Small Pharma Completes Enrollment in Phase IIa DMT-Assisted Psychotherapy Clinical Trial in Patients With Major Depressive Disorder
Dosing for primary endpoint now complete
LONDON, Sept. 19, 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 completed enrollment in the Phase IIa clinical trial of its intravenous (“IV”) formulation of N, N-dimethyltryptamine (“DMT”) candidate, SPL026, with psychotherapy for the treatment of Major Depressive Disorder (“MDD”). This formulation recently received patent protection in the United States under patent no. 11,406,619 for injectable formulations of DMT based compounds.
The Phase IIa trial is a blinded, randomized, placebo-controlled, proof-of-concept study of IV SPL026 in combination with psychotherapy, evaluating the efficacy of a single active dose versus placebo at two weeks, and generating a safety and tolerability dataset of SPL026 in patients with MDD. In addition, all participants are rolled into a second phase of the study where they receive a dose of SPL026 with psychotherapy. Efficacy will be assessed using the Montgomery-Asberg Depression Rating scale to measure any changes in the patients’ depression symptoms.
Enrollment into the study and the required dosing for the primary endpoint is now complete. The final dosing session for the second phase of the study is expected to be completed within the next two weeks. All patients are subsequently followed-up for 12 weeks. Topline data is anticipated shortly thereafter.
Dr. Carol Routledge, Chief Medical and Scientific Officer of Small Pharma, said: “The enrollment completion of our Phase IIa trial is an exciting milestone in the development of SPL026. Following encouraging results from our Phase I trial on the safety and tolerability profile of SPL026, the main focus for Phase IIa is exploring treatment efficacy in MDD patients. The key question we are seeking to answer from this trial is whether SPL026 in combination with psychotherapy offers rapid antidepressant effects. The trial design allows us to further explore the potential durability of these effects, which will be informative to our understanding of the clinical potential of this treatment.”
George Tziras, Chief Executive Officer, added: “We are delighted to hit this critical milestone in our clinical development program. I would like to thank the team and our partners, including Imperial College London, for their dedication and effort in executing a robust placebo-controlled and blinded DMT-assisted psychotherapy patient study, as well as their commitment to the care of patients throughout this trial. With the last patient now enrolled, we eagerly await analysis of the study results, which will help to inform our plans to move forward into a larger international multi-site Phase IIb trial, and bring us one step closer to delivering potential novel therapies to those suffering with depression.”
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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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 anticipated results and timeline of the SPL026 Phase IIa trial; the Company’s anticipated launch of additional clinical trials; 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 U.K. 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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