Small Pharma Inc. (TSXV: DMT | OTCQB: DMTTF), a biotechnology company focused on short-acting psychedelic-assisted therapies for mental health conditions, today confirms that the first patient has been dosed in the Company’s Phase Ib drug interaction study. The study aims to assess the interaction between selective serotonin reuptake inhibitors and SPL026, the Company’s lead N, N-dimethyltryptamine (“DMT”) candidate, in patients with Major Depressive Disorder (“MDD”).
The open-label study is being conducted at two MAC Clinical Research sites in the United Kingdom and will investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, and exploratory efficacy of SPL026, alone or in combination with SSRIs, in up to 24 patients. The trial will assess a single dose of SPL026 in patients currently on a treatment course of SSRIs that have been ineffective in fully relieving their depression, compared to patients who are not currently using any pharmacological treatment to treat their depression. All patients will receive SPL026 with supportive therapy.
“With the SSRI drug interaction study now fully underway, we look forward to the results which, if encouraging, have the potential to facilitate patient recruitment in additional Company trials by removing the requirement for patients to be withdrawn from their existing SSRI medication. In the longer term, successful results could expand patient access to SPL026 therapy.”
Dr. Carol Routledge, Chief Medical and Scientific Officer
George Tziras, Chief Executive Officer, added: “We are approaching the end of 2022 with plenty of momentum as we prepare to initiate two additional clinical trials. We also expect to complete patient follow-ups in our lead SPL026 Phase IIa study by the end of the year, with results due soon afterwards.”
About Small Pharma
Small Pharma is a biotechnology company progressing a pipeline of short-acting psychedelic-assisted therapies for the treatment of mental health conditions. The Company’s current focus is on exploring new therapeutic approaches for depression. Small Pharma’s lead candidate, SPL026, is a proprietary synthetic formulation of DMT. The Company is advancing a clinical program of intravenous SPL026 with supportive therapy for the treatment of MDD, which was granted an Innovation Passport designation from the U.K. Medicines and Healthcare products Regulatory Agency. In addition, Small Pharma has a pipeline of proprietary preclinical assets in development.