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 its Phase I study comparing the profiles of intramuscular (“IM”) and intravenous (“IV”) , the Company’s proprietary formulation of N, N-dimethyltryptamine (“DMT”).
The goal of the study, which is being conducted at Hammersmith Medicines Research Ltd. in the United Kingdom, is to compare the safety, tolerability, pharmacokinetics and pharmacodynamics of SPL026 delivered via IM versus IV administration, in up to 14 healthy volunteers.
“IM injection of SPL026 may provide greater convenience for physicians, as well as potentially improve the treatment experience for some patients. This study seeks to identify a target dose of SPL026, administered via IM injection, that is well tolerated and delivers a consistent breakthrough psychedelic experience. By understanding parameters such as the duration and intensity of the psychedelic experience, we will be able to explore the potential application of IM SPL026 for treating mental health conditions.”
Dr. Carol Routledge, Chief Medical and Scientific Officer
George Tziras, Chief Executive Officer, added: “Patient access is core to our mission. It is reflected in our decision to focus on short-duration psychedelics delivered through different administration routes, with the goal of maximizing patient reach and convenience. With the Phase IIa study of IV SPL026 in Major Depressive Disorder now completed, and results anticipated very soon, we are a step closer to understanding the potential efficacy of SPL026 as a depression treatment. These proof-of-concept results, combined with the results of our other SPL026 studies, will help guide our future clinical development and commercialization strategy.”
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 clinical programs of SPL026 with supportive therapy for the treatment of mental health conditions and was granted an Innovation Passport designation from the U.K. Medicines and Healthcare products Regulatory Agency (the “MHRA”) for intravenous SPL026 with supportive therapy for Major Depressive Disorder. In addition, Small Pharma has a pipeline of proprietary preclinical assets in development.