Study will explore the interaction between SSRI antidepressants and SPL026, potentially broadening patient reach to those currently taking a SSRI
LONDON, Aug. 15, 2022 (GLOBE NEWSWIRE) -- Small Pharma Inc. (TSXV: DMT) (OTCQB: DMTTF) (the “Company” or “Small Pharma”), a biotechnology company focused on short-acting psychedelic-assisted therapies for mental health conditions, today announces that it has received approval from the U.K. Medicines and Healthcare products Regulatory Authority (the “MHRA”) and the Regional Ethics Committee to initiate a drug interaction clinical trial in the U.K. The study will assess the interaction between serotonin reuptake inhibitors (“SSRIs”) and SPL026, the Company’s lead N, N-dimethyltryptamine (“DMT”) candidate, in patients with Major Depressive Disorder (“MDD”).
This study is being conducted at two MAC Clinical Research sites and will assess the impact of SSRIs on the safety, tolerability, pharmacokinetics and pharmacodynamics of SPL026 with psychotherapy in up to 24 patients. These endpoints will be assessed in patients with MDD who are currently on a treatment course of a SSRI that is ineffective in fully relieving their depression, compared with patients not currently on a prescribed SSRI. The trial is expected to begin in Q3 2022, with dosing completion anticipated in H1 2023.
Dr. Carol Routledge, Chief Medical and Scientific Officer, said: “In the Phase I/IIa SPL026 clinical trial currently underway, patients must be withdrawn from existing antidepressant medication, which can be disruptive and unsettling for some. This may not always be in the best interest of patients, even if the medication is ineffective. Encouraging results from this study could facilitate patient recruitment in future clinical trials as patients may no longer be required to discontinue their SSRI medication. In the longer term, successful results could open up the potential to broaden patient accessibility to DMT-assisted psychotherapy.
George Tziras, Chief Executive Officer, added: “Patient access is a core element of Small Pharma’s values and strategy, which is reflected in our approach to research and development. As we progress through our clinical programs, it’s key that we are agile and most importantly patient-led.”
About Small Pharma
Small Pharma is a biotechnology company progressing a pipeline of short-acting psychedelics with therapy for the treatment of mental health conditions, with a current focus on depression. Small Pharma initiated a clinical program into DMT assisted psychotherapy in February 2021. This program includes a Phase I/IIa trial on the Company’s lead candidate alongside the development of a 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 (< 30 mins), which allows for short treatment sessions and offers the potential for convenient supervised treatments within patient clinics.
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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 proposed drug interaction study to be conducted in the U.K., including the anticipated timeline for initiation and completion of dosing and the potential impact of positive results on patient recruitment and accessibility; 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 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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