Enveric Biosciences Selects Development Candidates from EVM301 Series Based on Potential to Minimize or Eliminate the Hallucinogenic Effect of Psychedelic-Derived Compounds
06 December 2023 - 12:00AM
Business Wire
Three novel neuroplastic compounds identified
with plans to advance one into expedited preclinical development in
2024
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 identified three novel compounds from its EVM301 Series with
the potential to offer a first-in-class approach to address
difficult-to-treat disorders by promoting neuroplasticity without
inducing hallucinations. Enveric plans to select one of the
compounds for preclinical development early in 2024 in anticipation
of Investigational New Drug (IND) application for a first-in-human
clinical trial.
Enveric’s research team successfully narrowed the EVM301 Series
to three candidates with preclinical data indicating 5HT2A receptor
binding, induction of neuroplasticity, and positive stress recovery
outcomes in animal models showing no indication of hallucinations.
Enveric’s researchers leveraged the Company’s proprietary
computational chemistry and artificial intelligence (AI)
drug-discovery platform, PsyAI™ to simulate interactions between
indolethylamine derivatives and the 5HT2A receptor to design novel
molecules with reduced head-twitch response (HTR) in mice.
Predicted structures were initially screened for patentability and
freedom-to-operate to complement Enveric’s extensive intellectual
property portfolio covering indolethylamine structures and their
fields of use. From a pool of more than 100 designed molecules, 44
new chemical entities were synthesized and screened using the HTR
hallucination model. Most compounds displayed reduced HTR, and
three candidates that showed what is believed to be insignificant
HTR across a wide dose range, yet still induced neuroplasticity and
bound to the 5HT2A receptor, were selected.
The three candidates showed 5HT2A binding affinity between 1 and
3 micromolar, generally displayed partial agonism in functional
cell-based assays with respect to the 5HT2A-Gq pathway and promoted
robust structural neuronal plasticity from a single dose. Each
candidate was further assessed for numerous pharmaceutically
relevant criteria. Analysis on serum drawn from mice subjected to
intraperitoneal injection revealed diversity in the candidate
compound pharmacokinetic profiles, providing optionality for future
method of administration development. All three candidates
demonstrated acceptable assessments of cellular toxicity,
blood-brain barrier permeability, and differential binding to other
serotonin receptors and transporters. In mouse efficacy models, a
single 10 mg/kg dose of any of the three candidates promoted the
general recovery of stressed mice to non-stressed behaviors in
sucrose-preference and marble-burying models of depression and
anxiety, respectively, one day and one week after treatment.
“Our industry leading drug-design team has progressed Enveric’s
EVM301 Series of compounds significantly closer to the nomination
of a lead candidate for preclinical and subsequent clinical
development,” said Joseph Tucker, Ph.D., Director and CEO of
Enveric. “The pharmacologic profiles of the identified three
candidate compounds provide evidence that our design and screening
processes have discovered and isolated promising candidates with
the potential to offer significantly improved treatments for severe
and undertreated mental health disorders, which have seen little
innovation for decades. We are committed to aggressively pursuing a
thorough and expedited preclinical program in 2024 in preparation
for an IND application.”
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
program, the EVM301 Series, expected to offer a first-in-class, new
approach to the treatment of difficult-to-address mental health
disorders, mediated by the promotion of neuroplasticity without
also 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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