Small Pharma Granted Fast-Track Designation From U.K. Regulator for DMT-Assisted Therapy for Major Depressive Disorder

Lead candidate SPL026 granted MHRA Innovation Passport Designation

LONDON, Oct. 21, 2021 (GLOBE NEWSWIRE) — Small Pharma Inc. (TSXV: DMT) (OTCQB: DMTTF) (the “Company” or “Small Pharma”), a neuropharmaceutical company focused on psychedelic-assisted therapies, is pleased to announce that following discussions with the U.K. Medicines and Healthcare products Regulatory Agency (the “MHRA”), Small Pharma has been granted an Innovation Passport Designation for SPL026, the lead product candidate from its pipeline of N,N-dimethyltryptamine (“DMT”) assisted therapies for the treatment of major depressive disorder (“MDD”).

Dr. Carol Routledge, Chief Medical and Scientific Officer of Small Pharma, said: “Similar to the FDA’s fast-track in the United States, the U.K.’s MHRA Innovation Passport provides us with access to specialist advice throughout the drug development process and has the potential to enable a speedier, more efficient development process for SPL026, the lead candidate in our psychedelic-assisted therapy approach for the treatment of MDD. SPL026 entered clinical trials at the beginning of 2021 and this designation marks an important step forward towards an accelerated drug approval pathway for bringing the benefits of SPL026 to market for patients suffering with MDD.”

The Innovation Passport is an innovative medicine designation that provides access to the Innovative Licensing and Access Pathway (the “ILAP”). The ILAP accelerates time to market and facilitates patient access to emerging and novel treatments. The ILAP provides a single integrated platform for sustained collaborative working among the MHRA, its partners and the medicine developer, which allows for enhanced coordination and monitoring of important product development activities culminating in market authorisation. Under the ILAP, Small Pharma will have access to a toolkit to support all stages of the design, development and approvals process, as well as identify key areas for future engagement.

ILAP partners with a number of key regulatory bodies in order to enable earlier engagement and support to the companies selected for the ILAP. This has the potential to allow the National Health Service England (the “NHS England”) to adopt potential treatments faster and ultimately enable quicker patient access to these potential medicines. Key partnering stakeholders include the MHRA, the U.K.’s public body responsible for evidence-based evaluations of novel treatments, the National Institute for Health and Care Excellence, as well as the NHS England, the Scottish Medicines Consortium, NHS Improvement Health Research Authority, and the National Institute for Health Research.

About Small Pharma

Small Pharma is a neuropharmaceutical company specialized in IP led development of novel treatments for mental health conditions, with a focus on depression. Small Pharma initiated a clinical program into DMT-assisted therapy in February 2021. This program includes a Phase I/IIa trial on its lead candidate alongside development of a robust pipeline of proprietary preclinical assets.

About DMT

DMT is a naturally occurring psychedelic tryptamine found in plants and in the brain of mammals. Scientific evidence suggests DMT offers the potential for rapid-acting and long-lasting antidepressant effects. DMT is differentiated by its short psychedelic experience (< 30mins), which allows for short treatment sessions and offers the potential for convenient supervised treatments within patient clinics. Small Pharma is advancing a pipeline of DMT-based therapies and is leading the world’s first DMT clinical trial for MDD, in collaboration with Imperial College London.

For further information contact:
 
Small Pharma Inc.
Peter Rands
Chief Executive Officer
Email: ir@smallpharma.co.uk
Tel: +44 (0)2071 129118

Media Relations Contact
McKenna Miller
KCSA Strategic Communications
Email: smallpharmapr@kcsa.com
Tel: +1 (949) 949-6585

Investor Relations Contacts
Eric Ribner
LifeSci Advisors
Email: eric@lifesciadvisors.com

Tim Regan/Adam Holdsworth
KCSA Strategic Communications
Email: smallpharmair@kcsa.com
Tel: +1 (347) 487-6788

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 success in launching a clinical program into DMT-assisted therapy, the potential of DMT-assisted therapies to transform the lives of patients suffering with MDD, the acceleration of SPL026’s time to market and facilitation of patient access to medicines for emerging and novel treatments, the Company’s access to a toolkit to support all stages of the design, development and approvals process, as well as to identify key areas for future engagement under the ILAP, and the Innovation Passport Designation providing potential access to speedier and more efficient development pathways for SPL026. 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 (the “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.