CAMBRIDGE, Mass. — Enveric Biosciences announced positive results from a series of preclinical studies evaluating its lead drug candidate, EB-003, a non-hallucinogenic compound being developed to treat psychiatric and neurological disorders.
The biotechnology company said it completed investigational new drug (IND)-enabling in vitro absorption, distribution, metabolism, excretion and toxicity (ADMET) studies, generating additional data supporting the compound’s development and potential safety profile.
The studies involved more than 70 individual laboratory assays designed to assess how EB-003 may be absorbed, distributed, metabolized and eliminated by the body, as well as its potential interactions with other medications.
According to the company, the results indicated favorable intestinal absorption potential in human cell-based tests and limited plasma protein binding, suggesting potentially favorable drug distribution and clearance characteristics.
EB-003 also demonstrated stability when tested against liver metabolism enzymes from multiple species, including humans.
The studies found that the compound was not a substrate of key liver and kidney transporters under laboratory conditions, suggesting the potential for predictable systemic drug exposure and elimination.
Additionally, EB-003 did not significantly inhibit or induce major metabolic enzymes and multidrug transport proteins, potentially reducing the risk of drug-drug interactions.
“These results represent an important milestone in the development of EB-003, provide additional support for its preclinical development profile, and support its continued advancement toward a planned first-in-human clinical trial,” said Joseph Tucker, Ph.D., director and chief executive officer of Enveric.
“So far, the data generated from our IND enabling studies have showcased a differentiated pharmacological profile for EB-003, with the potential to preserve certain therapeutic benefits associated with neuroplasticity while minimizing safety concerns and hallucinogenic impacts.”
EB-003 is designed to promote neuroplasticity, the brain’s ability to reorganize and form new neural connections, without producing the hallucinogenic effects associated with certain psychedelic compounds.
The company said the latest findings further support the drug candidate’s advancement toward human clinical testing.
The results remain preclinical, and EB-003’s safety and effectiveness in humans have not yet been established.
