning, you're not gonna have a, a cognitive impairment.

You're not going to see a risk of addiction. One of the important things we did with FDA so far was show them all of our data on safety. And one of the things you need to do sometimes is. Do what's called a human abuse potential study, and especially if something is in the psychiatric arena, many drugs are controlled substances and scheduled drugs, and [00:26:00] our belief is the profile from pH 94 B thus far in hundreds of patients.

Has shown no potential for that kind of abuse liability that is worrisome with respect to other drugs. So again, a key hallmark always is to establish the safety profile as well as the efficacy and. We think we're on the right track for that. So the

Kevin Folta: thing that still might not be really clear for me, thinking about the mechanism mm-hmm.

are these binding to specific receptors or are these kind of impeding the constellation of G-protein coupled receptors, which are the major ones involved

Shawn Singh: in olfaction. Yeah. They're binding to specific chemo receptors for specific chemos sensors, neurons. So they're specific to chemos censory neuron.

And the receptors for those neurons which again, because they're only in the nose. You need to, you need to formulate the drug in a way that can get to those receptors in the best way we have, and they're really, the only way to get them to [00:27:00] work is through the nasal spray. So again, the nose being you, you know it's similar but not exactly the same.

Right? You can tell the difference when you. Smell fresh bread versus when you smell raw sewage, you're, there's different signals and messages sent to your brain. It's not exactly the same, but it is, it is similar in that we're trying to trigger neurocircuitry that delivers an intended behavioral effect in via the amygdala the end of the day.

And doing that without having to go into the brain with the drug is, is key, especially to the safety profile. And,

Kevin Folta: and with respect to the safety profile, we spoke about the idea that this is non-systemic, so you decrease the likelihood of drug interactions. You're using tiny amounts, so you're have very little pharmacology happening outside of the target.

And one of the interesting things I read about was potentially in the treatment of postpartum depression, where you have mothers that are breastfeeding who can really only select from a. [00:28:00] Thin number of therapies for anything, let alone depression. So, th that was a really good application of this. Is there any other non-systemic applications that are particularly attractive?

Shawn Singh: Well, you hit one for sure. Postpartum depression as well as postpartum anxiety. As I mentioned earlier, the drug, because it's dosed, it's dosed at microgram levels and is able to achieve that effect. And because it's dosed. on top of the receptors, you can get away with those microgram levels. The typical Advil, as you know, is like 200 milligrams.

So this is a, it's a fundamentally different way of delivering drugs right on top of the receptors that you need to be activating here. But postpartum anxiety also lots of. Of new mom, 17% or so of new mother's battle anxiety. I think it's even higher than that. And postpartum depression, of course.

Similar consequences from what you know, it's a positive [00:29:00] event, but positive events also can be traumatic and can generate mental illness that needs attention. and certainly they don't, moms don't really want to lean into substances that they fear could harm their child. And we have not yet done a study in breast milk to see if the drug is detectable, but it seems likely given that it's not detectable in plasma, that you're not gonna see it, you're, you're not going to see it in breast milk either.

But those definitely are two. Two areas of interest where we think a drug like pH 94 B and pH 10, those could each make a difference in each of those two arena. And what does

Kevin Folta: the timing of these look like in terms of clinical trials or potential time when this may be a reality for

Shawn Singh: people to actually use?

Hmm. You know, the drug development pathways along and winding road sometimes with detours along the way. The answer is, you [00:30:00] know, we, it depends on how late stage studies go. For pH 94 B, our objective would be sometime in the. Innings of 2025 to submit our a new drug application for pH 94 B for social anxiety disorder pH 10 s behind it by a couple years it's entering into a, a phase two B.

Development arena near the end of this year. So, you know, we'll do things as efficiently as we can. It's not always easy. Smaller companies have other factors that they have to bring into play, especially as to funding. But there is a, there's a lot of excitement internally and across the spectrum of practitioners that we talked to as well as patients that we've gone out.

Profiled these, these assets. So we'll do the best we can do and get 'em out as soon as possible. There's no, not only to adults, but to pediatric populations where the need is tremendously acute as well. And each of our adult programs [00:31:00] is also married with a pediatric program. And as I mentioned, a lot of the onset of these mental health disorders takes place in that adolescent phase as young as eight.

