Pharma Focus Europe

Small Pharma Receives Approval for First-In-Human Phase I Clinical Trial With SPL028

Tuesday, November 01, 2022

Small Pharma Inc., 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 (the “MHRA”) and the Research Ethics Committee to initiate a Phase I study of SPL028, its proprietary deuterated N, N-dimethyltryptamine (“DMT”) candidate, with supportive therapy in healthy volunteers. Through the SPL028 program, Small Pharma is exploring a >30-minute short psychedelic experience aimed at optimizing patient convenience and expanding the therapeutic potential in depressive disorders and additional indications.

This SPL028 Phase I study is planned to be a randomized, placebo-controlled, blinded, dose-escalating study to be conducted at MAC Clinical Research in Manchester, England. It is designed to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of intramuscular (“IM”) and intravenous (“IV”) administration of SPL028, which is expected to allow Small Pharma to better understand the profile of SPL028 as a therapeutic candidate. The study is anticipated to initiate in H1 2023.

Dr. Carol Routledge, Chief Medical and Scientific Officer, said: “This is an exciting milestone as we prepare to enter our first-in-human clinical trial with our proprietary deuterated candidate, SPL028. The goal is to deliver a treatment with a more extended psychedelic experience compared to our lead candidate, SPL026, which is around 20 minutes, but still significantly shorter than the psychedelic experiences of psilocybin or LSD, which are between six and twelve hours. We anticipate that the results of this Phase I study will help us make a data-driven decision in selecting the dose and route of administration to take forward into potential future studies in patients.”

George Tziras, Chief Executive Officer, added: “Progressing our second candidate towards the clinic marks a significant step for Small Pharma. Our focus continues to be in evaluating short-acting psychedelic therapies due to their potential as scalable treatments, which we see as critical given the magnitude of the mental health crisis. We look forward to understanding more about the profile of SPL028 and its potential in addressing areas of unmet patient need within mental health. SPL028 has multi-layered intellectual property protection in multiple jurisdictions providing protection for Composition of Matter, synthesis, and injectable pharmaceutical formulations. The protection currently consists of four granted patents across the U.S., Canada, the U.K. and Europe and over 30 pending patent applications.”

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