Small Pharma Expands Potential of Commercial Portfolio With DMT-Based Psychedelic Assets

Lead DMT-assisted therapy candidate SPL026’s clinical development program strengthened with the addition of two clinical trials planned for 2022

SPL028, a deuterated DMT candidate with Composition of Matter patent protection in the UK, moves towards Phase I clinical trial in H2 2022 on positive preclinical data

LONDON, March 10, 2022 (GLOBE NEWSWIRE) -- Small Pharma Inc. (TSXV: DMT) (OTCQB: DMTTF) (the “Company” or “Small Pharma”), a neuroscience company focused on psychedelic-assisted therapies for mental health conditions, announces research and development updates on two N,N-dimethyltryptamine (“DMT”) based candidates, SPL028 and SPL026. Small Pharma’s pipeline of short duration psychedelics have the potential to offer effective, accessible and practical in-clinic treatments with patients and clinicians in mind for a range of mental health conditions. Two additional trials have been added to SPL026’s development program while the SPL028 program moves towards a Phase I clinical trial in H2 2022.

SPL026 Update

Following the success of its lead DMT candidate SPL026’s Phase I trial, Small Pharma is expanding its development program with the addition of a drug interaction study, planned for 2022. This study will assess the impact of antidepressants on the safety, tolerability, pharmacokinetics and pharmacodynamics of SPL026 with psychotherapy. These endpoints will be assessed in patients with Major Depressive Disorder (“MDD”), who are currently on a course of selective serotonin reuptake inhibitors (“SSRIs”) but have not achieved satisfactory results, compared with those not taking an SSRI. A better understanding of how DMT-assisted therapy interacts with existing antidepressants opens up the potential to reach the broadest population of patients suffering from MDD.

Small Pharma is also planning a further Phase I study of SPL026 with healthy volunteers in 2022 to compare the treatment profile of intramuscular (“IM”) versus intravenous (“IV”) modes of administration. IM injection would offer a simple injectable form that could further enhance convenience and accessibility for patients and clinicians.

Dr. Carol Routledge, Chief Medical and Scientific Officer of Small Pharma said: “We want to maximize access to DMT therapy for the greatest number of patients. We recognize that for some MDD patients, coming off antidepressants can be a difficult process. Additionally, we are looking to explore optimized treatment routes. By continuing our research in these new avenues, our ambition is to identify the best potential treatment options for patients with major depression.”