Enveric Biosciences Announces Oral Dosing Potential of EB-003 in Preclinical Results

Enveric Biosciences, a biotechnology firm focusing on innovative neuroplastogenic treatments for neuropsychiatric conditions, has announced promising preclinical results for its drug candidate, EB-003. This compound, designed to be administered orally, exhibited significant brain exposure in rodent models at potential therapeutic doses.

EB-003 is a unique molecule developed to address severe mental health disorders without causing the hallucinogenic effects often linked with DMT and similar psychedelic compounds. The preclinical studies highlighted that EB-003 has good oral bioavailability and brain penetration in mice, showing a brain-to-plasma exposure ratio of around 1.5. Additionally, EB-003 demonstrated substantial stability against human monoamine oxidase-A (MAO-A) and in liver microsomes from mice, rats, dogs, and humans. This differentiates it from DMT and its analogs, which are not orally available due to rapid metabolism by MAO-A.

In light of these promising results, Enveric is accelerating the assessment of EB-003 across various in vivo animal efficacy models. The aim is to determine the optimal therapeutic applications and appropriate dose ranges. The company plans to file an Investigational New Drug (IND) application for EB-003 by the third quarter of 2025 and initiate clinical trials by the end of that year.

Joseph Tucker, Ph.D., CEO of Enveric, emphasized the distinctive nature of EB-003 compared to other psychedelic-inspired compounds in development. He noted that EB-003 not only potentially eliminates the hallucinogenic side effects associated with DMT but also can be administered orally to achieve significant brain penetration. This supports the company's decision to advance EB-003 as its lead candidate and pursue a development timeline aimed at starting a clinical program by the end of 2025.

Dr. Tucker also highlighted the importance of oral administration in ensuring patient compliance. He pointed out that complicated drug delivery methods, such as injections, may deter patients and lead to treatment discontinuation. The oral dosing potential of EB-003 marks an important milestone, reinforcing Enveric's patient-centered approach. The non-hallucinogenic nature of EB-003, along with favorable pharmacological properties, is expected to support patient adherence and reduce the burden of treatment, aiding in the improvement of mental health.

Enveric Biosciences, headquartered in Naples, Florida, with offices in Cambridge, Massachusetts, and Calgary, Alberta, Canada, is dedicated to developing innovative neuroplastogenic small-molecule therapeutics for treating depression, anxiety, and addiction disorders. Utilizing its proprietary discovery and development platform, Psybrary™, Enveric has built a strong intellectual property portfolio of new chemical entities targeting specific mental health issues.

EB-003 represents a first-in-class approach aimed at promoting neuroplasticity without causing hallucinations. Additionally, the company is developing EB-002, a next-generation synthetic prodrug of psilocin, intended for treating psychiatric disorders.

Enveric’s commitment to pioneering mental health treatments is underscored by its efforts to advance EB-003 through the necessary preclinical and clinical stages, with the goal of offering a novel, patient-friendly therapeutic option by late 2025.