Compass Pathways Eyes FDA Approval for Psilocybin Depression Drug

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00:00Tell us what's changed since you were in our studios in July.

00:03Thank you. So we're excited about the fact that we're now in a position to potentially accelerate

00:08getting this medicine to patients who so urgently need it. Let me remind you that there are three

00:13million patients living with persistent depression in the U.S. Fewer than five percent of them today

00:19are treated with a medicine that was actually specifically studied for or is approved for

00:25treatment-resistant depression. And this is depression that is chronic, it's refractory,

00:30often people are unable to work. It has dramatic direct health care costs in terms of costs of

00:36emergency room admissions, in psychiatric care, but it also has real social costs for these people.

00:43So what's changed is we've had a really excellent conversation with the FDA about their desire to

00:49see, subject to us continuing to produce really strong results in terms of efficacy and safety,

00:55their desire to see this moved more quickly. We've completed the enrollment in our second

01:00final stage study, which we did ahead of expectations, which is really down to the great...

01:04So this is a phase three?

01:05This is a phase three. This is the second of our final stage studies. We've completed the

01:10enrollment of that. We expect to have the primary data from that in first quarter of next year.

01:15That will give us the second of our final stage studies. And with that, we are actually excited

01:20to be able to submit that to the agency and look to an accelerated approval.

01:24Wow. That sounds like a really big move. I'm curious, just remind us, and we were talking

01:29with our health care team, how you guys designed the trials or research program to avoid some of

01:34the pitfalls that we've seen with, I think about the ecstasy and the MDMA drug application that was

01:41for PTSD. How did you guys avoid some of those pitfalls?

01:45So first, we had the opportunity to learn from some of the lessons. We've been in an excellent

01:52dialogue with the FDA now for some six or seven years since we first started this, since this

01:56process. Yeah. As we know, developing new medicines takes a long time and a lot of commitment.

02:01Yeah. We've done this in a very robust and rigorous way. We are collecting full side effect data. We're

02:08collecting all the issues, not just potential side effects such as headache and fatigue, which are

02:14transient, but also things like liking and so on to make sure that there is really no abuse potential

02:20for this. And we've been collecting that right from the get-go. Is there any abuse potential for this?

02:23There is no history in psilocybin of people actually seeking it out or any abuse potential

02:28with psilocybin, which is an important point. I'm putting my investor hat on for a moment and I need

02:33to ask you about intellectual property and how you handle something like that because psychedelic

02:37compounds don't sort of fit comfortably into that compound, if you will, because a lot of them are

02:43natural. They can't really be patented, if you will. So how do you deal with that and to what extent

02:48is your medicine hold patents or have intellectual property? So our medicine, Comp360, is a fully

02:55synthetic formulation of psilocybin. Okay. We have polyformal patents that address that and therefore

03:02we have robust protection until 2038 with the potential for extension around that because, again,

03:07we went for a fully synthetic modern medicine. Have you talked directly with the Health and Human

03:14Secretary Robert F. Kennedy? We are focused on an excellent relationship with the psychiatry

03:21division of the FDA. Okay. We've been working with the same folks for seven years. Because he has

03:25certainly made some commentary around this that has given, you know, hopes and expectations that this

03:30would move along more rapidly. We're happy that there are senior figures in the administration who

03:35believe like us in the potential for psychedelic therapy, but we're really focused on delivering the

03:41right efficacy and safety through our studies and working directly with the division that's

03:46going to approve us. So trial three, third phase next year, early next year, give us an idea of a

03:52timeline. I mean, when might we see something like this come to market? We will get the primary data,

03:58as I said, in first quarter of next year. Right. We will need to submit some more data later in the

04:03year. But we are looking forward to being in a position to complete a submission to the FDA

04:08in the latter part of next year. And then we'll work with them as expeditiously as possible on a

04:12potential regulatory approval. So, um, 2026, 2027, like what's, I know this stuff all takes long and

04:19I know we constantly am asking you, but I think because it's been so much out there for a while,

04:25a decade and then some, right? I think we're all trying to certainly for an investing audience

04:30understand when this actually hits, hits the market. We are preparing to be ready for a commercial

04:35launch from the end of 2026. Ah, he said it. Well, thank you. What is something like this?

04:41Yeah. What is something like this cost? That's the question. So it's premature to discuss the

04:45pricing for this at the moment. First, we actually still need to see some of the longer term results

04:50from our studies. Right. In particular, we need to see over the course of the first six months,

04:55what the potential for a second dose is and really therefore how many potential sessions that a

05:00patient may need to have in a given year. That's a great question because you're talking sessions.

05:05So this is not a drug that someone would continue to take or a lifelong sort of drug, if you will.

05:13Absolutely. And it's a really important point there. What we have shown in our studies so far

05:17is that a single session can produce a dramatic response that lasts for six weeks.

05:24Today, either it's a daily oral or there is a product, esketamine, which you will need to take

05:30maybe 30 to 50 times a year. What we are showing is truly transformative therefore for these

05:36patients with this infrequent sessions. We're talking with Kabir Nath. He's chief executive

05:40officer of Compass Pathways, ticker is CMPS. He's here in our Bloomberg studio, Bloomberg headquarters.

05:46Kabir, one of the things I think about then is if all goes as you anticipate and you've talked about

05:52the market for like who this is for specifically, then do you move on to other uses and other treatments,

05:59whether it's PTSD, whether it's drug addiction? Like, I'm just curious how far you can go with this.

06:06Yes. Thank you, Carol. And we are designing, have in fact already designed and finalized the design

06:12of a study in PTSD. PTSD affects 13 million people in America. And while there's this view that it's

06:20prevalent among veterans and so on, it absolutely is. That's actually only around 15 percent of that

06:26population. Only 15 percent. 15 percent. Actually, 60 percent of people suffering with PTSD are women.

06:32And so this is a very large population. The only two drugs medicines approved for PTSD were approved

06:39in the last century. So this is something new, something different. And so we are very excited

06:45about that. We have designed a study and that we will be kicking that off next year. I want to go back

06:50to the question of price. Sure. What about insurance and how does that play a part in all of this?

06:57From the get-go, Compass was set up in order to ensure broad and equitable access for patients. And

07:02that means the ability to work with insurers, both commercial and government. With the data we've

07:08already shown, as I say, a single administration producing statistically significant reductions in

07:16depressive symptoms after six weeks, we've already started to demonstrate the value that this can

07:21bring to the healthcare system. Patients living with persistent depression frequently end up in the

07:25emergency room. They sometimes have inpatient psychiatric care. There are direct costs to healthcare systems,

07:32and we have already started to demonstrate the value.

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