Enveric Biosciences (NASDAQ: ENVB), a biotech firm dedicated to pioneering innovative neuroplastogenic small-molecule therapeutics aimed at addressing anxiety, depression, and addiction disorders, has recently achieved a significant milestone. The company has successfully completed the manufacturing of drug material necessary to advance preclinical work on EB-373, which includes vital aspects such as bioanalytical method validation, GLP toxicology, and GLP safety pharmacology studies.

With the immediate commencement of the remaining GLP studies, Enveric is poised to gather essential data that will pave the way for human trials related to EB-373. The company's timeline involves completing all preclinical studies required for Human Research Ethics Committee (HREC) submission in Australia by the end of 2023.

Enveric collaborated closely with its contract development and manufacturing organization (CDMO) partner to optimize and scale up the manufacturing process for EB-373. The successful outcome of this collaboration resulted in the production of substantial amounts of the EB-373 salt form, boasting an impressive 99% purity level. Notably, this high-purity product eliminates the presence of controlled impurities within the quantifiable analytical range. Consequently, this advancement enables Enveric and its research partners to handle and transport EB-373 without the stringent restrictions associated with controlled substances.

Joseph Tucker, Ph.D., Director and CEO of Enveric, expressed enthusiasm about this achievement, highlighting the high-quality formulation and manufacturing efforts that have brought EB-373 closer to initial clinical trials. The elimination of restrictions around handling and shipping controlled substances is expected to enhance efficiency, streamline research efforts, and lead to cost savings for Enveric's current and future clinical trials.

EB-373, Enveric's flagship drug candidate, represents a New Chemical Entity (NCE) developed using the company's Psybrary™ drug discovery platform. The candidate is designed as an innovative psilocin prodrug targeting anxiety disorders. Preclinical studies have showcased EB-373's effectiveness as a prodrug, exhibiting rapid and complete psilocin generation both in vitro and through oral administration. Additionally, EB-373 demonstrated promising results in animal behavioral models of anxiety, indicating its potential as an anxiolytic with lasting benefits.

Enveric Biosciences, listed under the ticker symbol ENVB on NASDAQ, is dedicated to pioneering neuroplastogenic small-molecule therapeutics for anxiety, depression, and addiction disorders. Leveraging their proprietary discovery platform, The Psybrary™, the company has built a robust Intellectual Property portfolio of New Chemical Entities tailored for specific mental health indications. The lead program, EVM201 Series, comprises innovative synthetic prodrugs of psilocin's active metabolite. EB-373 is the primary product of the EVM201 Series, designed to target anxiety disorders. Enveric is also advancing its EVM301 Series, aimed at providing a novel approach to addressing challenging mental health disorders by promoting neuroplasticity without inducing hallucinations. The company is headquartered in Naples, FL, with additional offices in Cambridge, MA, and Calgary, AB, Canada. For more information, please visit www.enveric.com.

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