First Patient Dosed in Small Pharma’s Phase I Study Exploring Intramuscular Administration of SPL026
Small Pharma Inc. has initiated a Phase I study comparing the safety and effectiveness of its proprietary psychedelic therapy, SPL026, administered intramuscularly (IM) versus intravenously (IV). This study, conducted in the UK, includes 14 healthy volunteers and aims to assess pharmacokinetics and pharmacodynamics, potentially improving treatment experiences for mental health conditions. Following the completion of a Phase IIa study for IV SPL026 in Major Depressive Disorder, results are expected shortly, guiding future clinical development.
- Initiation of Phase I study to compare IM and IV administration of SPL026.
- Phase IIa study of IV SPL026 in Major Depressive Disorder completed, with results anticipated soon.
- Potential for improved patient convenience and treatment experience with IM administration.
- Future efficacy of SPL026 remains uncertain until clinical data is fully analyzed.
- Regulatory approval for DMT-assisted therapies is not guaranteed, posing risks to commercialization.
Study will compare the profile of intramuscular versus intravenous SPL026 administration
LONDON, Jan. 09, 2023 (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 confirms that the first patient has been dosed in its Phase I study comparing the profiles of intramuscular (“IM”) and intravenous (“IV”) , the Company’s proprietary formulation of N, N-dimethyltryptamine (“DMT”).
The goal of the study, which is being conducted at Hammersmith Medicines Research Ltd. in the United Kingdom, is to compare the safety, tolerability, pharmacokinetics and pharmacodynamics of SPL026 delivered via IM versus IV administration, in up to 14 healthy volunteers.
Dr. Carol Routledge, Chief Medical and Scientific Officer, said: “IM injection of SPL026 may provide greater convenience for physicians, as well as potentially improve the treatment experience for some patients. This study seeks to identify a target dose of SPL026, administered via IM injection, that is well tolerated and delivers a consistent breakthrough psychedelic experience. By understanding parameters such as the duration and intensity of the psychedelic experience, we will be able to explore the potential application of IM SPL026 for treating mental health conditions.”
George Tziras, Chief Executive Officer, added: “Patient access is core to our mission. It is reflected in our decision to focus on short-duration psychedelics delivered through different administration routes, with the goal of maximizing patient reach and convenience. With the Phase IIa study of IV SPL026 in Major Depressive Disorder now completed, and results anticipated very soon, we are a step closer to understanding the potential efficacy of SPL026 as a depression treatment. These proof-of-concept results, combined with the results of our other SPL026 studies, will help guide our future clinical development and commercialization strategy.”
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 clinical programs of SPL026 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 intravenous 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
Email: ir@smallpharma.co.uk
Tel: +1 (646) 751-4363
Investor Relations Contacts:
Eric Ribner
LifeSci Advisors
Email: eric@lifesciadvisors.com
Tel: +1 (646) 889-1200
Media Relations Contacts:
Jaber Mohamed
MHP Communications
Email: smallpharma@mhpc.com
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 SPL026 IM/IV study, including the purpose, parameters, goals and structure of the study; the potential short-term and long-term impact of the study on the application of SPL026 and the treatment of mental health conditions; the benefits of IM injection for physicians and treatment experience; statements related to the Phase IIa study of IV SPL026 in Major Depressive Disorder, including the anticipated timeline for results and potential impact of the study on future development and strategy; 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.
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.
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