Discussions With FDA Provide Guidance For Phase IIb Clinical Trial Design For DMT-assisted Therapy For Major Depressive Disorder
FDA discussions pave pathway for U.S. clinical trial preparations
LONDON, Nov. 15, 2021 — Small Pharma Inc. (TSXV: DMT) (OTCQB: DMTTF) (the “Company” or “Small Pharma”), a neuropharmaceutical company focused on psychedelic-assisted therapies, today confirms, following positive discussions with the U.S. Food and Drug Administration (the “FDA”), that preparations are now underway for the U.S. component of its Phase IIb clinical trial for its lead candidate, SPL026, a N,N-dimethyltryptamine (“DMT”) assisted therapy for the treatment of major depressive disorder (“MDD”).
Dr Carol Routledge, Chief Medical and Scientific Officer of Small Pharma, said:
Discussions with the FDA are always a critical element in any clinical program planning, and we are delighted with the outcome. The discussions were quite wide ranging, from manufacturing and non-clinical elements to providing guidance on the Phase IIb clinical trial design to be conducted in patients with MDD. Importantly, the FDA’s feedback facilitates a path forward to prepare for the inclusion of U.S. sites in our Phase IIb clinical trial, which we anticipate will also be conducted across sites in Europe and the U.K. We believe that Small Pharma is conducting the first clinical trials of a DMT-assisted therapy for patients with MDD, with the potential to provide a much-needed alternative treatment for patients suffering from this debilitating condition.”
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 N,N-dimethyltryptamine (“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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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 potential for 6-HNK to deliver rapid antidepressant effects and an improved side effect profile to ketamine as an antidepressant, the Company’s ability to securely investigate the commercial potential of SPL801B, the Company’s ability to innovate and develop novel treatment candidates for mental health conditions through ketamine-based candidates, 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 has 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.
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