COMPASS Pathways (NASDAQ: CMPS) is working hard on developing innovative treatments to better help patients with an urgent unmet need. Although further research is still needed to establish its efficacy and safety, the company’s initial findings are promising and they have progressed to a phase 3 program in TRD.
The company’s innovative approach has received FDA Breakthrough Therapy designation in the U.S. and Innovative Licensing and Access Pathway designation in the UK for their investigational COMP360 psilocybin in treatment-resistant depression. Moreover, in late 2021, COMPASS Pathways announced the completion of a randomized, controlled double-blind phase 2b study of investigational COMP360 psilocybin treatment involving 233 patients with TRD in 22 sites across Europe and North America.
The company’s innovative approach has received FDA Breakthrough Therapy designation in the U.S. and Innovative Licensing and Access Pathway designation in the UK for their investigational COMP360 psilocybin in treatment-resistant depression. Moreover, in late 2021, COMPASS Pathways announced the completion of a randomized, controlled double-blind phase 2b study of investigational COMP360 psilocybin treatment involving 233 patients with TRD in 22 sites across Europe and North America.
Category
🗞
NewsTranscript
00:00 Hey everyone, it's Jordan Robertson with Buzzinga and joining me today is Steve Levine, Senior Vice President of Patient Access and Medical Affairs at Compass and Jeff Grammer, Chief Medical Officer at Green Book NeuroHealth Centers. How are you guys?
00:12 Good, thanks for having me.
00:13 Thank you.
00:14 Of course. So starting with Jeff today, can you introduce yourself and tell us what you do for Compass?
00:18 So actually, I don't work for Compass. I work for a company called Green Book TMS NeuroHealth.
00:23 We are one of the largest behavioral health companies in the United States specializing in sort of interventional psychiatry.
00:31 We have 133 centers. We have been working with Compass Pathways as they've continued their pipeline development to try to be that platform for distribution when they finally launch.
00:47 Wonderful. And Steve, how about yourself? Can you introduce yourself and tell us what you do for Compass?
00:50 Good morning, Jordan. Yes, I'm Steve Levine. I am a psychiatrist and I am Senior Vice President for Patient Access and Medical Affairs for Compass Pathways.
00:59 And in that role, I'm focused on should we receive regulatory approval for new options for patients suffering with treatment resistant depression and other mental health conditions with unmet needs to ensure that not only do we have that regulatory approval,
01:17 but patients are able to have access in a broad and equitable way.
01:21 And in my role within medical affairs, translating the data that we generate through our clinical trials into a form that's accessible to mental health care providers out there who are looking for new options for their patients.
01:35 Wonderful. What do you think is the key philosophy behind what Compass does and how does that align with your personal values?
01:40 Compass's mission is to accelerate patient access to evidence based innovation in mental health.
01:46 To Dr. Grammer's point, there are tremendous unmet needs right now for patients suffering with mental health conditions.
01:53 And the current options are modestly effective at best and oftentimes don't address what's most important to patients.
02:02 And so that focus that Compass has on innovation is so critical for these patients in need.
02:08 But beyond that, we have to ensure that we're also creating access.
02:12 Everyone deserves access to high quality mental health care.
02:16 So we need to make sure that not only are we developing innovative new treatments, but that they're able to get to the patients who need to benefit from them.
02:25 Absolutely. And Jeff, back to you. How has mental health care changed over the last 10 years?
02:29 Yeah, I mean, wow, what a revolution, right?
02:32 So traditionally, if you were suffering from something like depression, you would go see a prescribing provider, a nurse practitioner, a psychiatrist.
02:39 They would often prescribe what's called a selective serotonin reuptake inhibitor.
02:43 And if that didn't work, they would break into another class of antidepressants like serotonin norepinephrine reuptake inhibitor.
02:50 And in the end, most of the medications we had were some variation of modulating serotonin norepinephrine, a dopamine transmission within the brain.
03:00 The problem with that is it's sort of one tool for what is most likely what we call a heterogeneous or multiple cause disease state.
03:10 So we think of depression kind of like headache. There's a lot of things that cause headache.
03:15 If you came and saw me for headache and I said, all I got is Tylenol, like that's going to leave you wanting.
03:21 We'll take migraines, for example, that doesn't respond as well to Tylenol.
03:24 Often people need different classes of agents for that.
03:27 So what we're beginning to see is people breaking away from that kind of very rigid model and bringing more tools to the front, if you will,
03:38 to give patients more options to try to address some of those variations in what's causing the disease.
03:45 And so some of this is with direct neural stimulation using non-invasive techniques like transcranial magnetic stimulation.
03:52 But some of this is in medications that have very unique mechanisms of action that directly address some of the causes of depression by either rebalancing certain networks within the brain
04:04 or helping nerves grow new connections to other nerves that often get damaged in depression.
