Summary: The UK’s MHRA has approved a first-of-its-kind trial to test a novel psilocin-based drug, MSP-1014, for major depressive disorder. The trial, developed by Mindset Pharma, will combine dosages of the new drug with specialist therapy.
UK Greenlights Trial for Psilocin-Based Drug in Major Depressive Disorder Treatment
The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has approved a first-of-its-kind trial to test a novel psilocin-based drug for major depressive disorder (MDD). The clinical trial, set to run this year, will combine dosages of a new psilocin-based drug, MSP-1014, with specialist therapy.
MSP-1014, developed by Mindset Pharma, is a novel psilocin prodrug anticipated to exert similar efficacy to psilocybin in improving symptoms of depression. “This is an exciting milestone as we prepare to enter our first-in-human clinical trial with our novel psilocin prodrug… [which based on preclinical data] has the potential to be a better tolerated psychedelic therapeutic compared to psilocybin,” stated Joseph Araujo, Chief Scientific Officer of Mindset Pharma.
The MHRA’s regulatory decision follows an agreement in December 2022 by Mindset Pharma and several other psychedelic drug developers to trial therapies for mental health conditions in London. This location was chosen to benefit from the UK’s drug regulatory process, which allows for fast-tracked ethics applications and combined reviews.
Tom McDonald, CEO at Clerkenwell Health, expressed excitement about the green light for the trial, which will explore an innovative treatment for a mental health condition such as MDD. Clerkenwell Health plans several other trials for the next year to “test the potential of psychedelics-related medicines for complex mental health and central nervous system conditions including alcohol use disorder and PTSD,” added McDonald.
[Source: European Pharmaceutical Review]Subscribe to our newsletter
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