Enveric Biosciences Selects Australian CRO, Avance Clinical, in Preparation for Phase 1 Study of EB-373
March 23 2023 - 6:30AM
Business Wire
EB-373, a proprietary psilocin prodrug, is on
track to start its first-in-human clinical trial in the fourth
quarter of 2023
Enveric Biosciences, Inc. (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 entered into an agreement with Avance
Clinical, an Australia-based contract research organization (CRO)
with US operations, for its planned Phase 1 clinical trial of
EB-373, the company’s lead candidate targeting the treatment of
anxiety disorders. The Phase 1 clinical trial is expected to
initiate in the fourth quarter of 2023.
Under the agreement, Avance Clinical will manage the Phase 1
clinical trial of EB-373 in coordination with Enveric’s newly
established Australian subsidiary, Enveric Therapeutics Pty, Ltd.
The Phase 1 clinical trial is designed as a multi-cohort,
dose-ascending study to measure the safety and tolerability of
EB-373. EB-373, a next-generation proprietary psilocin prodrug, has
been recognized as a New Chemical Entity (NCE) by Australia’s
Therapeutic Goods Administration (TGA) and is currently in
preclinical development targeting the treatment of anxiety
disorder.
“With our Australia subsidiary established, we are actively
preparing to initiate the planned Phase 1 trial of EB-373 and are
pleased to have Avance Clinical as our CRO partner, given the
company’s proven expertise and experience managing early-stage
clinical programs in Australia,” said Joseph Tucker, Ph.D.,
Director and CEO of Enveric Bioscience. “EB-373 has the potential
to bring much-needed innovation to the treatment of anxiety
disorder, which is underserved by current therapeutic options. We
are eager to evaluate the potential of EB-373 in this
first-in-human Phase 1 clinical trial as an initial step towards
building a broader pipeline of proprietary psilocin prodrugs and
other innovative, psychedelic-inspired compounds for a range of
mental health conditions.”
“We are excited to work with Enveric and are eager to leverage
the expertise we’ve gained from managing early-stage clinical
programs in Australia to empower the development of EB-373,” said
Dr. Jemma Lawson, Director of Clinical and Project Operations for
Avance Clinical. “We look forward to being a valued partner to
Enveric in the execution of the EB-373 clinical program and
ensuring the highest quality data is generated to support global
regulatory filings.”
About EB-373
Enveric’s lead drug candidate, EB-373, is a New Chemical Entity
(NCE), designed as a next-generation proprietary 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 the 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 to treat anxiety disorders. Enveric
is also advancing its third generation of therapeutics, the EVM301
Series, which aims to eliminate the psychedelic experience and
remove unwanted effects, reduce safety concerns, and offer a novel
and holistic approach to 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.
About Avance Clinical
Avance Clinical is the largest premium full-service Australian
and US CRO delivering quality clinical trials, with globally
accepted data, in Australia, New Zealand and the US for
international biotechs. The company’s clients are biotechs in their
early phases of drug development that need fast, agile, and
adaptive solution-oriented clinical research services. For more
information, please visit www.avancecro.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
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.
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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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