psilocybin (COMP360) / Compass Pathways - LARVOL DELTA

Compass Pathways Announces Completion of Recruitment for the Phase 3 COMP005 Trial of COMP360 Psilocybin for Treatment-Resistant Depression (Businesswire) - "Compass Pathways plc...announced the completion of recruitment in the COMP005 phase 3 trial for treatment resistant depression (TRD). The final participants are completing pre-dosing activities, including washout from anti-depressant medications, if necessary, and those eligible will receive a dose of either 25 mg of COMP360 or placebo....Top-line 6-week (primary endpoint) COMP005 data is expected late in the second quarter 2025 and 26-week COMP005 data is expected once all participants in the COMP006 trial have completed part A of the COMP006 trial. The COMP006 26-week data is expected in the second half of 2026."

Enrollment closed • P3 data • Depression

The Safety and Efficacy of Psilocybin in Patients with Treatment-resistant Depression and Chronic Suicidal Ideation (clinicaltrials.gov) - P2 | N=20 | Active, not recruiting | Sponsor: Sheppard Pratt Health System | Recruiting ➔ Active, not recruiting | Trial completion date: Apr 2024 ➔ May 2025 | Trial primary completion date: Apr 2024 ➔ May 2025

Enrollment closed • Trial completion date • Trial primary completion date • CNS Disorders • Depression • Mood Disorders • Psychiatry • Suicidal Ideation

Compass Pathways Announces Publication of Results from COMP004 Study on COMP360 Psilocybin for Treatment-Resistant Depression (Businesswire) - P=Obs | N=66 | COMP004 (NCT04519957) | Sponsor: COMPASS Pathways | "The COMP004 study's findings suggest that over a 52-week period, a single administration of 25 mg COMP360 psilocybin demonstrated a longer maintenance of antidepressant effects compared to the 1 mg and 10 mg doses....Durable improvement in symptoms observed. The analysis of all patients in COMP001 revealed a longer time to relapse for patients receiving 25 mg compared with 10mg and 1 mg, with the median time to a depressive event of 92 days for the 25 mg dose group, 83 days for the 10 mg and 62 days for the 1 mg group. Extended benefit for a subgroup. A post hoc analysis revealed a substantial difference in time to depressive event for those who enrolled in COMP004 from COMP001 in the 25 mg group compared to the 10mg and 1mg groups, with median times of 189 days for the 25 mg group, 43 days for the 10 mg group, and 21 days for the 1 mg group."

Observational data • Depression

Results From a Long-Term Observational Follow-Up Study of a Single Dose of Psilocybin for a Treatment-Resistant Episode of Major Depressive Disorder. (PubMed, J Clin Psychiatry) - P=N/A | "Background: The largest randomized study of psilocybin to date demonstrated the efficacy of COMP360 25 mg (Compass Pathways' investigational proprietary pharmaceutical-grade synthesized psilocybin formulation) in participants with treatment-resistant depression (COMP 001), compared with 10 mg and 1 mg doses...Larger long-term studies are required to confirm these findings and provide clarity on the longer-term effects of psilocybin. Trial Registration: ClinicalTrials.gov identifier: NCT04519957."

Clinical • Journal • Observational data • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry • Suicidal Ideation

Compass Pathways Announces Fourth Quarter and Full-Year 2024 Financial Results and Business Highlights (Businesswire) - "Top-line 6-week (primary endpoint) COMP005 data is on track for the second quarter 2025 and 26-week COMP005 data is expected once all participants in the COMP006 trial have completed part A of the COMP006 trial. The COMP006 26-week data is expected in the second half of 2026."

P3 data • Depression

The role of the psychedelic experience in psilocybin treatment for treatment-resistant depression. (PubMed, J Affect Disord) - "The intensity of psychedelic experience overlaps widely across doses and mitigates the risk of unblinding to dose. Correlations between psychedelic experience and outcome suggest specificity in psilocybin's mechanism of action. Quality and intensity of psychedelic experience may be a measure of pharmacodynamic effect and reveal an effective dose response phenomenon for single oral doses."

