Full Press Release Details
Biosciences Initiates GLP Toxicology & Safety Pharmacology Studies for Lead Candidate EB-373, a Next Generation Psilocin Prodrug
Targeting Psychiatric Disorders
preclinical milestone designed to establish safety profile and maximum tolerated dose for anticipated clinical trial of EB-373
Mass., October 18, 2023 - 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 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
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.
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.
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, which are 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."
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.
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
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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
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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