Enveric Biosciences announced positive preclinical results for its lead neuroplastogen drug candidate EB-003, demonstrating statistically significant antidepressant effects in a well-established mouse model of severe chronic depression. The biotechnology company reported that EB-003 showed rapid therapeutic onset and maintained a clean safety profile during extended dosing studies.
Rapid Antidepressant Effects in Preclinical Model
In the Open Space Forced Swim Test, a validated psychiatric behavioral model designed to induce chronic depression-like states in mice, EB-003 demonstrated significant therapeutic efficacy. An oral dose of 30 mg/kg significantly reduced depression-like behavior within 30 minutes of administration, as indicated by enhanced distance traveled and reduced immobility during forced swim sessions (p-value < 0.01).
The therapeutic effects observed with EB-003 were comparable to those of imipramine, an approved tricyclic antidepressant drug. A repeat study conducted by the same third-party laboratory produced consistent results, confirming 30 mg/kg as an efficacious oral dose while showing no adverse locomotor effects at this dose level.
Safety Profile Supports Chronic Administration
The preclinical studies included a preliminary assessment of extended daily dosing to evaluate potential safety concerns for chronic therapeutic use. Mice receiving daily oral doses of EB-003 at 30 mg/kg for 22 days showed no adverse behavioral, physiological, or neurological effects. These observations demonstrate acceptable tolerance to long-term systemic drug exposure and expand the range of potential dosing strategies for EB-003.
"We are encouraged by these statistically significant and biologically meaningful results in a severe chronic depression animal model," said Dr. Joseph Tucker, CEO of Enveric Biosciences. "EB-003 has now demonstrated strong behavioral efficacy and a clean safety profile in several animal models that are relevant to chronic treatment of severe depression. These data points validate the compound's pharmacological design and provide strong support for the planned Investigational New Drug (IND) application."
Novel Neuroplastogen Approach
EB-003 represents the lead compound from Enveric's proprietary EVM301 Series, a pipeline of next-generation neuroplastogens engineered to stimulate synaptic plasticity without incurring hallucinogenic liability. The compound is designed as a potential first-in-class neuroplastogen to promote neuroplasticity without inducing hallucinations in patients suffering from difficult-to-address mental health disorders.
Enveric leverages its unique discovery and development platform Psybrary™, which houses proprietary information on the use and development of existing and novel molecules for specific mental health indications. The company is focused on advancing EB-003 toward clinical trials for neuropsychiatric disorders while out-licensing other novel, patented platform drug candidates to third-party licensees.
