Training program established ahead of Phase II clinical trials
Phase IIa due to start imminently and Phase IIb expected to commence in 2022
LONDON, July 21, 2021 /PRNewswire/ -- Small Pharma Inc. (TSXV: DMT) (the "Company" or "Small Pharma"), a neuropharmaceutical company focused on psychedelic-assisted N,N-dimethyltryptamine ("DMT") therapies, has launched a training program to educate psychologists on the process required for the support and completion of Small Pharma's DMT-assisted therapy clinical trials.
Carol Routledge, Chief Medical and Scientific Officer of Small Pharma, added: "With the Phase IIa part of our initial trial due to start imminently, and our Phase IIb clinical trials due to commence in 2022, the Small Pharma training program will ensure psychologists participating in our trials are fully trained and understand the requirements stipulated by the regulatory authorities. We believe that DMT has the potential to transform the lives of millions of patients suffering with depression. The creation of our program will not only prepare psychologists for our trials, but we hope will be the beginning of a future standard training academy, increasing awareness of the importance of psychedelic-assisted therapy and supporting the future commercialisation of our products."
DMT-assisted therapy studies consist of drug treatment in combination with psychological therapy in specialist facilities that can host both elements. Small Pharma hosted and successfully completed the initial training program at the University of Oxford. It has been designed to train qualified therapists on the psychedelic-assisted therapy model that Small Pharma has been developing through its Phase I/IIa clinical trial at Hammersmith Medicines Research Ltd in collaboration with the Centre for Psychedelic Research at Imperial College London. The program consisted of sessions with key experts in the field including those from Imperial College London, King's College London, and the Institute of Psychedelic Therapy. This was the first of many sessions to be rolled out by Small Pharma to ensure that the support their patients receive in ongoing and future clinical trials is of the highest quality and administered consistently across the Company's global sites.
Psychedelics have been shown to have therapeutic benefits in disorders such as depression, anxiety, 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 disrupt the neuronal pathways underlying 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 "internalizing" conditions and has the potential to provide a treatment with rapid onset and a long duration of activity following treatment.
About Small Pharma
Small Pharma is a neuropharmaceutical company specialized 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.
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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 success in launching a clinical program into DMT-assisted therapy, the Company's development of a robust pipeline of proprietary preclinical assets, the potential of DMT to transform the lives of millions of patients suffering with depression, the Company's training program and the results thereof, and the commencement of the Company's Phase IIa and Phase IIb clinical trials. 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.
This news release does not constitute an offer to sell, or a solicitation of an offer to buy, any securities in the United States. Small Pharma's securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act") or any state securities laws and may not be offered or sold within the United States or to U.S. Persons unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.
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SOURCE Small Pharma Inc.