CAMBRIDGE, Mass.– Enveric Biosciences (NASDAQ: ENVB), a biotechnology company focused on developing next-generation neuroplastogenic small molecules for psychiatric and neurological disorders, announced the successful completion of several critical manufacturing milestones for its lead drug candidate, EB-003. These advancements represent major progress in the company’s chemistry, manufacturing, and controls (CMC) program and support the planned Investigational New Drug (IND) application and first-in-human clinical trials.
As part of its CMC efforts, Enveric has identified and produced a pharmaceutically compatible salt form of EB-003 aimed at improving drug stability and effectiveness. The company also established a scalable and reproducible synthetic route suitable for current and future manufacturing needs. Notably, Enveric has completed production of a 1-kilogram batch of EB-003 in its pharmaceutically compatible salt form to support upcoming IND-enabling studies, including GLP toxicology testing and formulation development.
“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 small-molecule drug candidate featuring dual agonist activity at the 5-HT1B and 5-HT2A receptors. The compound is being developed to address unmet needs in the treatment of neuropsychiatric conditions and is currently undergoing a comprehensive preclinical program. Completion of the CMC work enables Enveric to move forward with GLP toxicology studies and finalize drug product development activities necessary for IND submission.
“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.
