COMPASS Pathways
🇬🇧United Kingdom
- Country
- 🇬🇧United Kingdom
- Ownership
- Public
- Established
- 2016-06-13
- Employees
- 186
- Market Cap
- -
- Introduction
Compass Pathways Plc is an investment holding company. It operates through its subsidiaries which provide mental health care services. The company was founded by Goldsmith George Jay and Malievaskaia Ekaterina in 2016 and is headquartered in London, the United Kingdom.
Bipolar Depression Market Set to Grow Through 2034 with New Therapies in Pipeline
• The global bipolar depression market is projected to experience significant growth through 2034, driven by increasing prevalence, with the United States accounting for approximately 85% of the market share across major regions.
• Several pharmaceutical companies including NeuroRx, COMPASS Pathways, and Intra-Cellular Therapies are advancing novel treatments, with Johnson & Johnson's recent $14.6 billion acquisition of Intra-Cellular Therapies highlighting industry confidence in the sector.
• Among current therapies, CAPLYTA (lumateperone) is expected to achieve the highest market share by 2034, while emerging treatments like NRX-100/101 and COMP 360 (psilocybin) show promise for addressing unmet needs in bipolar depression management.
Colorado Advances Legislation to Allow FDA-Approved Psilocybin Medications
• Colorado legislators have passed a bill that would permit the prescription and distribution of FDA-approved medications containing psilocybin, potentially expanding mental healthcare options in the state.
• The bipartisan legislation, which passed a House committee with a 6-2 vote, would automatically allow medical use of synthetic psilocybin products upon FDA approval, bypassing Schedule I restrictions.
• While no psilocybin-based pharmaceuticals have yet received FDA approval, several candidates are in late-stage clinical trials for conditions including treatment-resistant depression and PTSD.
MindMed Reports Strong Financial Position and Progress in Anxiety Treatment Development
• MindMed maintains robust financial health with $273.7M cash reserves as of December 2023, ensuring operational funding through 2027 despite reporting Q4 loss of $0.41 per share.
• The company's MM120 ODT program received FDA breakthrough therapy designation for Generalized Anxiety Disorder and expanded into Major Depressive Disorder treatment development.
• MindMed aims to address the needs of over 50 million anxiety and depression patients through Phase 3 GAD and MDD studies planned for 2025.
Compass Pathways Advances Revolutionary Psilocybin Treatment COMP360 into Phase 3 Trials for Treatment-Resistant Depression
• Compass Pathways has launched the largest ever randomized, controlled, double-blind psilocybin treatment clinical program, advancing COMP360 into Phase 3 trials for treatment-resistant depression.
• COMP360, a proprietary synthesized psilocybin formulation, has received both FDA Breakthrough Therapy designation and UK ILAP designation, highlighting its potential therapeutic significance.
• The company's innovative treatment model combines COMP360 administration with psychological support, following successful Phase 2b trials that demonstrated statistically significant results.
5-MeO-DMT Nasal Spray Shows Promise in Phase 2a Alcohol Use Disorder Trial
• A single dose of BPL-003, a synthetic intranasal 5-MeO-DMT formulation, combined with behavioral therapy, significantly reduced alcohol consumption from 9.3 to 2.2 units per day over 12 weeks.
• The Phase 2a trial demonstrated impressive outcomes with 50% of participants maintaining complete abstinence throughout the study period and mean abstinent days increasing from 33% to 81%.
• The treatment showed favorable safety profile with only mild to moderate adverse events and efficient clinical administration, allowing patient discharge within approximately two hours.
Psilocybin Shows Promise in Easing End-of-Life Distress
• Psilocybin-assisted therapy is emerging as a potential treatment for anxiety, depression, and existential distress in patients facing terminal illnesses.
• Studies show that psilocybin can significantly reduce depression and anxiety in cancer patients, with benefits lasting for six months or longer.
• Psilocybin influences the brain's default mode network, reducing rumination and fear of death, and fostering a sense of peace and acceptance.
• The FDA has granted Breakthrough Therapy status to psilocybin for depression-related conditions, accelerating its development and review for potential palliative care applications.
Compass Pathways Announces $150 Million Underwritten Offering to Advance Mental Health Treatments
• Compass Pathways has announced an underwritten offering expected to generate gross proceeds of $150 million, potentially reaching $353 million with warrant exercises.
