COMPASS Pathways

A comprehensive pipeline report reveals over 75 companies are developing innovative treatments for major depressive disorder, with several promising candidates advancing through Phase III trials.

Compass Pathways achieved its primary endpoint in a Phase 3 trial of psilocybin for treatment-resistant depression, showing a 3.6-point greater reduction in MADRS scores compared to placebo.

• 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.

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.

• 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 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.

Compass Pathways' synthetic psilocybin drug COMP360 achieved its primary endpoint in a Phase 3 trial for treatment-resistant depression, showing a 3.6-point greater symptom reduction versus placebo.

• 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, 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 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.