Key CMC achievements advance EB-003 on the path to first-in-human trials
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company advancing next-generation neuroplastogenic small molecules to address psychiatric and neurological disorders, today announced significant progress in the chemistry, manufacturing, and controls (CMC) development of its lead candidate, EB-003. Important steps in scaling production and preparing the drug for required regulatory activities have been achieved, advancing EB-003 toward the critical milestone of initiating human clinical trials.
As part of its CMC program, Enveric has recently completed the following key activities:
- Identified and produced a pharmaceutically compatible salt form designed to potentially improve drug effectiveness and stability
- Developed and implemented a scalable, reproducible synthetic route for EB-003 suitable for both current and future manufacturing needs
- Successfully produced a 1-kilogram batch of EB-003 as a pharmaceutically compatible salt to support upcoming Investigational New Drug (IND) application activities, including GLP toxicology studies and drug product formulation work
“These manufacturing and formulation milestones are essential for positioning EB-003 to enter clinical development,” said Joseph Tucker, Ph.D., Chief Executive Officer of Enveric Biosciences. “By demonstrating that EB-003 can be synthesized at scale in a pharmaceutically acceptable salt form and manufactured in kilogram quantities, we are reducing development risks and accelerating our path to human trials.”
EB-003 is a differentiated therapeutic candidate, with dual agonism at 5-HT1B and 5-HT2A receptors, designed to address unmet needs in the treatment of neuropsychiatric conditions. The novel small-molecule is being advanced through a rigorous preclinical program, with IND-enabling studies ongoing. Completion of the current CMC work is a critical step for Enveric to initiate GLP toxicology studies and finalize drug product development activities.
“These advancements, combined with our preclinical data, continue to build momentum for EB-003 as we move closer to first-in-human studies,” added Dr. Tucker.
About Enveric Biosciences
Enveric Biosciences (NASDAQ: ENVB) is a biotechnology company focused on developing next-generation, small-molecule neuroplastogenic therapeutics that address unmet needs in psychiatric and neurological disorders. By leveraging a differentiated drug discovery platform and a growing library of protected chemical structures, Enveric is advancing a pipeline of novel compounds designed to promote neuroplasticity without hallucinogenic effects. Enveric’s lead candidate, EB-003, is the first known compound designed to selectively engage both 5-HT₂A and 5-HT₁B receptors to deliver fast-acting, durable antidepressant and anxiolytic effects with outpatient convenience.
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,” “proposes,” “budgets,” “explores,” “schedules,” “seeks,” “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, should, would, or might occur or be achieved. Forward-looking statements may include 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: finalize and submit its IND filing to the U.S. Food and Drug Administration; carry out successful clinical programs; 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 research and 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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