First-in-human clinical trial investigating
Enveric’s lead product candidate, EB-373 targeting anxiety disorder
expected to initiate in the fourth quarter of 2023
Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”),
a biotechnology company dedicated to the development of novel
small-molecule therapeutics for the treatment of anxiety,
depression, and addiction disorders, today announced that it has
established Enveric Therapeutics Pty. Ltd., an Australia-based
subsidiary, to support the Company’s plans to advance its EVM201
Series, including lead candidate EB-373, towards the clinic.
Enveric Therapeutics will oversee the Company’s preclinical,
clinical, and regulatory activities in Australia, including ongoing
interactions with the local Human Research Ethics Committees (HREC)
and the Therapeutic Goods Administration (TGA), Australia's
regulatory authority.
Enveric’s lead drug candidate, EB-373, is a next-generation
synthetic New Chemical Entity (NCE) designed as a psilocin prodrug
and developed leveraging its Psybrary™ drug discovery platform.
Enveric expects to initiate a Phase 1 first-in-human clinical trial
investigating EB-373 targeting anxiety disorders in the fourth
quarter of 2023.
“Australia is an ideal location to advance the development of
EB-373, as well as additional future therapies generated from our
EVM201 and EVM301 Series, given the favorable clinical, regulatory
and cost-saving opportunities available to biotechnology companies,
particularly those advancing psychedelic-derived compounds for CNS
conditions,” said Joseph Tucker, Ph.D., Director and CEO of Enveric
Biosciences. “With the establishment of Enveric Therapeutics Pty.
Ltd., we now have a foothold in Australia that we expect will
enable us to efficiently and expeditiously advance our lead program
towards generating human data by early 2024.”
Australia has enacted several policies designed to enable more
efficient and cost-effective early-stage product development.
Clinical trials conducted under the Clinical Trial Notification
(CTN) Scheme or Clinical Trial Exemption (CTX) Scheme – the two
pathways endorsed by the TGA for administering clinical trials in
Australia – do not require an active Investigational New Drug (IND)
application to proceed. Further, The Australian Government’s
Research and Development Tax Incentive provides a 43.5 percent
rebate for every dollar spent on R&D. Additionally, Australian
regulators have recently advanced guidance intended to encourage
the development of psychedelic-derived prescription
therapeutics.i
“Research conducted in Australia offers high quality and
scientific rigor by leveraging strong local expertise and
regulatory policies designed to encourage innovation. This
forward-thinking approach has made the country an attractive option
for conducting early preclinical and clinical programs and
advancing psychedelic-inspired new therapeutics,” said Bob Dagher,
MD, Chief Medical Officer of Enveric Biosciences. “Given this, we
are eager to initiate our clinical development program of EB-373 in
Australia and look forward to benefiting from the country’s
high-quality clinical research sites.”
About EB-373
Enveric’s lead drug candidate, EB-373, is a New Chemical Entity
(NCE), designed as next-generation psilocin prodrug and developed
leveraging its Psybrary™ drug discovery platform to target anxiety
disorders. In preclinical studies, EB-373 interacted effectively
with different types of serotonin receptors, including the
serotonin 5-HT2A receptor resulting in the induction of the
characteristic head twitch response in mice. In an animal
behavioral model of anxiety, the Marble Burying Test in chronically
stressed mice, EB-373 was able to promptly rescue the rate of
marble burying on day 1 in line with the control rate at baseline,
with lasting benefits up to the end of experiment 7 days
post-dose.
About Enveric Biosciences
Enveric Biosciences (NASDAQ: ENVB) is a biotechnology company
dedicated to the development of novel small-molecule therapeutics
for the treatment of anxiety, depression, and addiction disorders.
Leveraging its unique discovery and development platform, The
Psybrary™, Enveric has created a robust Intellectual Property
portfolio of New Chemical Entities for specific mental health
indications. Enveric’s lead program, EB-373, is a next-generation
prodrug of psilocin, the active metabolite of psilocybin. EB-373 is
the lead drug candidate from the EVM201 Series currently advancing
through preclinical development for the treatment of anxiety
disorders. Enveric is also advancing its third generation of
therapeutics, the EVM301 Series, which aims at eliminating the
psychedelic experience and removing unwanted effects, reducing
safety concerns, and hence offering a novel and holistic approach
for treating central nervous system disorders. Enveric is
headquartered in Naples, FL with offices in Cambridge, MA and
Calgary, AB Canada. For more information, please visit
www.enveric.com.
Forward-Looking Statements
This press release contains forward-looking statements and
forward-looking information within the meaning of applicable
securities laws. These statements relate to future events or future
performance. All statements other than statements of historical
fact may be forward-looking statements or information. Generally,
forward-looking statements and information may be identified by the
use of forward-looking terminology such as “plans,” expects” or
“does not expect,” “proposed,” “is expected,” “budgets,”
“scheduled,” “estimates,” “forecasts,” “intends,” “anticipates” or
“does not anticipate,” or “believes,” or variations of such words
and phrases, or by the use of words or phrases which state that
certain actions, events or results may, could, would, or might
occur or be achieved. Forward-looking statements consist of not
purely historical statements, including any statements regarding
beliefs, plans, expectations, or intentions regarding the future.
Such forward-looking statements are based on the beliefs of
management as well as assumptions made by and information currently
available to management. Actual results could differ materially
from those contemplated by the forward-looking statements as a
result of certain factors, including, but not limited to, the
successful establishment of Enveric Therapeutics Pty. Ltd., the
ability of Enveric to successfully spin-off its cannabinoid assets;
the ability to achieve the value creation contemplated by technical
developments; the impact of the novel coronavirus (COVID-19) on
Enveric’s ongoing and planned clinical trials; the geographic,
social and economic impact of COVID-19 on Enveric’s ability to
conduct its business and raise capital in the future when needed;
delays in planned clinical trials; the ability to establish that
potential products are efficacious or safe in preclinical or
clinical trials; the ability to establish or maintain
collaborations on the development of therapeutic candidates; the
ability to obtain appropriate or necessary governmental approvals
to market potential products; the ability to obtain future funding
for developmental products and working capital and to obtain such
funding on commercially reasonable terms; Enveric’s ability to
manufacture product candidates on a commercial scale or in
collaborations with third parties; changes in the size and nature
of competitors; the ability to retain key executives and
scientists; and the ability to secure and enforce legal rights
related to Enveric’s products, including patent protection. A
discussion of these and other factors, including risks and
uncertainties with respect to Enveric, is set forth in Enveric’s
filings with the Securities and Exchange Commission (SEC),
including Enveric’s Annual Report on Form 10-K and its Quarterly
Reports on Form 10-Q. Enveric disclaims any intention or obligation
to revise any forward-looking statements, whether as a result of
new information, future events or otherwise, except as required by
law.
i
https://www.tga.gov.au/news/media-releases/change-classification-psilocybin-and-mdma-enable-prescribing-authorised-psychiatrists
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Investor Relations Tiberend Strategic Advisors, Inc.
Daniel Kontoh-Boateng (862) 213-1398 dboateng@tiberend.com
Media Relations Tiberend Strategic Advisors, Inc. Casey
McDonald (646) 577-8520 cmcdonald@tiberend.com
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