Mindset Pharma Inc (CSE:MSET, OTCQB:MSSTF) has received approval from the UK Medicines and Healthcare products Regulatory Authority and the Research Ethics Committee to begin a Phase 2 study of its novel psilocin prodrug.
The study will evaluate MSP-1014’s safety and efficacy in treating patients suffering from major depressive disorder.
Part one of the study will assess the safety and tolerability of up to three escalating doses of MSP-1014. Part two will assess the safety and efficacy of a single dose of MSP-1014, selected from Part 1.
Patients will receive acceptance and commitment therapy in conjunction with MSP-1014. In part two, an equal number of patients will receive MSP-1014 or a placebo control.
MSP-1014 is a novel and patent-protected prodrug of psilocin, the active metabolite of psilocybin.
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.
"This is an exciting milestone as we prepare to enter our first-in-human clinical trial with our novel psilocin prodrug, MSP-1014,” said Joseph Araujo, Mindset’s chief scientific officer.
“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."
Contact Andrew Kessel at andrew.kessel@proactiveinvestors.com
Follow him on Twitter @andrew_kessel