Small Pharma’s DMT-assisted therapy (SPL026) demonstrated to be well-tolerated and safe in psychedelic naïve volunteers

Dataset generated from Phase I enables the selection of the optimal dose of SPL026 to take forward into Phase IIa

Small Pharma’s Phase IIa clinical trial to explore the effectiveness of SPL026 in combination with psychotherapy for the treatment of Major Depressive Disorder has been initiated

LONDON, Sept. 21, 2021 (GLOBE NEWSWIRE) – Small Pharma Inc. (TSXV: DMT) (the “Company” or “Small Pharma”), a neuropharmaceutical company focused on psychedelic-assisted therapies, today announced both the successful completion of the Phase I part of the combined Phase I/IIa clinical trial and the initiation of the Phase IIa part in combination with psychotherapy of its lead candidate, SPL026, for the treatment of Major Depressive Disorder (“MDD”).

Peter Rands, CEO of Small Pharma, said: “We are delighted to have made such swift and excellent progress in the seven months since starting Phase I. The successful completion of Phase I means we can now truly assess SPL026 as a new potential treatment option for patients with MDD. There has been little innovation for patients suffering from MDD in the last few decades and SPL026 has the potential to change the mental health treatment landscape and provide a much-needed alternative therapy for patients.”

Dr. Carol Routledge, Chief Medical and Scientific Officer of Small Pharma added: “We have achieved a significant milestone in the development of SPL026. With a strong safety and tolerability profile, now demonstrated, we can move ahead with the first regulated clinical trial of DMT-assisted therapy in patients. These results lay the foundation for Small Pharma’s DMT-assisted therapy as a potential new paradigm in the treatment of MDD.”

The Study

In the world’s first regulated clinical trial for N,N-dimethyltryptamine (“DMT”)-assisted therapy in MDD, Small Pharma’s proprietary intravenous formulation of DMT was very well tolerated in individuals with no previous experience of psychedelics. The dose-escalating, placebo-controlled Phase I study of SPL026, which was administered in combination with supportive psychotherapy to 32 healthy psychedelic naïve volunteers, demonstrated a favorable safety profile with no serious adverse events reported to-date.

The Phase I study has generated a robust dataset on the pharmacokinetics of SPL026 using Good Laboratory Practices as well as on safety and tolerability. This combined data has enabled Small Pharma to select a dose of SPL026, which elicits a breakthrough psychedelic experience and is safe and well-tolerated, to take into patients in Phase IIa.

The Company has now initiated the blinded, randomised, placebo-controlled, proof-of-concept Phase IIa study of SPL026 in combination with psychotherapy in 42 patients with MDD. The study, being held at two UK clinical trial sites – Hammersmith Medicines Research and MAC Clinical Research – will assess the efficacy of one versus two doses of SPL026 in combination with psychotherapy in patients with MDD while furthering the Company’s safety and tolerability dataset. Efficacy will be assessed using the Montgomery-Asberg Depression Rating scale to measure any potential reduction in the patients’ depression. Topline results are anticipated in the first half of 2022.

About Small Pharma

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 the Company’s lead candidate alongside development of a robust pipeline of proprietary preclinical assets.

About DMT

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 (< 30mins), 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.

For more information, read the full press release: here