Small Pharma Receives Approval for First-In-Human Phase I Clinical Trial With SPL028

Rhea-AI Summary

Small Pharma has received approval from the U.K. Medicines and Healthcare products Regulatory Authority for a Phase I study of SPL028, an injectable deuterated DMT candidate. The study aims to assess safety, tolerability, and pharmacokinetics in healthy volunteers, initiating in H1 2023. SPL028 targets a short psychedelic experience of over 30 minutes, potentially addressing unmet needs in mental health. Multi-layered intellectual property protection covers various jurisdictions, ensuring a robust foundation for further development.

Positive

• Received approval for Phase I study of SPL028 from the MHRA and Research Ethics Committee.
• SPL028 aims for a >30-minute psychedelic experience, enhancing patient convenience.
• Multi-layered intellectual property protection with four patents granted and over 30 pending applications.

Negative

• None.

SPL028 is the Company’s injectable deuterated DMT candidate with multi-layered IP protection 
The Phase I study aims to assess the safety, tolerability, pharmacodynamics and pharmacokinetics of IM and IV administration of SPL028

LONDON, Oct. 31, 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 received approval from the U.K. Medicines and Healthcare products Regulatory Authority (the “MHRA”) and the Research Ethics Committee to initiate a Phase I study of SPL028, its proprietary deuterated N, N-dimethyltryptamine (“DMT”) candidate, with supportive therapy in healthy volunteers. Through the SPL028 program, Small Pharma is exploring a >30-minute short psychedelic experience aimed at optimizing patient convenience and expanding the therapeutic potential in depressive disorders and additional indications.

This SPL028 Phase I study is planned to be a randomized, placebo-controlled, blinded, dose-escalating study to be conducted at MAC Clinical Research in Manchester, England. It is designed to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of intramuscular (“IM”) and intravenous (“IV”) administration of SPL028, which is expected to allow Small Pharma to better understand the profile of SPL028 as a therapeutic candidate. The study is anticipated to initiate in H1 2023.

Dr. Carol Routledge, Chief Medical and Scientific Officer, said: “This is an exciting milestone as we prepare to enter our first-in-human clinical trial with our proprietary deuterated candidate, SPL028. The goal is to deliver a treatment with a more extended psychedelic experience compared to our lead candidate, SPL026, which is around 20 minutes, but still significantly shorter than the psychedelic experiences of psilocybin or LSD, which are between six and twelve hours. We anticipate that the results of this Phase I study will help us make a data-driven decision in selecting the dose and route of administration to take forward into potential future studies in patients.”

George Tziras, Chief Executive Officer, added: “Progressing our second candidate towards the clinic marks a significant step for Small Pharma. Our focus continues to be in evaluating short-acting psychedelic therapies due to their potential as scalable treatments, which we see as critical given the magnitude of the mental health crisis. We look forward to understanding more about the profile of SPL028 and its potential in addressing areas of unmet patient need within mental health. SPL028 has multi-layered intellectual property protection in multiple jurisdictions providing protection for Composition of Matter, synthesis, and injectable pharmaceutical formulations. The protection currently consists of four granted patents across the U.S., Canada, the U.K. and Europe and over 30 pending patent applications.”

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 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
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 proposed SPL028 Phase I study to be conducted in the U.K., including the proposed design of the study and anticipated timeline for initiation; the potential impact of the study on decision-making for future studies; 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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FAQ

What is the aim of the Phase I study for SPL028?

The Phase I study aims to assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of SPL028 administered via intramuscular and intravenous routes.

When is the SPL028 Phase I study expected to start?

The SPL028 Phase I study is anticipated to initiate in the first half of 2023.

What are the potential benefits of SPL028 for mental health?

SPL028 is designed to provide a short psychedelic experience that may improve treatment efficacy for depressive disorders and other mental health conditions.

How does SPL028's psychedelic experience compare to other treatments?

SPL028 is expected to offer a psychedelic experience lasting over 30 minutes, shorter than traditional treatments like psilocybin or LSD, which can last between six to twelve hours.

What intellectual property protections are in place for SPL028?

SPL028 has multi-layered intellectual property protection including four granted patents across the U.S., Canada, the U.K., and Europe, along with over 30 pending applications.