Journal • CNS Disorders • Depression • Mood Disorders • Psychiatry

PSILOBSD: Psilocybin rTMS for Treatment Resistant Depression (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: University of Texas at Austin | Trial completion date: May 2028 ➔ Dec 2030 | Trial primary completion date: Mar 2028 ➔ Dec 2029

Trial completion date • Trial primary completion date • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Efficacy and Safety of COMP360 Psilocybin Therapy in Anorexia Nervosa: a Proof-of-concept Study (clinicaltrials.gov) - P2 | N=32 | Completed | Sponsor: COMPASS Pathways | Active, not recruiting ➔ Completed | N=60 ➔ 32

Enrollment change • Trial completion • Anorexia

Efficacy, Safety, and Tolerability of COMP360 in Participants With TRD (clinicaltrials.gov) - P3 | N=255 | Recruiting | Sponsor: COMPASS Pathways | Trial completion date: Jul 2025 ➔ Feb 2026 | Trial primary completion date: Oct 2024 ➔ Feb 2025

Trial completion date • Trial primary completion date • CNS Disorders • Depression • Mood Disorders • Psychiatry

Psilocybin as a novel treatment for chronic pain. (PubMed, Br J Pharmacol) - "Current clinical aspects and the translational potential of psilocybin from animal models to chronic pain patients are reviewed. Also discussed is psilocybin's profile as an ideal anti-nociceptive agent, with a wide range of effects against chronic pain and its associated inflammatory or emotional components."

Journal • Review • CNS Disorders • Depression • Neuralgia • Pain • Psychiatry

PsilOCD: A Pharmacological-Challenge Feasibility Study (clinicaltrials.gov) - P1 | N=19 | Completed | Sponsor: Imperial College London | Recruiting ➔ Completed

Trial completion • Mood Disorders • Obsessive-Compulsive Disorder • Psychiatry

The Effects of Psilocybin on Self-Focus and Self-Related Processing in Major Depressive Disorder (clinicaltrials.gov) - P3 | N=20 | Recruiting | Sponsor: Sharmin Ghaznavi | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

The impact of antidepressant discontinuation prior to treatment with psilocybin for treatment-resistant depression. (PubMed, J Psychiatr Res) - "Data from 233 participants with treatment-resistant depression (TRD) who received 25 mg, 10 mg, or 1 mg of investigational drug COMP360 psilocybin (a proprietary, pharmaceutical-grade synthetic psilocybin formulation, developed by the sponsor, Compass Pathfinder Ltd.), administered with psychological support, were compared for groups of participants who either discontinued one or more antidepressant drugs during screening or entered the trial antidepressant drug free...These findings also support the overall homogeneity of our findings with psilocybin treatment as a monotherapy for TRD. The prior contradictory reports may come to appear misleading."

Journal • CNS Disorders • Depression • Mood Disorders • Psychiatry

The Effects of Psilocybin on Self-Focus and Self-Related Processing in Major Depressive Disorder (clinicaltrials.gov) - P3 | N=20 | Not yet recruiting | Sponsor: Sharmin Ghaznavi | Initiation date: Apr 2024 ➔ Oct 2024

Trial initiation date • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Challenges and opportunities in incorporating serotonergic agonists ("psychedelics") into NbN (ECNP 2024) - "The drugs that are said to produce psychedelic experiences come from various pharmacological classes and include ketamine, MDMA and serotonergic agonists like LSD, psilocybin and related compounds...Given their known pharmacology and the dependence of psychoactive effects on dose, it is also unnecessary. Nevertheless, it remains of interest how far the subjective effects are contributory to any clinical benefit and so will need to be described in the mechanism of action."

CNS Disorders • Depression • Psychiatry • NBN

Efficacy and Safety of COMP360 Psilocybin Therapy in Anorexia Nervosa: a Proof-of-concept Study (clinicaltrials.gov) - P2 | N=60 | Active, not recruiting | Sponsor: COMPASS Pathways | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2024 ➔ Dec 2024 | Trial primary completion date: May 2024 ➔ Nov 2024

Enrollment closed • Trial completion date • Trial primary completion date • Anorexia

Investigational COMP360 psilocybin treatment for treatment-resistant depression: assessing altered states of consciousness (ECNP 2024) - "In keeping with previous literature, these Results suggest that the magnitude of specific psychedelic experiences, are associated with clinical outcomes. Exploration of the 11D-ASC subscales as well as dimensions can provide further insights into aspects of the psychedelic experience that may be relevant to positive treatment outcomes. Psychedelic clinical research should continue to utilize standardized questionnaires to further characterize the quality of psychedelic experiences, including identification of potential factors that may relate to clinically meaningful experiences."

