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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.”
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.
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.
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Cautionary Note Regarding Forward-Looking Statements
This press release contains statements that constitute “forward-looking information” (“forward-looking information”) within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking information and are based on expectations, estimates and projections as at the date of this news release. Any statement that discusses predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information. Forward-looking statements in this news release include statements regarding the Company’s placebo-controlled, proof-of-concept Phase IIa study of SPL026 and the Company’s ability to develop solutions to effectively address depression through DMT-based therapies. In disclosing the forward-looking information contained in this press release, the Company has made certain assumptions. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, it can give no assurance that the expectations of any forward-looking information will prove to be correct. Known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking information. Such factors include, but are not limited to: compliance with extensive government regulations; domestic and foreign laws and regulations adversely affecting the Company’s business and results of operations; the impact of COVID-19; and general business, economic, competitive, political and social uncertainties. Accordingly, readers should not place undue reliance on the forward-looking information contained in this press release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking information to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking information or otherwise.
Small Pharma makes no medical, treatment or health benefit claims about its proposed products. The Medicines and Healthcare products Regulatory Agency (“MHRA”) or other similar regulatory authorities have not evaluated claims regarding DMT-assisted therapies and other next generation psychoactive compounds. The efficacy of such therapies have not been confirmed by MHRA-approved research. There is no assurance that such DMT-assisted therapies and other psychoactive compounds can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. Any references to quality, consistency, efficacy and safety of potential therapies do not imply that Small Pharma verified such in clinical trials or that Small Pharma will complete such trials. If Small Pharma cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Small Pharma’s performance and operations.
The TSX Venture Exchange (the “TSXV”) has neither approved nor disapproved the contents of this news release. Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.