• The funds will support ongoing Phase 3 trials (COMP005 and COMP006) for treatment-resistant depression, with data expected in 2025 and 2026.
• A portion of the proceeds will also accelerate a late-stage development program focused on addressing post-traumatic stress disorder (PTSD).
• The offering, led by Deep Track Capital, includes participation from new and existing investors, with closing anticipated around January 13, 2025.
Biopharma Industry Faces Continued Layoffs in 2025 Amid Strategic Realignments
• Biopharma companies continue to announce layoffs in 2025, driven by strategic realignments, pipeline reprioritizations, and challenging financial conditions.
• Several companies, including Intellia Therapeutics and IGM Biosciences, are cutting a significant portion of their workforce to focus on key programs and extend cash runways.
• These workforce reductions are often accompanied by discontinuation of certain drug development programs and a shift in strategic focus towards core assets.
• The layoffs reflect a broader trend in the industry as companies adapt to evolving market dynamics and prioritize efficiency and long-term sustainability.
Clearmind Medicine's CMND-100 Receives IRB Approval for AUD Clinical Trial at Yale
• Clearmind Medicine received IRB approval for its Phase I/IIa clinical trial of CMND-100, a novel therapeutic targeting alcohol use disorder (AUD).
• The trial, to be conducted at Yale School of Medicine, will assess the safety, tolerability, and efficacy of CMND-100 in reducing alcohol cravings.
• CMND-100 aims to address the critical gap in AUD treatment, where current options have limited efficacy (less than 30%) and patient compliance.
• Alcohol consumption causes 2.6 million deaths annually worldwide, highlighting the urgent need for effective AUD treatments.
Psychedelic Drug Development Shows Promise Amidst Regulatory and Investment Challenges
• Clinical trials show psilocybin-based therapies are relatively safe and effective for mental health conditions, with Compass Pathways and Cybin advancing to Phase 3 trials.
• The FDA is taking a neutral stance, emphasizing the need to prevent misuse and address psychoactive effects, while insurers remain cautious about coverage.
• Companies are employing composition of matter patents to protect their formulations, with some, like Cybin, holding numerous patents and applications worldwide.
• Despite a market downturn, positive late-stage trial results could renew investor interest, as the industry moves towards traditional pharmaceutical commercialization models.
Psilocybin Shows Promise in Mental Health Treatment Amid Evolving Regulations
• Psilocybin, found in 'magic mushrooms,' shows potential in treating depression, anxiety, and PTSD, with clinical trials indicating significant improvements in symptoms.
• The global mushroom market is experiencing steady growth, projected to reach USD 136 billion by 2032, driven by demand from the food, pharmaceutical, and cosmetics industries.
• Regulations surrounding psilocybin vary globally, with some regions decriminalizing or permitting medical use, while others maintain strict prohibitions.
• Public support for psychedelic therapies is increasing, with a majority favoring medical trials and psilocybin-assisted psychotherapy, though concerns about safety and misuse persist.
CaaMTech Receives Regulatory Validation for Functional Unblinding Strategy in Psilocin Prodrug Trial
• CaaMTech received positive feedback from U.S. regulators for its CT-4201 psilocin prodrug program, which includes a strategy for functional unblinding in clinical trials.
• The validation streamlines the clinical development of CT-4201, a psilocin prodrug with enhanced pharmacokinetics, for treating Major Depressive Disorder (MDD).
• Functional unblinding has emerged as a significant challenge in psychedelic medicine, potentially affecting the approval of drugs like psilocybin.
• CaaMTech's approach aims to address the issue of trial participants discerning whether they received a placebo or the active drug, a hurdle for psychoactive substances.
Cybin's Psychedelic Drug for Depression Advances to Phase 3 Trial Amidst FDA Scrutiny
• Cybin Inc. has received FDA approval to begin Phase 3 trials for its synthetic psilocybin variant (CYB003) to treat major depressive disorder, aiming for results in 2026.
• The FDA's increased scrutiny of psychedelic drug trials, highlighted by setbacks for Lykos Pharmaceuticals and Compass Pathways, has led Cybin to incorporate more stringent safety measures.
• Johnson & Johnson’s Spravato, a ketamine-derived product, is expected to reach blockbuster status, demonstrating the growing infrastructure and acceptance for psychedelic medicines.