And is often between eight and 17. We see typically for social anxiety disorder and with a mean duration of the illness of about 20 years. So it's a chronic disorder in different phases of the journey, but unfortunately it's something that really needs attention and needs attention with way better medications than we've got today.

Combined with expertise talk therapy where the, the patient can be met at their. With someone who has empathy for true empathy that the speaker can understand to get effective talk therapy as, as an amplifier to whatever the medication can deliver.

Kevin Folta: Yeah. The thing with novel technologies that I'm always concerned about is access.

And this becomes [00:32:00] really difficult in this situation because if this does become standard of care, would it likely be covered by insurance for the average person? Because insurance companies are always going to fall back on cheap drugs and traditional therapies and maybe talk therapy over. Novel pharmaceutical intervention.

So does this seem like something that that will be another road that your company would have

Shawn Singh: to navigate? It's always a road, no question about it. No one gets to avoid that pathway, but there will always be a place for older generics that's a well established maxim. But the other part of it is that so many people are clearly not getting the relief that they need from the current options.

And insurers have typically been far more open to innovation in mental health. So given the rapid acting and non-systemic nature of our PR product candidates I, we see them really as first line therapies for many patients. [00:33:00] So compared with other new treatments, That we've seen, which have specific safety related issues associated with them.

Very complicated wait times in offices. Very complicated medical disclosure disposal procedures, things that just can't actually be embraced by a lot of psychiatric practices. We, we see a very simple fit here, and if the safety profile continues to be what it is, and we see rapid onset activity and people getting back to the life.

They have envisioned for themselves and they're active and they're productive. I we're not worried about the insurance companies embracing that. We've already gone out and done some racial groundwork with payers and and see a place for what we've got and, and I think the key is again, the. As you noted, whether the be insurance or payer embrace, and that has a lot to do with how what you're bringing to the market [00:34:00] is differentiated from what is already available at a cheaper price.

And these are not medications that we're developing that are gonna be priced to the moon either. That's just not the way, that's not the prevailing way. There are so many people affected by these disorders. We need to make them accessible across all demographics, all communities because that's how mental illness is affecting people.

There's, there's a broad demographic distribution, there's a broad community-based distribution. That needs help. So that's our core goal, which just to radically improve mental health and wellbeing worldwide because we know there's problems and challenges worldwide, especially with anxiety and depression.

And that's our commitment. I mean, we're, we're developing products that are designed to make a meaningful difference in the way that people who think. Their life is impossible and to try to make their life possible and the way they envision it is a [00:35:00] really. Energizing component of our mission.

And we all know one way or another, someone directly or indirectly that's affected by mental illness and can even imagine those people becoming productive members in the way they want to be in their lives. What a. What an amazing change that would be , what we've got in this country. So one mind at a time is our objective here.

Well, that's a really nice way to

Kevin Folta: put a bow on this. Thank you very much for talking about this. So if people wanted to learn more about this particular topic, where would they look?

Shawn Singh: Well first Kevin, thanks a lot for having me on today. I really appreciate being able to share some of our thoughts and our objectives and especially our goal to ensure equitable access for our product candidates.

Should we be so fortunate to get 'em approved to learn more for sure. Visit our website vistagen.com, and we have all the social, the normal socials Twitter and the like. So we look forward. [00:36:00] Having a chance to speak with you as we continue to progress in these programs that we think can make a massive difference in the way people are able to live their lives in our country and across the world.

Kevin Folta: No. Very good. And I hope that when you have big breakthroughs, you use this conduit again, then inform us about what's going on. It's a really cool novel therapy. Really like that. So Sean saying thank you very much for joining me

Shawn Singh: today on the podcast. My pleasure.

Kevin Folta: And stick around for one quick second here.

And as always, thank you for listening to The Talking Biotech podcast. Write a review on iTunes, tell a friend, and what's really cool is that our listenership continues to grow. And while there's many options now for podcast content, our talking biotech audience gets bigger. All the time. That's really cool because it's people like you that are sharing the new innovations that get us excited about the future.

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