CNS Disorders • Depression • Mood Disorders • Psychiatry

Changes in positive and negative affect in participants with treatment-resistant depression following COMP360 psilocybin treatment (ECNP 2024) - "COMP360 psilocybin 25mg, alongside psychological support, reduced NA whilst increasing PA at Day 2 compared to COMP360 psilocybin 10mg and 1mg, and retained these improvements at 3 weeks post-treatment across several dimensions of PA and NA. Improvements in PA are often overlooked in assessing antidepressant response, which is an important factor for patients, suggesting a potential benefit of COMP360 in the treatment of TRD."

CNS Disorders • Depression • Mood Disorders • Psychiatry

Rapid antidepressant effect of intranasal BPL-003 (5-methoxy-N,N-dimethyltryptamine) in treatment-resistant patients: a phase 2a open label study (ECNP 2024) - P2 | "Several studies have recently demonstrated the beneficial effects of psychedelics, such as COMP360 [1] and GH001 [2] for depression...The mean number of failed antidepressants in the current episode was 3.2 (range of 2-5), with citalopram and sertraline the most frequently failed antidepressants...This indicates a single dose every 3 months or later may be the appropriate dosing regimen. Dose optimisation, to maximise the therapeutic effect is ongoing, with doses up to 12 mg being explored in a Phase 2b TRD study (BPL-003-201)."

Clinical • P2a data • CNS Disorders • Depression • Psychiatry

The Safety and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder (clinicaltrials.gov) - P2 | N=22 | Completed | Sponsor: COMPASS Pathways | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder

Psilocybin: The future of chronic pain treatment? (IASP 2024) - "Our data strongly indicate that a single injection of psilocybin provides long period of relief from neuropathic pain. Our ongoing experiments suggest that these actions may be linked to changes in 5-HT2A receptor levels."

Back Pain • CNS Disorders • Cognitive Disorders • Depression • Developmental Disorders • Fibromyalgia • Immunology • Migraine • Musculoskeletal Pain • Neuralgia • Pain • Peripheral Neuropathic Pain • Psychiatry • Rheumatology

An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD) (clinicaltrials.gov) - P2 | N=27 | Active, not recruiting | Sponsor: Sheppard Pratt Health System | Trial completion date: Oct 2023 ➔ May 2026 | Trial primary completion date: Oct 2023 ➔ Jun 2025

Trial completion date • Trial primary completion date • CNS Disorders • Depression • Mood Disorders • Psychiatry

PSILOBSD: Psilocybin rTMS for Treatment Resistant Depression (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: University of Texas at Austin | Trial completion date: May 2027 ➔ May 2028 | Initiation date: Jun 2024 ➔ Sep 2024 | Trial primary completion date: Mar 2027 ➔ Mar 2028

Trial completion date • Trial initiation date • Trial primary completion date • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Single-Dose Psilocybin for Veterans With Severe Treatment-Resistant Depression: Effects on Anxiety, Functioning, and Quality of Life (ISBD 2024) - " 15 Veterans with TRD received a single 25mg dose of psilocybin (COMP360)... Results from this pilot study suggest that psilocybin may improve anxiety, functioning, and quality of life in some Veterans with severe TRD. Overall improvement in these domains was sustained until 12 months post-dosing, but the size of effects decreased over time. Further research is needed with larger sample sizes and longer study duration."

HEOR • CNS Disorders • Depression • General Anxiety Disorder • Mood Disorders • Psychiatry

Compass Pathways announces durable improvement in symptoms through 12 weeks in open-label phase 2 study of COMP360 psilocybin in post-traumatic stress disorder (GlobeNewswire) - P2 | N=22 | NCT05312151 | Sponsor: COMPASS Pathways | "Compass Pathways plc...announced top-line results from an open-label phase 2 study evaluating the safety and tolerability of investigational COMP360 psilocybin treatment in 22 patients with post-traumatic stress disorder (PTSD). The study met its primary safety endpoint and available secondary efficacy endpoints....Durable improvement in symptoms from baseline observed following a single administration. Improvement in mean CAPS-5 total score from a baseline of 47.5 was observed (29.9 point reduction at week 4 and 29.5 point reduction at week 12). Improvement over time in Sheehan Disability Scale (SDS) measure of functional impairment over 12 weeks. From a mean SDS total score of 22.7 at baseline, there was a 11.7 point reduction at week 4 and a 14.4 point reduction at week 12."

P2 data • CNS Disorders • Post-traumatic Stress Disorder