Enveric Biosciences Initiates GLP Toxicology & Safety Pharmacology Studies for Lead Candidate EB-373, a Next Generation Psilocin Prodrug Targeting Psychiatric Disorders
18 October 2023 - 11:00PM
Business Wire
Key preclinical milestone designed to establish
safety profile and maximum tolerated dose for anticipated clinical
trial of EB-373
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
initiation of Good Laboratory Practice (GLP)-toxicology and safety
pharmacology studies for lead prodrug candidate EB-373, the
company’s next generation psilocin prodrug being developed for the
treatment of psychiatric disorders.
Enveric has commenced preclinical studies to evaluate
repeat-dose toxicity in animals, which are designed to strengthen
the broad safety margin established in previous non-GLP studies and
are intended to generate regulatory-compliant data that will help
advance EB-373 to first-in-human clinical studies. Assessing the
safety and tolerability of repeated-dosing in preclinical studies
provides critical data to support repeat-dosing in future human
clinical trials, which may broaden the potential therapeutic
application of EB-373.
The GLP toxicology and safety studies are a final step as
Enveric prepares to enter clinical-stage trials with its novel,
next generation synthetic psilocin prodrug. Enveric previously
reported the results of non-GLP preclinical studies that showed a
favorable safety and tolerability profile of EB-373 and
demonstrated rapid conversion from prodrug to active metabolite
psilocin, with EB-373 blood concentrations approximately 100-fold
lower than psilocin, reducing to undetectable levels after two
hours. Notably, psilocin blood concentration peaked at one hour
after administration of EB-373 indicating a quicker onset of
effect.
“The GLP toxicology and pharmacology studies represent a
significant development milestone for our EB-373 program as we seek
to establish the safety profile and maximum tolerated doses, key
requirements for clinical trial application,” said Joseph Tucker,
Ph.D., Director and CEO of Enveric. “Based on prior preclinical
research, we expect the final safety profile of EB-373 to confirm
the compound’s ability to allow for repeat dosing, which would
support greater therapeutic applicability and presents an important
differentiator from other psilocin based therapeutics.”
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
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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 (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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