• Cybin is implementing measures such as using psychedelic-naïve populations, ensuring overall blinding, and recording trial sessions to address FDA concerns and enhance patient safety.
Neuroscience Investment Surges Amidst Hurdles in Clinical Trials and Diagnosis
• Investment in neuroscience is increasing, driven by emerging treatments and unmet needs in CNS disorders, despite high risks and failure rates.
• A major challenge is the high cost and poor translation of animal models in Phase III trials, making patient selection and biomarker identification crucial.
• Advances in technology, such as AI and blood-based diagnostics, are improving early patient identification and streamlining clinical trial processes.
• The potential of psychedelics for treating PTSD, depression, and anxiety is growing, but requires large-scale, robust trials due to a lack of biomarkers.
Neuroscience Investment Surges Amidst Hurdles in Clinical Research and Diagnosis
• Investment in neuroscience is increasing, driven by emerging treatments and the potential of psychedelics for conditions like PTSD and depression.
• A major challenge in neuroscience is the high cost and failure rate of Phase III trials, coupled with the poor translation of animal models to CNS disorders.
• Advances in technology, such as AI and blood-based biomarkers, are crucial for improving diagnostic efficiency and enabling targeted treatment approaches.
• Identifying the right patient population and improving diagnostic methods are key to tackling neurodegenerative diseases like Alzheimer's.
Compass Pathways Cuts 30% of Workforce Amid Phase 3 Trial Delays
• Compass Pathways is reducing its workforce by approximately 30% due to changing timelines for its Phase 3 trials of COMP360.
• The restructuring aims to focus the organization and its capital resources on the successful delivery of the COMP360 program.
• Non-COMP360 preclinical efforts will be discontinued, and the company is exploring externalization options for its digital health tools.
• The workforce reduction includes the elimination of some senior management positions within the company.
COMPASS Pathways Announces Delay in COMP360 Trial Data and Restructuring
• COMPASS Pathways delays COMP360 trial data release; COMP005 results expected Q2 2025, COMP006 in second half of 2026 due to recruitment challenges.
• The company is reducing its workforce by 30% and halting non-COMP360 preclinical efforts to preserve cash and focus on pivotal trials for treatment-resistant depression (TRD).
• COMPASS reaffirms commitment to COMP360, emphasizing its potential to address unmet needs in TRD, where many patients fail to achieve remission with existing therapies.
• Despite delays, COMPASS maintains a strong liquidity position and is optimizing commercial strategy, including collaborations with interventional psychiatry networks.
Madrigal's MASH Drug Rezdiffra Sees Strong Launch, Compass Pathways Lays Off Staff
• Madrigal Pharmaceuticals reported $62 million in third-quarter sales for Rezdiffra, its MASH treatment, exceeding expectations and tripling the number of patients on the drug.
• Compass Pathways is laying off 30% of its staff due to longer-than-expected clinical trial timelines for its psilocybin treatment COMP360 for treatment-resistant depression.
• A Phase 2 trial of UCB's tau-targeting antibody bepranemab in Alzheimer's disease slowed tau accumulation but failed to meet its primary endpoint of slowing disease progression.
Compass Pathways Delays Phase III Psilocybin Trial Readouts and Reduces Workforce
• Compass Pathways has delayed the Phase III trial readouts for its psilocybin-based therapy (COMP360) for treatment-resistant depression, pushing the data release for COMP005 to Q2 2025.
• The readout for the COMP006 trial, a two-dose study, has been postponed to the second half of 2026 due to increased regulatory scrutiny regarding functional unblinding.
• To focus resources on the COMP360 program, Compass Pathways will reduce its workforce by approximately 30%, affecting management and R&D positions.
• The decision was influenced by the FDA's concerns about functional unblinding, as seen in the rejection of Lykos Therapeutics' MDMA-assisted PTSD therapy.
Semaglutide Shows Promise for Osteoarthritis, Ozempic and Wegovy Availability Improves
• A recent study in the NEJM demonstrates that semaglutide significantly reduces knee pain and improves function in patients with severe obesity and knee osteoarthritis.
• The FDA indicates that Ozempic and Wegovy are now available across all doses, potentially ending the semaglutide shortage and impacting compounding pharmacies.
• Transcranial magnetic stimulation (TMS) shows potential in slowing Alzheimer’s disease progression, with a mid-stage trial reporting a 44% slower rate of disease progression.
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