Small Pharma Announces Completion of SPL026 Phase IIa Trial and Secures New Intellectual Property
– Last patient last visit complete in SPL026 Phase IIa clinical trial with topline results expected early in Q1
– European patent granted for synthetic manufacturing process of key pipeline candidates
December 22, 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 announces that the last patient has completed its final visit in the Phase IIa clinical trial of SPL026, intravenous N,N-dimethyltryptamine (“DMT”), with supportive therapy, for the treatment of Major Depressive Disorder (“MDD”).
Dr. Carol Routledge, Chief Medical and Scientific Officer, said:
The last patient visit marks a significant milestone in our clinical program for SPL026. We will now move rapidly into data analysis, and plan to report the key trial results within weeks. This is the first completed placebo-controlled patient study to date exploring a short-acting psychedelic as a potential treatment for MDD, and we eagerly anticipate the results.”
The proof-of-concept Phase IIa clinical trial investigates intravenous SPL026 with supportive therapy, in MDD patients. This two-staged study included a blinded, randomized, placebo-controlled phase, where the primary endpoint was to assess the efficacy of a single dose of SPL026 versus placebo. In addition, all participants were rolled into an open-label phase of the study where they each received an active dose of SPL026 and were subsequently followed-up for 12 weeks. This trial design enables the assessment of secondary endpoints including the efficacy, safety, and tolerability of one versus two doses of SPL026. Efficacy is being assessed using the Montgomery-Asberg Depression Rating scale to measure any potential change in patients’ depression.
European Patent Grant
On December 21, 2022, the Company was granted patent no. 3 873 883 by the European Patent Office. The European patent protects a manufacturing process for the preparation of synthetic DMT, DMT-related compounds and deuterated DMT analogs. The claimed novel manufacturing process produces an efficient, Good Manufacturing Practice (GMP) compatible formula, that is inexpensive to manufacture and scalable for commercial purposes.
The European patent covers the preparation of the Company’s pipeline candidates SPL026 and SPL028. This patent marks the first grant within the Company’s synthetic route patent family, with patent applications pending in multiple additional jurisdictions, including the United States and Canada.
George Tziras, Chief Executive Officer, added:
Innovation is a key pillar of our Company strategy, and we have made great strides this year in protecting the intellectual property portfolio surrounding our innovation. The grant of this latest European patent brings us to 14 granted patents in total, including key grants within each of our core areas of patent protection. We close out 2022 with great momentum, and we look forward to continuing this trajectory into 2023.”
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 Major Depressive Disorder, which was granted an Innovation Passport designation from the U.K. Medicines and Healthcare products Regulatory Agency (“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 SPL026 Phase IIa clinical trial, including the timing for receipt of topline results and completion of data analysis, and benefits of the trial design; statements regarding the granting, and protection afforded by, patent no. 3 873 883 by the European Patent Office; the pending patent applications in Canada and the United States within the Company’s synthetic route patent family; 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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