Small Pharma Inc. Expands Phase I/IIa Clinical Trial With Additional Study Site

Appointment of MAC Clinical Research to accelerate timeline of Phase I/IIa clinical trial of SPL026 for Major Depressive Disorder

LONDON, June 1, 2021 /PRNewswire/ -- Small Pharma Inc. (TSXV: DMT) (the "Company" or "Small Pharma"), a neuropharmaceutical company focused on psychedelic-assisted therapies, today announces the expansion of its Phase I/IIa clinical trial for its lead product, SPL026, a N,N-dimethyltryptamine ("DMT") based treatment for major depressive disorder ("MDD").

Hammersmith Medicines Research is leading the blinded, two-part Phase I/IIa clinical trial which commenced in Q1 2021. Phase I of the study aims to demonstrate the safety and tolerability of different dose levels of SPL026, a DMT fumarate, in psychedelic-naïve subjects when compared to placebo.  Phase IIa, the patient proof of concept, will assess the efficacy, safety and tolerability of one versus two doses of SPL026 in combination with psychotherapy, in patients with MDD. Efficacy will be assessed using the Montgomery-Asberg Depression Rating scale to measure the severity of depressive episodes.

The appointment of MAC Clinical Research ("MAC"), one of Europe's largest independent clinical development organizations, expands the Phase IIa trial with an additional study site at Prescott, Liverpool in the UK, and will bring the total number of patients in the Phase IIa trial to 42. This patient proof of concept phase will commence in Q3 2021 and, as a result of appointing MAC, timelines for this Phase I/IIa clinical trial are expected to accelerate with anticipated top-line results brought forward from the end of 2022 to the first half of 2022.

Psychedelics have been shown to have therapeutic benefits in disorders such as depression, substance abuse and post-traumatic stress disorder. These so-called 'internalizing disorders' are characterized by debilitating flows of recurring negative thoughts. Clinical research suggests that DMT will break or disrupt the neuronal pathways that underlie these negative thought processes and by doing so, may facilitate the benefits of therapy given in combination with DMT. DMT-assisted therapy targets the root cause of depression and other 'internalising' conditions and has the potential to provide a treatment with rapid onset and a long duration of activity following treatment.

Peter Rands, CEO of Small Pharma, said: "MAC's extensive good clinical practice experience, expertise and infrastructure will provide access to additional sites designed for clinical trials such as ours.  Working in combination with Hammersmith Medicines Research, we can dose more patients and accelerate our timelines to deliver proof of concept of our lead product, SPL026, through this Phase I/IIa clinical trial."

Carol Routledge, Chief Medical and Scientific Officer of Small Pharma, added: "With more than 300 million people globally suffering from depressive disorders[1], new treatments cannot come soon enough. Psychedelic-assisted therapy studies consist of drug treatment in combination with psychological therapy which require specialist facilities that can host both elements. MAC brings expertise in conducting clinical trials for psychedelic-assisted therapy along with appropriate facilities within Prescott. This enables faster throughput of patients to assess the impact of this much needed treatment for patients suffering with depression."

We are excited to be collaborating with Small Pharma on their safety and efficacy of DMT-based therapy in patients with moderate/severe MDD at our bespoke Liverpool research facilities for psychedelic research," said Dr. Mark Dale, CEO, and principal investigator, Dr. Paul Westhead. "In addition, we are looking forward to being a part of developing DMT and deuterium-enriched tryptamines in combination with psychotherapy as a potential rapid onset, sustained treatment for mental health disorders".

About Small Pharma

Small Pharma is a neuropharmaceutical company specialised 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 chemical with psychoactive properties found in plants and in the brain of mammals. DMT is chemically similar to the neurotransmitter serotonin, which is involved in a variety of physiological functions in humans, including eating, sleep and mood regulation. Small Pharma has produced its own DMT-based product, SPL026, in line with good manufacturing practice guidelines laid down by agencies controlling authorisation and licensing of pharmaceutical products.

About MAC

MAC Clinical Research is one Europe's largest independent clinical development organisations with expertise across all phases of clinical trials, including experience in conducting trials with psychedelic drug candidates. MAC's Contract Research Services are complemented with a fully owned network of Dedicated Research Sites providing extensive reach across the UK, EU and the US. MAC has a broad range of clinical research capabilities to accommodate the most complex Phase I trials through to Phase IV (across a network of late phase Dedicated Research Sites). The majority of MAC's current work includes CNS diseases (e.g., Alzheimer's and Parkinson's diseases, depression, Anxiety and Multiple Sclerosis), Analgesics (acute and chronic pain), dermatology (psoriasis and atopic dermatitis), Rheumatology (fibromyalgia and arthritis), and Endocrinological diseases (e.g., diabetes type 1 &2).

For further information contact: 

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

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 collaboration with MAC and the Company's success in launching a clinical program into DMT-assisted therapy. 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 Medicines and Healthcare products Regulatory Agency ("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 have 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. 

This news release does not constitute an offer to sell, or a solicitation of an offer to buy, any securities in the United States. Small Pharma's securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act") or any state securities laws and may not be offered or sold within the United States or to U.S. Persons unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.

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.

[1] STAR*D Trial: https://www.nimh.nih.gov/funding/clinical-research/practical/stard/allmedicationlevels.shtml