Small Pharma To Support University College London Research Project on Neuroplasticity

Rhea-AI Summary

Small Pharma will provide SPL026, a form of DMT, to support a University College London study examining psychedelic effects on cognition and brain function. The UNITy Project aims to uncover how DMT affects neuroplasticity over nine months using fMRI technology. Dr. Ravi Das, leading the project, emphasized the significance of understanding the mechanism behind psychedelic treatments for mental health. Small Pharma highlights its commitment to advancing treatment options for conditions like Major Depressive Disorder, backed by an Innovation Passport from the MHRA.

Positive

• Small Pharma is providing SPL026 for a significant research study, potentially advancing understanding of DMT's effects.
• The UNITy Project aims to explore DMT's impact on neuroplasticity, which could inform future therapies.
• The company has an Innovation Passport designation from the UK Medicines and Healthcare products Regulatory Agency for SPL026.

Negative

• None.

Small Pharma will provide SPL026 for the brain-imaging study, which seeks to explore how psychedelic-induced brain changes impact cognition, behaviour and well-being

LONDON, Dec. 14, 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 will provide its drug candidate SPL026, an intravenous formulation of the psychedelic drug N, N-dimethyltryptamine (“DMT”), to support a University College London (“UCL”) led study investigating induced brain changes and neuroplasticity following intravenous DMT.

The Understanding Neuroplasticity Induced by Tryptamines (UNITy) Project (the “UNITy Project”) is a longitudinal brain-imaging study being conducted by the UCL department of Psychology and Language Science, which seeks to provide a mechanistic understanding of how DMT impacts brain function, behaviour and well-being. The UNITy Project will use Functional Magnetic Resonance Imaging (fMRI) to image the brain before, during and after a DMT or placebo infusion. Follow-ups with study participants will occur for up to nine months.

Dr. Ravi Das, Associate Professor at University College London and Principal Investigator on the UNITy Project, said: “We are grateful that Small Pharma is providing its drug candidate, SPL026, to the UNITy Project. There is an urgent need for new, effective and lasting mental health treatments. While previous clinical research into psychedelics has been promising, there is a lack of mechanism-focused, well-controlled research into how, why and in whom these drugs work. We expect that this project will take major steps forward in progressing our understanding of how DMT affects the brain and behaviour.”

Dr. Carol Routledge, Chief Medical and Scientific Officer at Small Pharma, added: “Driving forward scientific research and excellence is really important to Small Pharma, so we are delighted to support UCL on this large-scale neuroimaging study. We hope the findings will provide us with an increased understanding of the mechanistic effects of DMT in the brain, as well as which patient populations could benefit most from DMT-based therapies.”

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
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 UNITy Project, including the design, parameters and follow-ups to the study; the potential impact of the UNITy Project’s findings in understanding DMT’s effect on the brain and benefits to certain patient populations; 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.

FAQ

What is the purpose of the UNITy Project involving DMT?

The UNITy Project aims to study how psychedelic-induced brain changes affect cognition and behavior using SPL026.

Who is conducting the study on DMT at University College London?

The study is led by Dr. Ravi Das, an Associate Professor at University College London.

What is Small Pharma's role in the UNITy Project?

Small Pharma is providing its drug candidate SPL026 to support the brain-imaging study.

When was the press release regarding the UNITy Project published?

The press release was published on December 14, 2022.

What designation has SPL026 received from the MHRA?

SPL026 has been granted an Innovation Passport designation from the UK Medicines and Healthcare products Regulatory Agency.