Psychedelic biotechnology company Small Pharma Inc. (TSXV: DMT) (OTCQB: DMTTF) announced today confirmation of regulatory 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. to assess the interaction between serotonin reuptake inhibitors also known as SSRIs and the Company’s lead N, N-dimethyltryptamine DMT candidate SPL026 for patients with Major Depressive Disorder (MDD).
Study will explore the interaction between SSRI antidepressants and DMT-based SPL026, potentially broadening patient reach to those currently taking a SSRI.
The company who currently are focused on short-acting psychedelic-assisted therapies for mental health conditions will conduct the study 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.
The 6-week assessment will compare endpoints for patients currently on an ineffective SSRI treatment course with those who are not. Patients who are already on a SSRI that is ineffective in fully alleviating their depression will be compared to those who are not presently on a prescribed SSRI. The study is expected to begin in Q3 2022, with dosage completion anticipated by H1 2023.
Chief Medical and Scientific Officer for Small Pharma Dr. Carol Routledge believes 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.
Small Pharma CEO George Tziras added to the sentiment stating that patient access is a core element of Small Pharma’s values and strategy, which is reflected in the approach to research and development.
About Small Pharma
Small Pharma is a small biotech firm with a research and development pipeline of short-acting psychedelics for the treatment of mental health disorders, with depression as its main focus. In February 2021, Small Pharma began a clinical study involving DMT aided psychotherapy. This study will combine the Company’s lead drug candidate with the creation of a proprietary preclinical asset development pipeline.
DMT (1,5-dimethoxy-4-(n)-propylthio)phenethylamine is a naturally occurring psychedelic tryptamine found in plants and the brains of mammals. DMT has been shown to have rapid-acting and long-lasting antidepressant effects based on scientific evidence.
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.