Biotechnology company Enveric Biosciences has selected EB-003 as its lead drug candidate from its EVM301 series for difficult-to-treat mental health disorders.

EB-003 was selected by the company based on data assessments indicating its potential to offer a first-in-class approach to treat these disorders.

It works by boosting neuroplasticity without causing hallucinations.

Preclinical development of the drug is anticipated to commence early next year, with plans to file an investigational new drug application for a first-in-human clinical trial subsequently for depression and anxiety disorder indications.

Enveric leveraged its computational chemistry and artificial intelligence (AI) drug-discovery platform, PsyAI, to screen 51 indolethylamine analogs.

The platform’s computational chemistry and AI capabilities were instrumental in identifying molecules that interact with the 5-HT2A receptor to induce neuroplasticity.

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Of the total analogs, three candidates were chosen with EB-003 standing out due to its comprehensive profile.

It demonstrated to have a low head-twitch response (HTR) at all tested doses, induced neuroplasticity comparable to N,N-dimethyltryptamine (DMT) and showed partial agonism of the 5-HT2A receptor with a binding affinity within the range of known agonists.

Additionally, EB-003 returned mice to pre-stressed behaviour in anxiety and depression models.

Toxicity parameters of the drug were in line with or lower than those for DMT and psilocin.

Enveric director and CEO Joseph Tucker said: “Selection of EB-003 as the lead development candidate from our EVM301 Series is an important inflection point for Enveric and our mission to develop groundbreaking, psychedelic-inspired drug technologies that offer the potential to treat severe mental health disorders without the hallucinogenic effect typically associated with psychedelic-based molecules.

“Importantly, moving EB-003 into our development pipeline marks a transformative step for Enveric as we complete our period as a discovery phase company and fully transition to the next phase as a drug development company.

“With EB-003, we have identified a novel, neuroplastogenic molecule that exhibits several key properties that align with favourable tolerability and efficacy in relevant animal models.”