Biotechnology company, Small Pharma Inc. (TSXV: DMT) (OTCQB: DMTTF) has achieved an “exciting milestone” in its mission to progress drugs derived from dimethyltryptamine.
On Monday, the company announced that it had been granted approval from the Research Ethics Committee and U.K. Medicines and Healthcare products Regulatory Authority to begin a phase I trial with healthy participants examining the effects of SPL028, a patented injectable DMT drug.
Through the new study, the company will be investigating a short psychedelic experience lasting less than 30 minutes which is intended to offer convenience to patients. Psilocybin and LSD experiences for example can last anywhere between six and 12 hours.
📣 Small Pharma has received approval from the MHRA and Research Ethics Committee to enter a Phase I first-in-human clinical trial with our proprietary deuterated candidate, SPL028. Full press release: https://t.co/51nT8PzaVn #mentalhealth #clinicaltrials #psychedelics pic.twitter.com/jqNcavaz9w
— Small Pharma (@SmallPharma) October 31, 2022
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The phase I study of SPL028 will be a so-called blinded, dose-escalating study taking place at MAC Clinical Research in Manchester, England. The trial will be designed to assess the safety, tolerability, pharmacodynamics and pharmacokinetics of intravenous and intramuscular administration of SPL028.
The company expects to gain an improved understanding of the drug and its therapeutic potential through the trial, which is expected to commence before the end of June next year.
“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 12 hours,” said Dr. Carol Routledge, chief scientific and medical officer of the company.
“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.”