Small Pharma Inc. (TSXV: DMT | OTCQB: DMTTF), a biotechnology company focused on short-acting psychedelic-assisted therapies for mental health conditions, today announces that it has received approval from the U.K. Medicines and Healthcare products Regulatory Authority 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 candidate, in patients with Major Depressive Disorder.
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 Q3 2022, with dosing completion anticipated in H1 2023.
“In the Phase I/IIa SPL026 clinical trial currently underway, patients must be withdrawn from existing antidepressant medication, which can be disruptive and unsettling for some. This may not always be in the best interest of patients, even if the medication is ineffective. Encouraging results from this study could facilitate patient recruitment in future clinical trials as patients may no longer be required to discontinue their SSRI medication. In the longer term, successful results could open up the potential to broaden patient accessibility to DMT-assisted psychotherapy.
Dr. Carol Routledge, Chief Medical and Scientific Officer
George Tziras, Chief Executive Officer, added: “Patient access is a core element of Small Pharma’s values and strategy, which is reflected in our approach to research and development. As we progress through our clinical programs, it’s key that we are agile and most importantly patient-led.”
About Small Pharma
Small Pharma is a biotechnology company progressing a pipeline of short-acting psychedelics with therapy for the treatment of mental health conditions, with a current focus on depression. Small Pharma initiated a clinical program into DMT assisted psychotherapy in February 2021. This program includes a Phase I/IIa trial on the Company’s lead candidate alongside the development of a pipeline of proprietary preclinical assets.
About DMT
DMT is a naturally occurring psychedelic tryptamine found in plants and in the brain of mammals. Scientific evidence suggests DMT offers the potential for rapid-acting and long-lasting antidepressant effects. DMT is differentiated by its short psychedelic experience (< 30 mins), which allows for short treatment sessions and offers the potential for convenient supervised treatments within patient clinics.