Preclinical Data Demonstrates Therapeutic Efficacy of Enveric’s Lead Candidate
The company’s research in a well-established rodent model has shown that EB-003 has potential as an effective treatment for post-traumatic stress disorder, representing an opportunity in an underserved market.
Biotechnology company that is focused on developing novel neuroplastogenic small-molecule therapeutics, Enveric Biosciences, has announced that its lead molecule (EB-003) has demonstrated positive effects in the treatment of post-traumatic stress disorder (PTSD) in a preclinical model (1). The company is focusing on advancing EB-003 to clinical trials for the treatment of neuropsychiatric disorders.
“Only a few medications have been approved by the FDA for the treatment of PTSD, including the serotonin reuptake inhibitors (SSRIs) paroxetine and sertraline,” said Joseph Tucker, Ph.D., CEO and Director of Enveric, in a company press release (1). “Only 20% to 30% of PTSD patients experience full remission with these drugs and it takes two to three weeks of SSRI administration before clinical and neuronal benefits become apparent. Clearly, there is enormous unmet need in PTSD, which has yet to be addressed with meaningful innovation.”
The preclinical model comprised fear-conditioned mice, which is a well-established translational rodent model for PTSD. One hour after administering EB-003 orally to these mice, the researchers found that there was a significant decrease in context-induced freezing behavior. This outcome indicates a positive therapeutic effect with extinction of contextual fear after a single dose.
“Research has implicated impaired hippocampal neuroplasticity as key underlying features of patients struggling with PTSD,” added Tucker in the press release (1). “We are very encouraged that a single dose of our lead neuroplastogen, EB-003, facilitated rapid fear extinction in mice.”
As the new data have demonstrated a potential enhancement of hippocampal neuroplasticity without causing hallucinations, Enveric’s lead candidate has the potential to improve treatment outcomes for PTSD, which represents an opportunity in an underserved market. The results from the preclinical study are consistent with those observed with MDMA, which is a psychedelic controlled substance that has demonstrated clinical benefits in the treatment of PTSD in human trials.
Additionally, in June, the company revealed data that broadens the potential clinical indication scope of EB-003 (2). The additional data revealed that EB-003 also acts as an agonist of the serotonin receptor 5-HT1B. This receptor is a recognized therapeutic target for the treatment of several central nervous system conditions.
“The 5-HT1B receptor, found predominantly in the frontal cortex, basal ganglia and hippocampus, is a validated therapeutic target of some well-known CNS drugs,” commented Tucker in a company press release about the additional data (2). “Enveric previously announced positive pharmacology, in vitro safety and oral bioavailability data of EB-003, including achieving therapeutically relevant brain exposure in rodent models. The newly revealed ability to target 5-HT1B illustrates EB-003’s differentiated and multifaceted mechanism of action and broadens its utility and the range of potential target indications to pursue in future development.”
References
Enveric Biosciences. Enveric Biosciences Lead Drug Candidate EB-003 Demonstrates Positive Effects in Preclinical Model of Post-Traumatic Stress Disorder (PTSD). Press Release, July 15, 2025.
Enveric Biosciences. Enveric Biosciences Announces Data that Broadens Scope of Clinical Indication Potential for Lead Candidate EB-003. Press Release, June 24, 2025.