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Compass Pathways Plc (Nasdaq: CMPS) is a biotechnology company at the forefront of mental health innovation, dedicated to accelerating patient access to evidence-based therapies. Headquartered in London, UK, with offices in New York and San Francisco, Compass is pioneering a new model of psilocybin therapy, specifically targeting treatment-resistant depression (TRD). The company’s flagship product, a proprietary high-purity polymorphic crystalline formulation of synthetic psilocybin known as COMP360, is at the core of their therapeutic approach.
Compass Pathways has made significant strides in mental health care by combining psilocybin treatment with psychological support. This dual approach is designed to provide comprehensive care for patients unresponsive to standard treatments. COMP360 has been designated a 'Breakthrough Therapy' by the U.S. Food and Drug Administration (FDA) and also received the Innovative Licensing and Access Pathway (ILAP) designation in the UK for TRD.
The company's research is supported by robust clinical trials. Compass has commenced a Phase 3 clinical program for COMP360, making it the largest randomized, controlled, double-blind psilocybin treatment clinical program ever conducted. Previous Phase 2b studies have shown that a single 25mg dose of COMP360 can significantly improve depressive symptoms with sustained effects over weeks. In addition to TRD, Compass is exploring the potential of COMP360 for treating post-traumatic stress disorder (PTSD) and anorexia nervosa through ongoing Phase 2 clinical trials.
Recent collaborations with leading healthcare institutions like Hackensack Meridian Health and Journey Clinical are aimed at understanding and optimizing the delivery models for COMP360, should it receive FDA approval. These partnerships also include exploration into therapist training and care reimbursement processes to ensure that the treatment can be integrated smoothly into existing healthcare systems.
Financially, Compass Pathways remains committed to transparency and regular updates to investors through various platforms including their website, social media, and investor relations channels. The company's vision is to create a world where mental well-being is within reach for all.
For the latest news and updates on Compass Pathways, visit www.compasspathways.com.
COMPASS Pathways (Nasdaq: CMPS) announced funding for the first study exploring the effects of COMP360 psilocybin on brain pathways in autistic adults. The double-blind, randomized, placebo-controlled study, named PSILAUT, will assess serotonin brain network differences between autistic and non-autistic individuals. Conducted at King's College London, it will involve 70 participants, including 40 with autism. Professor Grainne McAlonan leads the research, aiming to enhance treatment options for autism by understanding underlying brain mechanisms.
COMPASS Pathways plc (Nasdaq: CMPS) announced it will release its financial results for Q1 2022 and provide a business update on May 10, 2022. The management will host a conference call at 8:00 AM ET. The call will also be accessible via webcast and archived for 30 days. COMPASS is focused on mental health innovations using its synthetic psilocybin formulation, COMP360, which has received FDA Breakthrough Therapy designation for treatment-resistant depression. The company recently completed a Phase IIb clinical trial, showing statistically significant improvements in depressive symptoms.
COMPASS Pathways (Nasdaq: CMPS) presented positive data on COMP360 psilocybin therapy in two investigator-initiated studies at the Society of Biological Psychiatry Annual Meeting in New Orleans. The first study involved 12 patients with severe treatment-resistant depression, reporting a 58.3% response rate and no serious adverse events. The second study with 10 anorexia nervosa patients showed 30% achieving significant reductions in symptoms at one-month follow-up. Both studies demonstrated the therapy's potential, supporting further investigation in larger clinical trials.
COMPASS Pathways reported positive results from its phase IIb COMP360 psilocybin therapy trial for treatment-resistant depression, showing rapid and sustained patient response with a single 25mg dose. Additionally, an open-label study indicated effectiveness when combined with SSRI antidepressants. The company is well-capitalized with a cash position of $273.2 million at year-end 2021. The end-of-phase II meeting with the FDA is scheduled for April 2022, with a phase III program expected to start in the second half of the year. New senior executives have also been appointed.
COMPASS Pathways (Nasdaq: CMPS), a mental health care company, is set to release its financial results for Q4 and the entire year of 2021, along with an update on recent developments, on February 24, 2022. A conference call will follow at 8:00 AM ET, accessible via phone and webcast. COMPASS is pioneering a new model of psilocybin therapy, recently achieving significant results in a large-scale clinical trial for treatment-resistant depression.
COMP360, its breakthrough therapy, is currently in further clinical trials for PTSD.
COMPASS Pathways plc (CMPS) has announced positive results from a phase I study on COMP360 psilocybin therapy, demonstrating its feasibility in simultaneous administration to healthy participants under 1:1 therapist support. Conducted by King's College London, the study involved 89 participants receiving different doses of psilocybin or placebo, with no serious adverse effects reported. The findings suggest potential for psilocybin therapy in treating severe mental health issues, paving the way for upcoming FDA discussions and plans for a phase III trial expected to begin in Q3 2022.
COMPASS Pathways (Nasdaq: CMPS) announced its addition to the Nasdaq Biotechnology Index, effective December 20, 2021. This index tracks biotech and pharmaceutical securities, making it significant for institutional investors. CEO George Goldsmith expressed pride in this achievement, which aims to enhance visibility as the company advances its COMP360 psilocybin therapy for mental health. This therapy has received FDA Breakthrough Therapy designation for treatment-resistant depression and has shown statistically significant clinical trial results.
COMPASS Pathways (Nasdaq: CMPS) has appointed Matthew Owens as its new General Counsel and Chief Legal Officer, effective February 1, 2022. Owens joins from Novartis, where he was the Global Head of Legal, Digital. Concurrently, Lars Wilde, co-founder and Chief Business Officer, will transition to a senior advisory role from January 1, 2022. Under Wilde's leadership, COMPASS raised over $429 million and advanced its psilocybin therapy for mental health, which has received Breakthrough Therapy designation from the FDA.
COMPASS Pathways (Nasdaq: CMPS) announced positive results from its study of COMP360 psilocybin therapy in patients concurrently taking SSRIs. In this phase IIb trial, 19 patients treated with a 25mg dose had comparable outcomes to those who discontinued SSRIs before treatment. 42.1% of participants responded after three weeks, with an average MADRS score reduction of 14.9. Notably, no serious adverse events emerged. COMPASS is now preparing to meet with the FDA to finalize its phase III program planned to start in Q3 2022.
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