Eleusis SPAC
Third Party Oral Psilocybin Proof of Concept Studies in MDD and Treatment Resistant Depression (TRD)
Rapid, robust, and durable efficacy observed
MDD Clinical Study: Psilocybin (25mg) vs. Escitalopram¹
Met Primary Endpoint
No statistically significant difference in QIDS-
SR-16 depression score at 6 weeks, but
assessments favored psilocybin²
Secondary outcomes²
Mean Change
(QIDS-SR-16 Score)
include:
MADRS:
HAM-D-17:
-14.4 vs -7.2 -10.5 vs -5.1
0.0-
-2.5-
-5.0-
-7.5-
-10.0-
0
7
"A series of studies by Carhart-Harris and
colleagues...provide tantalizing evidence for the
efficacy of psilocybin in the treatment of major
depressive disorder" 3
Prof Jeffery Lieberman, Columbia University
Psilocybin
14
21
Day
Escitalopram
28
35
H
42
-
LS mean change from baseline in MADRS total score
MADRS: -6.6
"We now have evidence from a large well-designed trial
that psilocybin may be effective for people with
(p<.001; 25mg vs 1mg) treatment-resistant major depressive disorder” 5
-8
-10
-12
-14
but significant room for improvement
-16
TRD Phase IIb Study: Psilocybin (25mg, 10mg, 1mg)4
Significant Effect from Day 2 to Week 6
Reported in Third Party Topline Data Release
Day-1
Prof David Hellerstein, Principal Investigator, Columbia University
Day 2
*
Week 1
Week 6
COMP360 25mg --COMP360 10mg -COMP360 1mg
Baseline mean (SD): 25mg (n=79) = 31.9 (5.41); 10mg (n=75)= 33.0 (6.31); 1mg (n=79) = 32.7 (6.24)
Week 3: 25mg Diff = -6.6, p = <0.001
vs 1mg 10mg Diff = -2.5, p = 0.184
Week 3
Week 9
Week 12
Source: 1) Carhart-Harris et al. (2021). Trial of Psilocybin versus Escitalopram for Depression. New England Journal of Medicine, 384(15), 1402-1411; psilocybin dosing at day 0, 21; escitalopram group received 2 separate doses of 1 mg of
psilocybin plus daily escitalopram 2) As per Carhart-Harris et al. (2021), statistical significance assessments not conducted other than for primary endpoint at 6-week timepoint, and no correction for multiple comparisons of the outcomes was
conducted at any intermediate time points, so no clinical conclusions can be drawn. 3) Lieberman, J. (2021) Back to the Future - The Therapeutic Potential of Psychedelic Drugs, NEJM 384,15.4_15_2021; 4) COMPASS Pathways Press Release,
11/9/2021; and COMPASS Pathways Phase IIb Trial Presentation 11/9/20215) https://www.columbiapsychiatry.org/news/psilocybin-found-rapidly-improve-depressive-symptoms-clinical-trial
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