Small Pharma Inc. announced that it has received approval from the U.K. Medicines and Healthcare products Regulatory Authority (the “MHRA”) and the Regional Ethics Committee to initiate a drug interaction clinical trial in the U.K. The study will assess the interaction between serotonin reuptake inhibitors (“SSRIs”) and SPL026, the Company's lead N, N-dimethyltryptamine (“DMT”) candidate, in patients with Major Depressive Disorder (“MDD”). This study is being conducted at two MAC Clinical Research sites and will assess the impact of SSRIs on the safety, tolerability, pharmacokinetics and pharmacodynamics of SPL026 with psychotherapy in up to 24 patients. These endpoints will be assessed in patients with MDD who are currently on a treatment course of a SSRI that is ineffective in fully relieving their depression, compared with patients not currently on a prescribed SSRI.

The trial is expected to begin in Third Quarter 2022, with dosing completion anticipated in H1 2023.