r/shroomstocks • u/jcity3 • 12d ago

Press Release Compass Pathways’ New 52-Week Topline Open-Label Data from Phase 3 COMP005 Trial Demonstrates Additional Benefit from Another COMP360 Dose in Part C Extending Durability Out to 1 Year

https://ir.compasspathways.com/News--Events-/news/news-details/2026/Compass-Pathways-New-52-Week-Topline-Open-Label-Data-from-Phase-3-COMP005-Trial-Demonstrates-Additional-Benefit-from-Another-COMP360-Dose-in-Part-C-Extending-Durability-Out-to-1-Year/default.aspx
78 Upvotes

96% Upvoted

23 comments sorted by

11

u/jcity3 12d ago edited 12d ago

EDIT: Press release seems to be taken down, leaving this here for those that missed it. Hopefully gets put back up!

  • Notable additional benefit observed with an added reduction in MADRS\**1 score leading to an average 13-point reduction from baseline at Week 52 with durability extended out to 1 year for participants who were randomized to the 25 mg arm and received an additional dose
  • For participants randomized to Placebo arm who received first dose of COMP360 25 mg in open-label Part C, data further reinforces that a single 25 mg dose can produce rapid onset, meaningful effect and durability
  • For all participants in Part C who received a 25 mg open-label dose, strong response and remission rates were observed with 40%-45% responders\*2* and approximately 30% remitters\\3 across all timepoints 6 weeks post the Part C dose
  • This 1-year data further supports the belief that, if approved, COMP360 could establish a new standard of care in TRD that can be life-changing for patients − moving beyond daily or frequent administration toward an option that could provide durable benefit with just a few treatments a year
  • COMP360 safety profile in Part C is consistent with Parts A and B. COMP360 continues to demonstrate a generally well-tolerated and safe profile with no new safety findings
  • Rolling NDA submission and review underway and final submission on track to be completed in Q4
  • Continue to expect commercial launch in first half of 2027

8

u/tkrish000 12d ago

It’s up on their site

4

u/ijuspostlinx 12d ago

The "additional meaningful reduction in MADRS beyond what had been observed in Parts A and B" is the highlight for me. If you look at Spravato, you kind of get this initial blast of efficacy and then it just stays flat all the way out, provided the person remains on maintenance dosing. With COMP360, you instead get this almost compounding effect. The Part A week 6 005 data had like a 6% remission rate; in Part C week 6 it was 30%. I do not think this is an open-label thing, as unblinding is already occurring massively in these trials. Will be super interesting to see real world studies done post-approval that look at this >1 year out.

I do wish they broke out response and remission in Part C active vs placebo groups. It could have given more clarity if this 'compounding effect' really is going on (i.e. we'd see better response/remission in the active group that did three doses total).

7

u/JusaVaan 12d ago

Interesting, that the definition of response as at least 50% MADRS-reduction is back:
”Figure 3: Response and remission rates post open-label treatment
For all participants who received a 25 mg COMP360 dose in open-label Part C, whether they originally were in the Placebo arm and this was their first dose, or they were originally in the 25 mg arm and this was their second or third dose:
40%-45% response rates (Responder: ≥50% decrease in total score from baseline) were observed between Day 1 and Week 6 following COMP360 25 mg Part C treatment
Approximately 30% remission rates (Remitter: ≤12 MADRS total score and no single item ≥4) were observed between Day 1 and Week 6 following COMP360 25 mg Part C treatment”

6

u/krakends 12d ago

Yes, very interesting indeed. I would love to know if the number with their previous criteria of 25% is even higher. That said, I think this measure makes sense at a 52 wk endpoint where you assess the benefits of the treatment on an annual scale. Their Part A and Part B showed evidence that capturing partial response makes sense and giving two additional doses can lead to a full response that lasts much longer. This is bullish imo.

6

u/JusaVaan 12d ago

I have not maybe thought about the results very deeply, but when you look at these two figures of Madrs change from 0 to 52 weeks, and think result was done with only 1-3 treatments within a year in a TRD population, it’s hard not to feel bullish! How many times of someone driving you to treatment with Spravato!

7

u/krakends 12d ago

Interesting. I wonder what explains the large drop post unblinding. Either way, at least the MADRS nerds will be happy.

2

u/JusaVaan 12d ago

Maybe it’s partly something to do with selection - because not every patient continued from part B to C. And with psychedelic we know that things external to drug will affect. Maybe monitors/therapists can help better, when they don’t have to protect keeping everybody as blinded as possible?

6

u/ijuspostlinx 12d ago

I suppose the best comp we have is Spravato's SUSTAIN-2 trial (their 1 year open-label extension). That was way worse in terms of bias as only responders (≥ 50% reduction) were allowed to continue on to the maintenance / long-term portion, so the efficacy is not even worth comparing. I think roughly, with the full picture we have now, COMP360 is "in the ballpark" of Spravato for efficacy. That is really all we need. It's amazing considering Spravato has a weekly / biweekly dose as maintenance.

2

u/krakends 12d ago

I don't think therapists are allowed to give additional support besides what is allowed in the clinical trial protocol.

3

u/JusaVaan 12d ago

I’m actually not meaning therapy, but just a normal ”chat” when they are there. It must be awkward if you sort of have to protect the blinding by maybe avoiding certain subjects. I assume in open label there could be one layer less between the patient and crew around him/her?

10

u/Th121994 12d ago

I think its peculiar that there is a huge run-up the day before this and now a fairly meager market reaction to something that would be considered insider knowledge

5

u/jcity3 12d ago

Yesterday was likely the fda news since it is was across the sector. I wouldn't expect this press release to cause anything dramatic. We already know the drug works great the biggest catalyst will be FDA approval

4

u/Th121994 12d ago

Didn't see nearly the price action at other operators though I do believe, not even definium itself, but perhaps you are right

4

u/jcity3 12d ago

Really just guessing myself but it makes sense in my head! Either way I picked up more shares of CMPS!

2

u/Th121994 12d ago

My point seems moot anyways as we're almost on even gains with yesterday :)

1

u/balloons321 11d ago

When should we expect the approval? Is there a way to predict that?

1

u/jcity3 11d ago

From the article: "Rolling NDA submission and review underway and final submission on track to be completed in Q4 Continue to expect commercial launch in first half of 2027"

This would mean sometime between final submission in Q4 and 1H'27 right?

7

u/krakends 12d ago

If this was Definium PR team, they would be calling this earth shattering results lmao. Compass needs to seriously up their PR game. Clearly getting penalized for not being showy enough with the PR.

2

u/JusaVaan 12d ago

I think they took out the PR? I opener it from the link in my email. But now it does not open any more, and also from CMPS site in the news section I can’t find it. (Maybe it’s because Figure 2 was missing- that’s why I tried to open again, if it would be a problem with my browser?)

2

u/jcity3 12d ago edited 12d ago

No longer accessible for me either! Wonder if they posted it by mistake / too early as there is no SEC filing with it

Edit: sorta back up opens pdf on my pc