— Next Generation Psilocin Prodrug, EB-373, Nominated to Advances to IND-Enabling Studies —
—First Generation EVM101 Program for Cancer Related Distress has been discontinued —
Enveric Biosciences Inc. (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company dedicated to the development of novel small-molecule therapeutics for the treatment of anxiety, depression and addiction disorders, today announced the nomination of EB-373 as the lead development candidate to emerge from its EVM201 program. EB-373 is under development for the treatment of anxiety disorders.
The announcement of this important milestone coincides with the presentation of preclinical data from EVM201 program at the 6th International Neurology & Brain Disorders Conference (INBC) being held on October 24 – 26, 2022, in Orlando, Florida.
VALIDATION OF PLATFORM AND DEMONSTRATION OF PHARMACOLOGICAL ACTIVITY
The screening and optimization phase of the EVM201 program has yielded the lead drug development candidate, EB-373, which is currently advancing through several key preclinical studies that will lead to the filing of an Investigational New Drug (IND) application with the Food & Drug Administration (FDA), targeted to occur in the second half of 2023.
Data released today reveals for the first time that the Company’s engineered library of EVM201 drug candidates achieved an intended diversity of psilocin-releasing molecules, based on both in vitro assays and pharmacokinetic profiles in rodents. Additionally, all EVM201 drug candidates showed positive serotonin 5-HT2A receptor stimulation in vivo, revealed by induction of the characteristic Head Twitch Response (HTR) behavioural marker in healthy mice, and produced anxiolytic benefit in chronically stressed mice evaluated using the Marble Burying Test, an animal behavioral model of anxiety.
“The successful outcomes from our synthesis and screening efforts completed during 2022 have positioned the Company very well to advance our drug candidates towards the clinic,” stated Bob Dagher, MD, Chief Medical Officer of Enveric Biosciences. “This announcement marks a major step forward in demonstrating the utility of our technology platform. The nomination of EB-373 as lead candidate opens the door to our mission of delivering on the promise of novel therapies that offer new hope to patients living with common, difficult-to-treat, psychiatric diseases such as anxiety disorders.”
FOCUS ON NEXT GENERATION CANDIDATES, DISCONTINUATION OF 1st GENERATION PROGRAM
Due to the promising early data from the EVM201 program, the need for work on the original EVM101 classic psilocybin study has been obviated. As such, the first generation EVM101 program of psilocybin targeting Cancer Related Distress has been discontinued.
Enveric Biosciences (NASDAQ: ENVB) is a biotechnology company dedicated to the development of novel small-molecule therapeutics for the treatment of anxiety, depression and addiction disorders. For more information, please visit www.enveric.com.
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