LONDON, June 1, 2021 /CNW/ -- 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
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SOURCE Small Pharma Inc.