Enveric Biosciences, a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, and addiction disorders, announced that it has named EB-003 as its lead drug candidate from the Company’s next-generation EVM301 Series. EB-003 was selected based on data analyses suggesting the molecule’s potential to be a first-in-class approach to addressing difficult-to-treat mental health disorders by promoting neuroplasticity without inducing hallucinations. Enveric plans to initiate preclinical development of EB-003 in early 2024 in preparation for an Investigational New Drug (IND) application for a first-in-human clinical trial.
EB-003 was identified following a rigorous selection process during which Enveric utilized its proprietary computational chemistry and artificial intelligence (AI) drug-discovery platform, PsyAI™, to simulate interactions between indolethylamine derivatives and the 5-HT2A receptor to design novel molecules with reduced head-twitch response (HTR) in mice. HTR is a rodent behavioral model used to predict whether a molecule is likely to produce hallucinogenic effects in humans. In total, 51 proprietary indolethylamine analogs were screened, from which three candidates were selected based on the molecules’ ability to bind to the 5-HT2A receptor and induce neuroplasticity while eliciting no significant HTR across a wide dose range.
“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,” said Joseph Tucker, Ph.D., Director and CEO of Enveric. “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 favorable tolerability and efficacy in relevant animal models. We now look forward to initiating IND enabling activities in early 2024 that will enable us to file an IND and start clinical trials of EB-003 as we seek to introduce a new treatment paradigm for depression and anxiety disorders.”
Enveric Biosciences (NASDAQ: ENVB) is a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, and addiction disorders. Leveraging its unique discovery and development platform, Psybrary™, Enveric has created a robust intellectual property portfolio of New Chemical Entities for specific mental health indications. Enveric’s lead program, the EVM201 Series, comprises next generation synthetic prodrugs of the active metabolite, psilocin. Enveric is developing the first product from the EVM201 Series – EB-373 – for the treatment of psychiatric disorders. Enveric is also advancing its second product, EB-003, as a first-in-class approach to the treatment of difficult-to-address mental health disorders by promoting neuroplasticity without inducing hallucinations in the patient. Enveric is headquartered in Naples, FL with offices in Cambridge, MA and Calgary, AB Canada
SOURCE: Businesswire