Mindset Pharma Inc. announced that it has received approval from the U.K. Medicines and Healthcare products Regulatory Authority (the "MHRA") and the Research Ethics Committee to initiate a Phase II study of MSP-1014, its novel psilocin prodrug, evaluating its safety and efficacy in treating patients suffering from major depressive disorder (MDD). The Phase II study will be conducted in two parts. In Part 1, Mindset will assess the safety and tolerability of up to three escalating doses of MSP-1014.

In conjunction with MSP-1014, study participants will receive Acceptance and Commitment Therapy (ACT). In Part 2, a randomized and placebo-controlled study, Mind set will assess the safety and efficacy of a single dose of MSP-1014), selected from Part 1. An equal number of patients will receive MSP-1014 or placebo (non-active) control and all will receive 6 sessions of ACT. 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. MSP-1014, which sits outside of Mindset's collaboration with the McQuade Center for Strategic Research and Development, is derived from Mindset's "Family 1" of novel drugs, which enjoys robust composition of matter intellectual property protection in multiple jurisdictions. The Phase II clinical trial may commence as early as fourth quarter 2023.