Commercial trial to treat major depressive disorder with psychedelic drugs given green light by MHRA

The Medicines and Healthcare products Regulatory Authority has now provided regulatory approval to see whether a novel psilocin prodrug can treat major depressive disorder when combined with therapy. The trial has been designed by Clerkenwell Health – a fast-growing British start-up that designs and delivers clinical trials to find cutting-edge treatments for complex mental health conditions. Delivered in their London facility, the treatment will enable patients to stay on their antidepressants for the duration of the trial.

The trials will combine dosages of the psilocin-based drug with specialist therapy, delivered by therapists who have undertaken Clerkenwell’s first-of-its-kind training programme for programme for therapists delivering therapy in conjunction with psychedelic drugs.

The trials come at a time when innovative ways to treat depression are sorely needed. Statistics show that one in four people taking antidepressants in the UK have done so for more than five years, and recent studies have estimated the cost of mental health problems to the UK economy at over £110bn a year.

Tom McDonald, CEO at Clerkenwell Health, said: “We’re incredibly excited to be given the green light for this trial to explore an innovative treatment to a mental health condition which blights millions of people’s lives in the UK. “Our work with Mindset is part of a suite of trials we’re planning to undertake in the next 12 months, to test the potential of psychedelics-related medicines for complex mental health and central nervous system conditions including alcohol use disorder and PTSD."

Joseph Araujo, Chief Scientific Officer of Mindset, remarked: "This is an exciting milestone as we prepare to enter our first-in-human clinical trial with our novel psilocin prodrug, MSP-1014. Based on pre-clinical data, we believe that MSP-1014 has the potential to be a better tolerated psychedelic therapeutic compared to psilocybin. This approval for a Phase II study should provide us with a strong efficacy signal and expedite our pathway to approval for MSP-1014 as a new effective and more tolerable treatment for patients suffering from MDD."

The drug being used in the trial, titled MSP-1014, has been designed by Mindset Pharma Inc – a drug discovery and development company focused on creating optimized and patentable best-in-class innovative next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet needs.

MSP-1014 is anticipated to exert similar efficacy to psilocybin in improving symptoms of depression. Preclinical studies comparing MSP-1014 to psilocybin suggest that the tolerability of MSP-1014 may be superior to psilocybin.