Small Pharma Inc (TSX-V:DMT, OTCQB:DMTTF) has announced research and development updates on two N,N-dimethyltryptamine (DMT) based candidates, SPL028 and SPL026.
The company'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.
READ: Small Pharma shares analysis of Phase I data from the combined Phase I/IIa clinical trial of SPL026 with psychotherapy
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.
In a statement, Dr Carol Routledge, chief medical and scientific officer of Small Pharma commented: "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.”
SPL028 through preclinical studies
Small Pharma has also advanced its proprietary deuterated DMT candidate SPL028 through preclinical studies. The goal is to deliver a treatment with an extended psychedelic experience, as compared to SPL026, but still significantly shorter than the experience of other psychedelics, such as psilocybin and LSD.
Through SPL028, Small Pharma is exploring whether an extended duration could offer a DMT treatment tailored for other mental health conditions. Additionally, the pharmacokinetic profile of SPL028 offers the opportunity for optimizing alternative routes of administration beyond IV.
The final candidate of SPL028 was selected after screening a range of deuterated DMT compounds through in vitro and in vivo studies. Importantly, preclinical studies suggest that SPL028 offers a similar safety and pharmacological profile to SPL026, while being differentiated by its pharmacokinetics, to offer a potentially extended psychedelic experience as compared to SPL026.
Dr Routledge noted: "The rapid effects of DMT, as highlighted in recent Phase I data, offers the flexibility to engineer alternative DMT candidates that could deliver extended yet convenient and accessible in-clinic treatment options for a broader range of mental health conditions. SPL028’s promising preclinical data demonstrates its similarities to DMT from a safety and behavioural perspective, allowing for a potentially expedited route to the clinic.”
In H2 2022, Small Pharma- said it intends to initiate a Phase I study of SPL028 with psychotherapy among healthy volunteers to assess safety, tolerability, pharmacodynamics and pharmacokinetics of IM and IV administration. This study will allow Small Pharma to better understand the profile of SPL028 as a therapeutic candidate and identify the optimal route of administration in a clinical setting.
Small Pharma is a neuroscience company specialized in discovering and developing novel treatments for mental health conditions, with a current focus on depression.
The company initiated a clinical program into DMT-assisted therapy in February 2021. This program includes a Phase I/IIa trial on the Company’s lead candidate alongside development of a robust pipeline of proprietary preclinical assets.
DMT is a naturally occurring psychedelic tryptamine found in plants and in the brain of mammals. Scientific evidence suggests DMT offers the potential for rapid-acting and long-lasting antidepressant effects. DMT is differentiated by its short psychedelic experience (less than 30 mins), which allows for short treatment sessions and offers the potential for convenient supervised treatments within patient clinics.
Small Pharma is advancing a pipeline of DMT-based therapies and is leading the world’s first DMT clinical trial for depression, in collaboration with Imperial College London.
Contact the author at jon.hopkins@proactiveinvestors.com