04:09 And so it really is giving us much more flexibility in trying to help our patients.
04:15 I also think we're beginning to see the early signs of personalized medicine in psychiatry, and this is very exciting.
04:22 Some of this is with like genetic testing to look at how quickly you would metabolize certain medications or whether you're more likely to respond to certain medications.
04:30 And there is ongoing work trying to find some sort of functional assessment that will better help predict what treatment a patient may need,
04:38 though that needs a little bit more time to cook before that's ready for prime time.
04:41 And Steve, jumping over to you, how do you believe mental health care will change over the next 10 years?
04:46 Well, building on the innovation that Dr. Gramer was just speaking to, I think we really are on the cusp of some exciting new options for patients
04:55 that will hopefully lead to more rapid acting and better outcomes for patients in need,
05:02 whether that's moving towards biomarkers or other tests that can more personalize treatment for patients and be more predictive of who may benefit from what treatment,
05:12 to having new, better and more options available for treatments.
05:18 I think these are a set of conditions for which we need more than one good new option.
05:23 We need as many tools in the toolbox as possible because the demand is so great for really any of our diagnoses within psychiatry.
05:33 And we're on the cusp of that, whether it's psychedelic treatments and development or other promising new innovations that we will hopefully see approvals for in the coming years,
05:44 as well as the infrastructure that's being built to deliver them, particularly centers that focus on delivering some of our most promising treatments,
05:53 which are the interventional treatments. I think in the coming decade,
05:57 we're going to see this confluence of increased access for patients in need care and better tools to meet those needs coming together to really start to make a difference for these patients.
06:10 And it's so desperately needed because the rate of diagnoses has only been rising.
06:15 The rates of suicide are at all times, the all time highs. In fact, somebody dies of suicide every 40 seconds.
06:22 So there is a tremendous urgent need. Yeah, absolutely.
06:26 And Jeff, what is the single most important thing a doctor can do to help a patient suffering from mental health issues in a clinical setting?
06:33 Yeah, I think it's to Steve's point, you know, we we need to rethink how we approach mental health disease.
06:44 And so the model that's beginning to develop is a lot like that which we see in cardiology,
06:50 where you have some cardiologists who practice in a clinic, they prescribe medications, they'll do some some assessments.
06:57 But if a patient needs angioplasty, for example, they need to refer them to a center that specializes in angioplasty.
07:04 And there are very defined algorithms for when they would do that.
07:11 So in psychiatry, we're beginning to see the same thing.
07:15 So, you know, there was a study that was done years ago at the NIH called the STAR-D trial,
07:20 which basically showed that if you haven't responded to at least four medication trials,
07:27 you are very unlikely to ever respond to a medication, no matter how many more trials you go through.
07:32 OK, and so even the odds after two medication trials start to look increasingly less promising.
07:41 So what we need to think of in psychiatry is not necessarily trying the same thing over and over and over again with different medications,
07:48 but knowing when to off ramp to one of those interventional psychiatry centers.
07:53 Now, those interventional psychiatry centers, again, to what Steve said, also need to have sort of.
08:01 Procedures in place to overcome three obstacles, awareness, geographic proximity and fiscal viability.
08:09 So both providers and patients need to know that that kind of technology exists.
08:14 OK, and it needs to be relatively nearby where people work and live.
08:20 Right. So they're not traveling, like, say, three days to go to a center or something.
08:24 And then, you know, when they get there, we need to have centers that will utilize their health insurance to try to keep costs down
08:32 and really work with the patient so that they're not constrained by the fiscal, you know, sort of limits to that modality.
08:40 But instead, you ease them through that so that they can just focus on getting better.
08:45 Remember, we're talking about a vulnerable population of patients.
08:49 So imposing upon them the burden of overcoming those obstacles isn't entirely fair.
08:56 That needs to be assumed by the center.
08:58 So we now have to have this close coordination between outpatient providers who are doing more of the medication management and psychotherapy
09:07 and these interventional psychiatry centers, and they need to work in concert with one another,
09:12 with a seamless transition between those two for the betterment of our patients.
09:16 Certainly. And Steve, same question.
09:18 What is the single most important thing a doctor can do to help a patient suffering from mental health issues in a clinical setting?
09:23 I fully agree with what Jeff said, and I'll add that we need to listen to patients and we need to listen to what's important to them.
09:32 For too long now, for many decades, the bulk of our treatments have been focused on just reducing symptoms,
09:39 which isn't necessarily what equates to improvement in a patient's quality of life.
09:44 So we need to understand what's really important to patients in their health care and start to develop treatments and approaches to care
09:51 that are a better fit for what actually matters in terms of actually improving the quality of their daily life.
09:58 Well, Steve, Jeff, thank you so much for being here with me today. I appreciate it.
10:02 Thank you for having me.
10:03 Jordan.
10:04 [Music]
10:10 [BLANK_AUDIO]