Enveric Biosciences Reports Year End Progress for Preclinical Development of Lead Prodrug Candidate EB-373
28 December 2023 - 12:00AM
Business Wire
The ongoing GLP Safety and Toxicology Program
of EB-373 is thus far proceeding on time with favorable results
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 the
GLP Safety and Toxicology Program of EB-373 is proceeding as
planned thus far with favorable results.
In-life portion of the repeat dose toxicology studies have been
completed, and the results are being analyzed. In addition,
cardiac, respiratory, CNS safety pharmacology studies, an in vitro
hERG current study, and genotoxicity studies have been completed
and are undergoing analyses. Enveric expects to finalize all
preclinical activities involving EB-373 in the first quarter of
2024 in preparation for a first-in-human clinical trial.
“Our research team has continued to diligently advance the
preclinical program for our lead novel psilocin prodrug, EB-373, as
we anticipate initiating first in human trials in 2024,” said
Joseph Tucker, Ph.D., Director and CEO of Enveric. “Analyses of
data collected to date have consistently confirmed the safety and
oral bioavailability of EB-373, with a dose-dependent increase in
EB-373 blood concentration detected followed by its rapid
conversion to the active metabolite psilocin. Further,
pharmacological properties observed in preclinical animal models
have validated our AI-backed molecular design aimed at optimal
control over the timing and length of the hallucinatory experience
in humans, while also achieving the desired therapeutic effect for
difficult-to-treat mental health indications.”
A summary of the EB-373 preclinical program is as follows:
- GLP toxicology studies of EB-373 in orally dosed rats and dogs
are currently in advanced stages, with all in-life activities
completed. Preliminary indications suggest a broad margin of safety
and tolerability is maintained with repeat dose testing. Complete
analysis and final reporting are expected by the end of Q1
2024.
- EB-373 safety pharmacology studies in rats and dogs, employing
the core battery of respiratory, CNS and cardiovascular (CV)
assessments, are completed. Preliminary results have demonstrated
an acceptable range of safety for each of these vital organ systems
in orally dosed animals. Complete analysis and final reporting are
expected by the end of December 2023.
- In vitro assessment of cardiotoxicity potential, involving
assays targeting key CV targets including hERG, Cav 1.2 and Nav 1.5
have been completed. Results suggest an acceptable range of
cardiovascular safety well above the proposed clinical dose
range.
- Non-GLP in vivo dose range finding (DRF) studies conducted in
rats and dogs, completed in August 2023, demonstrated effective
oral bioavailability of EB-373, with dose-dependent increase in
psilocin blood concentration detected in both species.
- Key outcomes from these PK assessments strongly suggest a broad
range of tolerance, with a potential for reduced gastrointestinal
(GI) upset and vomiting, as well as a rapid onset of action and
systemic clearance, improving on PK characteristics of
psilocybin.
- In vitro absorption, distribution, metabolism and excretion
toxicology (ADME-tox) studies and a metabolic identification
evaluation have been completed and confirmed minimal potential for
adverse drug reactions (ADR), with no toxic metabolites identified,
and no indication of any significant drug-drug interactions.
- Results from this study also demonstrated rapid conversion of
EB-373 to the active metabolite psilocin, consistent with
previously reported pharmacokinetic (PK) studies.
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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