UK Psychedelics: Phase 3 Depression & Alcohol Addiction Trials, New London Center

The U.K. Medicines and Healthcare Regulatory Agency (MHRA) has green-lighted two separate Phase 3 trials conducted by Compass Pathways CMPS for Treatment-Resistant Depression and Awakn Life Sciences AWKNF for Severe Alcohol Use Disorder (SAUD).

Details On Trials

Compass Pathways plc CMPS will initiate the UK arm of its Phase 3 program on psilocybin therapy COMP360 for Treatment-Resistant Depression (TRD).

The ongoing program is reportedly the largest randomized, controlled, double-blind psilocybin treatment clinical program ever conducted. It consists of two pivotal trials, COMP 005 and COMP 006, each with an integrated long-term outcomes component.

Following the MHRA approval of the study, the multiple UK sites to participate in part of the company’s pivotal Phase 3 program include Compass’ newly-opened Centre for Mental Health Research and Innovation in London, where COMP 006 (assessing 25mg, 10mg and 1mg of COMP360) will take place.

Developed in partnership with South London and Maudsley NHS Foundation Trust and the Institute of Psychiatry, Psychology & Neuroscience at King’s College London, the new R&I center is located at the Maudsley Hospital in South London and will be run by Prof. Allan Young and Dr. James Rucker, respectively KCL’s Head of Academic Psychiatry and KCL’s Lead of the Psychoactive Trials Group. 

Aiming to accelerate psychedelic research and develop care models for mental health in the UK, research will initially focus on areas of urgent need, including TRD and anorexia nervosa. Integration of these investigational treatments into health systems, if approved, will include evaluating real-world evidence, researching and developing digital technologies to help deliver personalized, predictive and preventative care models as well as conducting therapist training.

Compass CEO Kabir Nath says the launch of the Phase 3 TRD clinical study in the UK is “an important step in developing innovations that are urgently needed,” in which public-private partnerships, he says, play an important role.

Awakn's Regulatory And Ethical Approval For Phase 3 Ketamine Trial For SAUD

Specialized addiction therapeutics company Awakn Life Sciences Corp. AWKNF has also received clinical trial authorization from the MHRA and ethical approval from the Health Research Authority in the UK for a Phase 3 clinical trial on lead program AWKN-P001 for the treatment of Severe Alcohol Use Disorder (SAUD.)

With patient enrollment (n=280) starting in Q1 2024, AWKN-P001 is a novel treatment combining NMDA receptor-modulating drug ketamine with psycho-social support targeting the most acute type of alcohol use disorder. Prior Phase 2 study results were sound positive, achieving 86% abstinence six months post-treatment, vs. 2% abstinence pre-trial and 25% abstinence in current standard of care.

The trial is being funded by Awakn, the University of Exeter and a partnership between the National Institute for Health and Care Research (NIHR) and the Medical Research Council (MRC).

CEO Anthony Tennyson called the regulatory and ethical approval “a testament” to Awakn’s commitment to scientific rigor and patient well-being, as well as “a pivotal step” in the company’s commercial journey, opening “new horizons” as it moves one step closer to delivering a potentially transformative therapy to the market. 

“Our Phase 3 clinical trial represents a crucial bridge between cutting-edge science and a commercially viable solution for addressing severe alcohol use disorder," Tennyson concluded.

Photo: Benzinga edit with photo by Dana Creative Studio, PanuShot and Arif_Vector on Shutterstock.