Enveric Biosciences Updates Key Data Underpinning Selection of EB-003 as Lead Drug Candidate from EVM301 Series

Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, and addiction disorders, today provided an update on data underpinning the selection of EB-003 as its lead drug candidate from the Company’s next-generation EVM301 Series. As previously announced, 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.

Importantly, EB-003:

• Exhibited partial agonism of the 5-HT2A receptor, binding with a K_i of 0.2 µM (micromolar), which is within the range of binding affinity of the known 5-HT2A agonists DMT and psilocin.
• Bound the 5-HT1A receptor with a K_i of 3.3 µM.

These data points correct previously announced information which stated 0.2 mM and 3.3 mM respectively and indicate a 1000x greater binding affinity compared to what was previously reported. 5-HT2A is the key receptor correlated to the neuroplastogenic activity of this emerging class of novel drugs. 5-HT1A is a known important therapeutic target because other, already-approved medications for neuropsychiatric indications are known to bind this receptor.

“Selection of EB-003 as the lead development candidate from our EVM301 Series is an important inflection point for Enveric, and the updated data highlight its potential to be a novel, neuroplastogenic molecule that exhibits several key properties that align with favorable tolerability and efficacy in relevant animal models,” said Joseph Tucker, Ph.D., Director and CEO of Enveric. “We 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.”

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 EB-003 was selected based on key properties including the molecule’s ability to bind to the 5-HT2A receptor and induce neuroplasticity while eliciting no significant HTR across a wide dose range.