Appointment of MAC Clinical Research to accelerate timeline of Phase I/IIa clinical trial of SPL026 for Major Depressive Disorder

Quick Take

Small Pharma Inc. (TSXV: DMT), a neuropharmaceutical company focused on psychedelic-assisted therapies, today announces the expansion of its Phase I/IIa clinical trial for its lead product, SPL026, a N,N-dimethyltryptamine (“DMT”) based treatment for major depressive disorder (“MDD”).

Hammersmith Medicines Research is leading the blinded, two-part Phase I/IIa clinical trial which commenced in Q1 2021. Phase I of the study aims to demonstrate the safety and tolerability of different dose levels of SPL026, a DMT fumarate, in psychedelic-naïve subjects when compared to placebo.  Phase IIa, the patient proof of concept, will assess the efficacy, safety and tolerability of one versus two doses of SPL026 in combination with psychotherapy, in patients with MDD. Efficacy will be assessed using the Montgomery-Asberg Depression Rating scale to measure the severity of depressive episodes.

The appointment of MAC Clinical Research (“MAC”), one of Europe’s largest independent clinical development organizations, expands the Phase IIa trial with an additional study site at Prescott, Liverpool in the UK, and will bring the total number of patients in the Phase IIa trial to 42. This patient proof of concept phase will commence in Q3 2021 and, as a result of appointing MAC, timelines for this Phase I/IIa clinical trial are expected to accelerate with anticipated top-line results brought forward from the end of 2022 to the first half of 2022.

Psychedelics have been shown to have therapeutic benefits in disorders such as depression, substance abuse and post-traumatic stress disorder. These so-called ‘internalizing disorders’ are characterized by debilitating flows of recurring negative thoughts. Clinical research suggests that DMT will break or disrupt the neuronal pathways that underlie these negative thought processes and by doing so, may facilitate the benefits of therapy given in combination with DMT. DMT-assisted therapy targets the root cause of depression and other ‘internalising’ conditions and has the potential to provide a treatment with rapid onset and a long duration of activity following treatment.

Small Pharma is a neuropharmaceutical company specialised in IP led development of novel treatments for mental health conditions, with a focus on depression. Small Pharma initiated a clinical program into DMT-assisted therapy in February 2021. This program includes a Phase I/IIa trial on its lead candidate alongside development of a robust pipeline of proprietary preclinical assets.

DMT is a naturally occurring chemical with psychoactive properties found in plants and in the brain of mammals. DMT is chemically similar to the neurotransmitter serotonin, which is involved in a variety of physiological functions in humans, including eating, sleep and mood regulation. Small Pharma has produced its own DMT-based product, SPL026, in line with good manufacturing practice guidelines laid down by agencies controlling authorisation and licensing of pharmaceutical products.

MAC Clinical Research is one Europe’s largest independent clinical development organisations with expertise across all phases of clinical trials, including experience in conducting trials with psychedelic drug candidates. MAC’s Contract Research Services are complemented with a fully owned network of Dedicated Research Sites providing extensive reach across the UK, EU and the US. MAC has a broad range of clinical research capabilities to accommodate the most complex Phase I trials through to Phase IV (across a network of late phase Dedicated Research Sites). The majority of MAC’s current work includes CNS diseases (e.g., Alzheimer’s and Parkinson’s diseases, depression, Anxiety and Multiple Sclerosis), Analgesics (acute and chronic pain), dermatology (psoriasis and atopic dermatitis), Rheumatology (fibromyalgia and arthritis), and Endocrinological diseases (e.g., diabetes type 1 &2).