Enveric Biosciences Selects EB-003 as Lead Drug Candidate from EVM301 Series
29 December 2023 - 12:00AM
Business Wire
Enveric to initiate preclinical development of
EB-003 in 2024 in preparation for IND submission
Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”),
a biotechnology company dedicated to the development of novel
neuroplastogenic small-molecule therapeutics for the treatment of
depression, anxiety, and addiction disorders, today announced that
it has named EB-003 as its lead drug candidate from the Company’s
next-generation EVM301 Series. EB-003 was selected based on data
analyses suggesting the molecule’s potential to be a first-in-class
approach to addressing difficult-to-treat mental health disorders
by promoting neuroplasticity without inducing hallucinations.
Enveric plans to initiate preclinical development of EB-003 in
early 2024 in preparation for an Investigational New Drug (IND)
application for a first-in-human clinical trial.
EB-003 was identified following a rigorous selection process
during which Enveric utilized its proprietary computational
chemistry and artificial intelligence (AI) drug-discovery platform,
PsyAI™, to simulate interactions between indolethylamine
derivatives and the 5-HT2A receptor to design novel molecules with
reduced head-twitch response (HTR) in mice. HTR is a rodent
behavioral model used to predict whether a molecule is likely to
produce hallucinogenic effects in humans. In total, 51 proprietary
indolethylamine analogs were screened, from which three candidates
were selected based on the molecules’ ability to bind to the 5-HT2A
receptor and induce neuroplasticity while eliciting no significant
HTR across a wide dose range.
From the top three candidates, EB-003 was chosen as lead based
on its superiority in numerous relevant measures.
EB-003:
- Demonstrated a low HTR profile in mice at all doses tested (up
to 10 mg/kg).
- Promoted neuroplasticity at a level similar to that induced by
the hallucinogenic positive control N,N-dimethyltryptamine
(DMT).
- Exhibited partial agonism of the 5-HT2A receptor, binding with
a Ki of 0.2 mM, which is within the range of binding affinity of
the known 5-HT2A agonists DMT and psilocin.
- Resulted in a return to pre-stressed behavior in both the
marble-burying (MB) and sucrose preference (SP) tests, which are
models for anxiety and depression, respectively, when administered
to mice at a dose of 10 mg/kg by intraperitoneal injection.
- Bound the 5-HT1A receptor with a Ki of 3.3 mM. 5-HT1A receptor
agonists and partial agonists have demonstrated clinical efficacy
at relieving anxiety and depression.
- Was not an agonist of the 5-HT2B receptor. 5-HT2B receptor
agonism can lead to cardiac valvulopathy and is therefore
considered a toxicity signal sufficient to preclude clinical
development.
- Showed moderate exposure in pharmacokinetic analysis with a
half-life of approximately 30 minutes, which is anticipated to
enhance optionality in the future determination of dosing
regimens.
- Revealed high membrane permeability in assays, indicating the
potential for excellent blood brain barrier permeability, an
important consideration for drugs that target receptors in the
brain.
- Overall toxicity parameters were similar to or below those for
DMT and psilocin.
“Selection of EB-003 as the lead development candidate from our
EVM301 Series is an important inflection point for Enveric and our
mission to develop groundbreaking, psychedelic-inspired drug
technologies that offer the potential to treat severe mental health
disorders without the hallucinogenic effect typically associated
with psychedelic-based molecules,” said Joseph Tucker, Ph.D.,
Director and CEO of Enveric. “Importantly, moving EB-003 into our
development pipeline marks a transformative step for Enveric as we
complete our period as a discovery phase company and fully
transition to the next phase as a drug development company. With
EB-003, we have identified a novel, neuroplastogenic molecule that
exhibits several key properties that align with favorable
tolerability and efficacy in relevant animal models. We now look
forward to initiating IND enabling activities in early 2024 that
will enable us to file an IND and start clinical trials of EB-003
as we seek to introduce a new treatment paradigm for depression and
anxiety disorders.”
About Enveric Biosciences
Enveric Biosciences (NASDAQ: ENVB) is a biotechnology company
dedicated to the development of novel neuroplastogenic
small-molecule therapeutics for the treatment of depression,
anxiety, and addiction disorders. Leveraging its unique discovery
and development platform, Psybrary™, Enveric has created a robust
intellectual property portfolio of New Chemical Entities for
specific mental health indications. Enveric’s lead program, the
EVM201 Series, comprises next generation synthetic prodrugs of the
active metabolite, psilocin. Enveric is developing the first
product from the EVM201 Series – EB-373 – for the treatment of
psychiatric disorders. Enveric is also advancing its second
product, EB-003, as a first-in-class approach to the treatment of
difficult-to-address mental health disorders by promoting
neuroplasticity without inducing hallucinations in the patient.
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 may include
historical statements and statements regarding beliefs, plans,
expectations, or intentions regarding the future and 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: carry out successful
clinical programs in Australia; achieve the value creation
contemplated by technical developments; avoid delays in planned
clinical trials; establish that potential products are efficacious
or safe in preclinical or clinical trials; establish or maintain
collaborations for the development of therapeutic candidates;
obtain appropriate or necessary governmental approvals to market
potential products; obtain future funding for product development
and working capital on commercially reasonable terms; scale-up
manufacture of product candidates; respond to changes in the size
and nature of competitors; hire and retain key executives and
scientists; secure and enforce legal rights related to Enveric’s
products, including patent protection; identify and pursue
alternative routes to capture value from its cannabinoid clinical
development pipeline assets; continue as a going concern; and
manage its future growth effectively.
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, 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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