First Subject Dosed in Small Pharma’s First-in-Human Phase I Clinical Trial with SPL028
– SPL028 is a proprietary deuterated DMT candidate with multi-layered IP protection
– Phase I study will compare two routes of SPL028 administration; intravenous and intramuscular
February 15, 2023 – London, United Kingdom – Small Pharma Inc. (TSXV: DMT) (OTCQB: DMTTF) (the “Company” or “Small Pharma”), a biotechnology company focused on short-duration psychedelic-assisted therapies for mental health conditions, today confirms that the first subject has been dosed in a Phase I study evaluating SPL028, its deuterated N, N-dimethyltryptamine (“DMT”) candidate, with supportive therapy in healthy volunteers. This is the first-in-human trial investigating the profile of SPL028, the Company’s with Composition of Matter protection.
Small Pharma’s preclinical studies suggest that SPL028 offers a similar safety and pharmacological profile to its lead candidate SPL026, or DMT, while being differentiated by its pharmacokinetics. The Company aims to deliver a treatment with an extended psychedelic experience in comparison to 20-25 minutes with SPL026, but still significantly shorter than the experience of other psychedelics, such as psilocybin and lysergic acid diethylamide (LSD). Through the SPL028 clinical program, Small Pharma is exploring whether an extended duration could offer a treatment tailored for other mental health conditions in addition to depression. Additionally, the pharmacokinetic profile of SPL028 offers the opportunity to explore additional routes of administration, potentially expanding patient convenience.
The Phase I study is a randomized, blinded, placebo-controlled, dose-escalating study being conducted at MAC Clinical Research in Manchester, England. It is designed to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of both intravenous (“IV”) and intramuscular (“IM”) administration of SPL028.
Dr. Carol Routledge, Chief Medical and Scientific Officer, said:
With the SPL028 trial now underway, we look forward to learning more about its pharmacokinetic and pharmacodynamic properties in humans. Comparison of the IM and IV routes of administration in this study aims to create options for patients and physicians, which may help to expand convenience and accessibility. We expect that the results from this Phase I study will enable us to make a data-driven decision in selecting the dose and route of administration to take forward into a patient study.”
George Tziras, Chief Executive Officer, added: “This is a significant milestone for Small Pharma, with our second key program now in clinical development. The recent announcement on January 25, 2023 of our positive Phase IIa results demonstrates proof-of-concept for SPL026 in treating major depression. These encouraging results also provide support for our portfolio of DMT-based assets, and give us confidence in driving forward both our SPL026 and SPL028 programs.”
About Small Pharma
Small Pharma is a biotechnology company progressing a pipeline of short-duration 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 clinical programs of SPL026 and SPL028 with supportive therapy for the treatment of mental health conditions, and was granted an Innovation Passport designation from the U.K. Medicines and Healthcare products Regulatory Agency (the “MHRA”) for IV SPL026 with supportive therapy for Major Depressive Disorder. 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 Phase I SPL028 IV/IM clinical trial, including the purpose and intent of the study; the potential short-term and long-term impact of the study on the application of SPL028 for the treatment of mental health conditions and expanding patient convenience and accessibility; statements related to a future SPL028 patient study following completion of this trial; and the Company’s ability to progress short-duration 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.
The TSX Venture Exchange (“TSXV”) has neither approved nor disapproved the contents of this news release. Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.