Small Pharma Inc. (OTCQB:DMTTF), a biotech company that develops short-acting psychedelic-assisted therapies for depression, received approval from the U.K. Medicines and Healthcare products Regulatory Authority (MHRA) and the Research Ethics Committee to begin a Phase 1 clinical study of its deuterated form of DMT, SPL028.
“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,” CEO George Tziras stated.
The randomized, placebo-controlled, blinded, dose-escalating study will be conducted at MAC Clinical Research in Manchester, England starting in the first half of 2023.
The trial is designed to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of intramuscular (IM) and intravenous (IV) administration of SPL028, to be paired with psychotherapy in healthy volunteers.
Small Pharma’s chief medical and scientific officer Dr. Carol Routledge explained that the first-in-human study of the company’s proprietary drug constitutes a milestone in what could potentially become a treatment option with a more extended psychedelic experience as compared to another lead candidate, SPL026’s, which is approx. 20 minutes.
Dr. Routledge affirmed that the new SPL028 maintains Small Pharma’s goal of providing significantly shorter experiences than that of psilocybin or LSD, which are between six and twelve hours each.
“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,” she concluded.
Small Pharma’s CEO added that SPL028 has multi-layered IP protection in several jurisdictions for composition of matter, synthesis and injectable 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,” he specified.
Indeed, the company’s current focus is to explore new therapeutic approaches for depression. Small Pharma’s lead candidate SPL026, a proprietary synthetic formulation of DMT, is currently advancing a clinical intravenous (IV) program backed with psychotherapy for the treatment of Major Depressive Disorder (MDD), which was granted an Innovation Passport designation by the MHRA.
The novel SPL028 program provides a potential 30-minute psychedelic experience which would optimize patient convenience while expanding the therapeutic aid in cases of depressive disorders and other indications as well.
Photo by Talha Hassan on Unsplash
