First patient dosed in Small Pharma’s Drug Interaction study
Open-label study will assess the interaction between SSRI antidepressants and SPL026
December 15, 2022 – London, United Kingdom – 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 confirms that the first patient has been dosed in the Company’s Phase Ib drug interaction study. The study aims to assess the interaction between selective serotonin reuptake inhibitors (“SSRIs”) and SPL026, the Company’s lead N, N-dimethyltryptamine (“DMT”) candidate, in patients with Major Depressive Disorder (“MDD”).
The open-label study is being conducted at two MAC Clinical Research sites in the United Kingdom and will investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, and exploratory efficacy of SPL026, alone or in combination with SSRIs, in up to 24 patients. The trial will assess a single dose of SPL026 in patients currently on a treatment course of SSRIs that have been ineffective in fully relieving their depression, compared to patients who are not currently using any pharmacological treatment to treat their depression. All patients will receive SPL026 with supportive therapy.
Dr. Carol Routledge, Chief Medical and Scientific Officer, said:
With the SSRI drug interaction study now fully underway, we look forward to the results which, if encouraging, have the potential to facilitate patient recruitment in additional Company trials by removing the requirement for patients to be withdrawn from their existing SSRI medication. In the longer term, successful results could expand patient access to SPL026 therapy.”
George Tziras, Chief Executive Officer, added: “We are approaching the end of 2022 with plenty of momentum as we prepare to initiate two additional clinical trials. We also expect to complete patient follow-ups in our lead SPL026 Phase IIa study by the end of the year, with results due soon afterwards.”
About Small Pharma
Small Pharma is a biotechnology company progressing a pipeline of short-acting psychedelic-assisted therapies for the treatment of mental health conditions. The Company’s current focus is on exploring new therapeutic approaches for depression. Small Pharma’s lead candidate, SPL026, is a proprietary synthetic formulation of DMT. The Company is advancing a clinical program of intravenous SPL026 with supportive therapy for the treatment of MDD, which was granted an Innovation Passport designation from the U.K. Medicines and Healthcare products Regulatory Agency (the “MHRA”). In addition, Small Pharma has a pipeline of proprietary preclinical assets in development.
For further information contact:
Small Pharma Inc.
George Tziras, Chief Executive Officer
Tel: +1 (646) 751-4363
Tel: +1 (646) 889-1200
Tel: +44 (0)7720 326 847
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 SSRI drug interaction study with SPL026, including the purpose, parameters and structure of the study, as well as the potential short-term and long-term impact of the study; the ability to facilitate patient recruitment and expand patient access to SPL026 therapy; statements related to the initiation of two additional clinical trials, the timing for completion of patient follow-ups and results for the Company’s lead SPL026 Phase IIa study; and the Company’s ability to progress short-acting psychedelic assisted therapies for the treatment of mental health conditions.
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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