Psychedelics biotech company Enveric Biosciences (NASDAQ:ENVB) completed preclinical pharmacokinetic (PK) studies for its leading drug candidate EB-003 aimed at treating depression and anxiety without causing hallucinations. EB-003 is a neuroplastic and non-hallucinogenic N, N-Dimethyltryptamine (DMT) analog drug candidate., such as ataxia or hyperthermia.

"Completion of these animal PK studies further supports our efforts to develop conveniently delivered, orally-available drugs with the potential to harness neuroplastic properties without inducing hallucinations," stated Joseph Tucker, Ph.D., CEO of Enveric. "The additional data gained in these animal studies enhances our understanding of the preclinical profile of this drug candidate and brings us a step closer to finalizing the data package for the EB-003 Investigational New Drug (IND) application, which we anticipate submitting to the U.S. Food and Drug Administration in the second half of 2025."

Additionally, significant brain penetration was demonstrated in the rat model with a brain/plasma ratio of about 5-6, which is significantly higher than in previous mouse studies. This suggests enhanced efficacy, lower doses and less off-target side effects if these findings are confirmed in clinical trials.

Read Also: Enveric Biosciences Trims Losses, Eyes Key Drug Approval For Difficult-To-Treat Mental Health Disorders

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"Mental health disorders like depression and anxiety are on the rise, with approximately one billion people globally expected to experience a neuropsychiatric disorder at some time in their lives," Tucker continued. "Despite the prevalence of these conditions, currently approved treatments fail to provide adequate relief for half of the patients who try them, resulting in widespread challenges to the psychiatric community. The market opportunity for neuroplastogens is estimated to exceed $35 billion by 2030, with the potential to offer low side-effects, strong efficacy, and potential synergies with current drugs, which could help drive demand for new and innovative treatment options."

This update on EB-003 follows the company's announcement of securing five new U.S. patents for its EVM301 portfolio. These latest additions bring Enveric's total to nine issued U.S. patents, enhancing the intellectual property surrounding its library of neuroplasticity-focused compounds aimed at mental health conditions.

Price Action

Enveric Biosciences shares closed Friday's market session 0.24% higher at 33 cents per share.

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