COMPASS Pathways Plc · NASDAQ:CMPS
COMPASS Pathways — Technical Presentation (November 2021)
15 slides from COMPASS Pathways's technical presentation, Nov 9, 2021
Slide 1: COMP360 psilocybin therapy for treatment-resistant depression
COMP360 psilocybin therapy for treatment-resistant depression Phase IIb topline data 09 November 2021 © COMPASS Pathways plc 2021 PLEASE DO NOT DISTRIBUTE
Slide 2: Disclaimer
Disclaimer This presentation has been prepared by COMPASS Pathways plc (“we,” “us,” “our,” “Compass” or the “Company”) and is made for informational purposes only and does not constitute an offer to sell or a solicitation of an offer to buy securities, nor shall there be any sale of any securities i
Slide 3: Our COMP360 psilocybin therapy
Our COMP360 psilocybin therapy COMP360 COMP360 psilocybin therapy: clinical status Investigational synthetic, high-purity, polymorphic crystalline formulation of psilocybin • Preclinical genotoxicity and cardiotoxicity studies completed or Oral capsules underway • Phase I trial completed: COMP360 ge
Slide 4: COMP 001 study design and endpoints
COMP 001 study design and endpoints 3-6 weeks Day 1 Day 2 Week 1 Week 2 Week 3 Week 12 D1: COMP360 Screening D-1: Baseline psilocybin Day 2 Week 1 Week 2 Week 3 Week 12 (V1) (V2) administration (V4) (V5) (V6) (V7) (EOS*, V10) (V3) Weekly visits (V1a, V1b, etc) for antidepressant Week 6 (V8) Week 9 (
Slide 5: Participant disposition and demographics
Participant disposition and demographics Randomised (n=233) 131 (56%) patients were from Europe, 102 (44%) from Allocation North America 219 (94%) patients had no COMP360 25mg (n=79) COMP360 10mg (n=75) COMP360 1mg (n=79) prior psilocybin experience Follow-up Participant demographics (age, gender, r
Slide 6: Primary endpoint – change from baseline in MADRS total score
Primary endpoint – change from baseline in MADRS total score Statistically significant primary endpoint (p<0.001) at week 3 (25mg vs 1mg). There was a rapid onset of action and durable effects with treatment differences between the 25mg vs 1mg group apparent from the day after COMP360 psilocybin adm
Slide 7: Key secondary endpoint - MADRS responders
Key secondary endpoint - MADRS responders 25mg group demonstrated rapid response, with treatment differences from day 2 to week 3 compared with the 1mg group 60 Responder: ≥50% decrease in MADRS total score from baseline 50 36.7% 40 (29/79) 32.9% % responders (26/79) 30 20 10 42 24 18 35 17 12 29 14
Slide 8: Key secondary endpoint - MADRS remitters
Key secondary endpoint - MADRS remitters 25mg group demonstrated rapid remission, with treatment differences from day 2 to week 3 compared with the 1mg group 40 Remitter: MADRS total score ≤ 10 35 29.1% 30 (23/79) 26.6 % (21/79) 25 % remitters 20 15 10 5 30 16 15 25 8 9 23 7 6 20 7 10 16 9 9 21 5 9
Slide 9: MADRS sustained responders at week 12
MADRS sustained responders at week 12 Higher proportion of sustained responders found in the 25mg vs 1mg arm 30 24.1% (19/79) 25 Sustained responder* – patients meeting the MADRS response criteria at week 3 and at week 12, and at least at one visit out of 20 week 6 and week 9, and who did not start
Slide 10: Safety – treatment emergent adverse events (TEAEs) overview
Safety – treatment emergent adverse events (TEAEs) overview • The vast majority of TEAEs (over 90%) were of mild or moderate severity • The proportion of patients reporting a serious TEAE was comparable between the 25mg and 10mg groups: – 5 (6.3%) patients in the 25mg COMP360 arm – 6 (8.0%) patients
Slide 11: Most frequent TEAEs ordered by the 25mg arm
Most frequent TEAEs ordered by the 25mg arm (at least 5% in any treatment group) COMP360 COMP360 COMP360 25mg 10mg 1mg Overall TEAE incidence is MedDRA TEAE preferred term higher in the 25mg N=79 N=75 N=79 N=233 group overall n (%) Headache 27 (34.2) 16 (21.3) 20 (25.3) 63 (27.0) Nausea 18 (22.8) 7
Slide 12: Treatment emergent serious adverse events (TESAEs) ordered by 25mg arm
Treatment emergent serious adverse events (TESAEs) ordered by 25mg arm COMP360 COMP360 COMP360 Overall 19 TESAEs were 25mg 10mg 1mg reported in total, MedDRA preferred term N=79 N=75 N=79 N=233 experienced by 12 Number of patients per category (%) patients Patients with a TESAE 5 (6.3) 6 (8.0) 1 (1.
Slide 13: Largest, randomised, controlled double-blind psilocybin therapy trial shows rapid and sustained response
Largest, randomised, controlled double-blind psilocybin therapy trial shows rapid and sustained response for COMP360 psilocybin therapy • Largest, randomised, controlled, double-blind psilocybin therapy study ever completed shows rapid and sustained response for patients receiving a single 25mg dose
Slide 14: COMP360 psilocybin therapy development moving forward
COMP360 psilocybin therapy development moving forward • Complete final analysis of all data and endpoints to further inform path forward • Hold an end-of-phase II meeting with FDA to discuss topline data and continue discussions around development path and phase III design – Meeting anticipated Q1 2
Slide 15: Thank you for your time Any questions?
Thank you for your time Any questions?
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