Enveric Biosciences (NASDAQ:ENVB) has completed manufacturing of drug material enabling the completion of preclinical work for EB-373 including all bioanalytical method validation, GLP toxicology and GLP safety pharmacology studies. Enveric will immediately commence remaining GLP studies to provide critical data required to initiate human trials for EB-373. The company expects to complete all remaining preclinical studies required for Human Research Ethics Committee submission in Australia before year-end 2023.
Enveric and its contract development and manufacturing organization partner worked together to optimize and scale up the manufacturing process for EB-373, successfully producing sub-kilogram amounts of the EB-373 salt form with 99% purity. With the high purity of EB-373 manufactured drug product, Enveric measured no controlled impurities within the analytical limit of quantitation. As a result of this high purity product, Enveric and its research partners will be able to handle and ship EB-373 without restrictive limitations required for controlled substances.
“We are excited to highlight the extremely high-quality formulation and manufacturing work of our team and partners as we take the final steps required to bring EB-373 into initial clinical trials,” stated Joseph Tucker, Ph.D., director and CEO of Enveric. “By eliminating the restrictive requirements of handling and shipping controlled substances, our research teams and partners will be able to work more efficiently, saving Enveric time and costs both now and in our future clinical trials.”
About EB-373
Enveric’s lead drug candidate, EB-373, is a new chemical entity, designed as a next-generation proprietary psilocin prodrug and developed leveraging the company’s Psybrary drug discovery platform to target anxiety disorders. In preclinical studies, EB-373 displayed efficient prodrug parameters, demonstrating rapid and complete generation of psilocin both in vitro and when orally administered.
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