CMPS - One Year Into Kabir Nath’s Leadership Compass Pathways’ (NASDAQ: CMPS) Phase 3 Trial For Innovative Treatment Resistant Depression Progressing
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By Faith Ashmore, Benzinga
Treatment-resistantdepression, also referred to as TRD, is a subset of depression thatposes significant challenges for clinicians, patients and thoseclosest to patients. It is characterized by persistent symptoms ofdepression that do not respond adequately to at least two differentstandard antidepressant treatments. This debilitating condition oftenleaves individuals grappling with feelings of despair, hopelessnessand a diminished quality of life.
Unlike some forms of depression that may improvewith pharmacological interventions or talk therapies, TRD tends topersist, leading to a multitude of negative consequences. Theunyielding nature of this condition can contribute to increased ratesof disability, higher suicide risk and significant financial burdendue to the need for repeated treatments. Psilocybin treatment isemerging as a potentially effective approach to the treatment ofTRD.
Althoughfurther research is still needed to establish its efficacy and safety,initial findings are promising. While there are a number of companiesdeveloping psilocybin treatments, Compass Pathways (NASDAQ:CMPS) is setting itself apart from its contemporaries with its phase 3program in TRD.
The company’s innovative approach has received FDABreakthrough Therapy designation in the U.S. and Innovative Licensingand Access Pathway designation in the U.K. for their investigationalCOMP360 psilocybin. Moreover, in late 2021, Compass Pathways announcedthe completion of a randomized, controlled double-blind phase 2b studyof COMP360 psilocybin treatment involving 233 patients with TRD in 22sites across Europe and North America.
In August of 2022, Compass Pathways brought onKabir Nath as CEO to help navigate its transition from a start-up toan established phase 3 biopharma company. Nath is a seasonedhealthcare executive with over two decades of experience leadingglobal pharmaceutical companies. He has held several leadershippositions at multinational corporations, including Bristol MeyersSquibb (NYSE: BMS), GlaxoSmithKline (NYSE: GSK) and Otsuka Pharmaceutical (OTCMKTS: OTSKY).
Nath has a track recordof success in developing new products and creating commercialstrategies to make medicines available to patients on a global scale.He is skilled in identifying unmet patient needs and workingcollaboratively with stakeholders to develop targeted and effectivetreatment options. He also has considerable experience in psychiatricdrug development.
Under Nath’s leadership, Compass Pathways has madesignificant progress in advancing the development of itsinvestigational drug, COMP360 psilocybin. One notable accomplishmentwas the initiation of their phase 3 clinical trials, which are pivotalin determining the safety and efficacy of the treatment. These trialsconsist of two key studies: Pivotal Trial 1 (COMP005) and PivotalTrial 2 (COMP006).
COMP005 is studying a single dose (25mg) of COMP360 psilocybinas monotherapy, comparing it with a placebo. The aim of this trial isto replicate the positive treatment response observed in thecompany’s phase 2b study, which included 233 patients withtreatment-resistant depression.
COMP006 is a fixed repeat dose monotherapy studythat examines the effects of three different dose arms: 25mg, 10mg and1mg. The objective of this trial is to investigate whether a seconddose can enhance the number of responders and further improve theresponse observed in the phase 2b study. Additionally, this trialexplores the potential for a meaningful treatment response from therepeat administration of COMP360 10mg.
Both pivotal trials have the change frombaseline in MADRS (Montgomery-Åsberg Depression Rating Scale) totalscore at week six as their primary endpoint. This measure allowsresearchers to evaluate the effectiveness of COMP360 psilocybin inreducing depressive symptoms compared to baseline.
In addition to drivingthe company forward into phase 3, Nath has supported the developmentof the company’s digital platforms that accompany its psilocybintreatment, has led a successful private placement fundraising thatextends the company’s runway into late 2025, and claims to have oneof the most talented and experienced leadership team among psychedeliccompanies in the space. Nath's global experience in thepharmaceutical industry and his expertise in developing andcommercializing treatments for unmet needs uniquely position him tolead Compass Pathways toward the successful development andcommercialization of their investigational drug COMP360 psilocybin,subject to FDA approval.
Company BioCOMPASS Pathways plc(Nasdaq: CMPS) is a mental health care company dedicated toaccelerating patient access to evidence-based innovation in mentalhealth. Our focus is on improving the lives of those who are sufferingwith mental health challenges and who are not helped by currenttreatments. We are pioneering the development of a new model ofpsilocybin therapy, in which our proprietary formulation of syntheticpsilocybin, COMP360, is administered in conjunction with psychologicalsupport. COMP360 has been designated a Breakthrough Therapy by theU.S. Food and Drug Administration (FDA) and has received InnovativeLicensing and Access Pathway (ILAP) designation in the UK fortreatment-resistant depression (TRD). We have commenced a phase 3clinical program of COMP 360 psilocybin therapy in TRD, the largestrandomised, controlled, double-blind psilocybin therapy clinicalprogram ever conducted. Previously, we completed a phase 2b study withtop line data showing a statistically significant (p<0.001) andclinically relevant improvement in depressive symptom severity afterthree weeks for patients who received a single high dose of COMP360psilocybin with psychological support. We are also conducting phase 2clinical studies of COMP360 psilocybin therapy for post-traumaticstress disorder (PTSD) and anorexia nervosa. COMPASS is headquarteredin London, UK, with offices in New York and San Francisco in theUnited States. Our vision is a world of mental wellbeing.
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Contact Details
StephenSchultz
stephen.schultz@compasspathways.com
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