Enveric Biosciences Announces Preclinical Results Confirming Potential of EB-003 to be Dosed Orally
Enveric Biosciences (NASDAQ: ENVB) announced promising preclinical results for EB-003, a novel neuroplastogenic molecule designed to treat severe mental health disorders without hallucinogenic effects. The study revealed good oral bioavailability and significant brain exposure in rodent models, with a brain:plasma exposure ratio of ~1.5. EB-003 also demonstrated stability against human monoamine oxidase-A (MAO-A) and in various liver microsomes, unlike DMT and similar analogs.
Based on these results, Enveric is accelerating EB-003's evaluation in animal efficacy models. The company expects to file an IND application by Q3 2025 and initiate clinical development by the end of 2025. This advancement supports Enveric's patient-centered approach, aiming to develop non-hallucinogenic treatments with favorable pharmacological properties that enhance patient adherence and reduce treatment burden.
Enveric Biosciences (NASDAQ: ENVB) ha annunciato risultati preclinici promettenti per EB-003, una nuova molecola neuroplastogenica progettata per trattare gravi disturbi mentali senza effetti allucinogeni. Lo studio ha rivelato una buona biodisponibilità orale e un'esposizione significativa al cervello in modelli murini, con un rapporto esposizione cervello:plasma di ~1.5. EB-003 ha anche dimostrato stabilità contro la monoamino ossidasi A (MAO-A) umana e in vari microsomi epatici, diversamente da DMT e analoghi simili.
Basandosi su questi risultati, Enveric sta accelerando la valutazione di EB-003 in modelli di efficacia animale. L'azienda prevede di presentare una domanda IND entro il terzo trimestre del 2025 e iniziare lo sviluppo clinico entro la fine del 2025. Questo progresso supporta l'approccio incentrato sul paziente di Enveric, mirato a sviluppare trattamenti non allucinogeni con favorevoli proprietà farmacologiche che migliorano l'aderenza del paziente e riducono il peso del trattamento.
Enveric Biosciences (NASDAQ: ENVB) anunció resultados preclínicos prometedores para EB-003, una nueva molécula neuroplastogénica diseñada para tratar trastornos mentales severos sin efectos alucinógenos. El estudio reveló una buena biodisponibilidad oral y una exposición significativa al cerebro en modelos de roedores, con una relación de exposición cerebro:plasma de aproximadamente 1.5. EB-003 también demostró estabilidad frente a la monoaminooxidasa A (MAO-A) humana y en varios microsomas hepáticos, a diferencia de la DMT y análogos similares.
Basado en estos resultados, Enveric está acelerando la evaluación de EB-003 en modelos de eficacia animal. La compañía espera presentar una solicitud IND para el tercer trimestre de 2025 y comenzar el desarrollo clínico a finales de 2025. Este avance apoya el enfoque centrado en el paciente de Enveric, que busca desarrollar tratamientos no alucinógenos con propiedades farmacológicas favorables que mejoren la adherencia del paciente y reduzcan la carga del tratamiento.
엔베릭 생명과학(나스닥: ENVB)은 환각 효과 없이 심각한 정신 건강 장애를 치료하도록 설계된 새로운 신경가소성 분자 EB-003의 유망한 전임상 결과를 발표했습니다. 연구에서 좋은 경구 생체이용률과 의미 있는 뇌 노출가 설치류 모델에서 나타났으며, 뇌:혈장 노출 비율은 약 1.5로 확인되었습니다. EB-003는 DMT 및 유사한 유사체와 달리 인간 모노아민 산화효소 A(MAO-A) 및 다양한 간 미세소체에 대한 안정성도 입증했습니다.
이러한 결과를 바탕으로 엔베릭은 EB-003의 동물 효능 모델 평가를 가속화하고 있습니다. 이 회사는 2025년 3분기까지 IND 신청서를 제출하고 2025년 말까지 임상 개발을 시작할 것으로 예상하고 있습니다. 이 발전은 환자를 중심에 둔 엔베릭의 접근 방식을 지원하며, 환각이 없는 치료법을 개발하여 환자의 순응도를 높이고 치료 부담을 줄이는 것을 목표로 하고 있습니다.
Enveric Biosciences (NASDAQ: ENVB) a annoncé des résultats précliniques prometteurs pour EB-003, une nouvelle molécule neuroplastogénique conçue pour traiter des troubles mentaux graves sans effets hallucinogènes. L'étude a révélé une bonne biodisponibilité orale et une exposition significative au cerveau dans des modèles de rongeurs, avec un rapport exposition cerveau:plasma d'environ 1,5. EB-003 a également montré une stabilité vis-à-vis de la monoamine oxydase-A (MAO-A) humaine et dans divers microsomes hépatiques, contrairement à la DMT et à des analogues similaires.
Sur la base de ces résultats, Enveric accélère l'évaluation d'EB-003 dans des modèles d'efficacité animale. L'entreprise prévoit de déposer une demande IND d'ici le troisième trimestre 2025 et de commencer le développement clinique d'ici la fin de 2025. Cette avancée soutient l'approche centrée sur le patient d'Enveric, visant à développer des traitements non hallucinogènes avec des propriétés pharmacologiques favorables qui améliorent l'adhésion des patients et réduisent le fardeau des traitements.
Enveric Biosciences (NASDAQ: ENVB) hat vielversprechende präklinische Ergebnisse für EB-003 bekannt gegeben, ein neuartiges neuroplastogenes Molekül, das zur Behandlung schwerer psychischer Erkrankungen ohne halluzinogene Effekte entwickelt wurde. Die Studie zeigte eine gute orale Bioverfügbarkeit und signifikante Gehirnexposition in Nagetiermodellen, mit einem Gehirn-Plasma-Expositionsverhältnis von etwa 1,5. EB-003 zeigte auch Stabilität gegenüber menschlicher Monoaminoxidase A (MAO-A) und in verschiedenen Lebermikrosomen, im Gegensatz zu DMT und ähnlichen Analoga.
Basierend auf diesen Ergebnissen beschleunigt Enveric die Bewertung von EB-003 in Tierwirksamkeitsmodellen. Das Unternehmen rechnet damit, bis zum dritten Quartal 2025 einen IND-Antrag einzureichen und bis Ende 2025 mit der klinischen Entwicklung zu beginnen. Dieser Fortschritt unterstützt den patientenorientierten Ansatz von Enveric, der darauf abzielt, nicht-halluzinogene Behandlungen mit günstigen pharmakologischen Eigenschaften zu entwickeln, die die Patientenadhärenz verbessern und die Behandlungslast verringern.
- EB-003 demonstrated good oral bioavailability and brain penetration in preclinical studies
- The drug candidate showed stability against human MAO-A and various liver microsomes
- Enveric is accelerating EB-003's evaluation in animal efficacy models
- IND application filing expected by Q3 2025
- Clinical development initiation planned by the end of 2025
- Clinical trials have not yet begun, indicating a long timeline before potential market approval
- Efficacy in human subjects remains unproven at this stage
Insights
The preclinical results for Enveric Biosciences' EB-003 are indeed promising, particularly in terms of its oral bioavailability and brain penetration. This is a significant step forward in the development of neuroplastogenic compounds for mental health disorders. The brain:plasma exposure ratio of ~1.5 indicates good central nervous system penetration, which is important for a drug targeting neuropsychiatric conditions.
What's particularly noteworthy is EB-003's stability against monoamine oxidase-A (MAO-A) and various liver microsomes. This stability addresses a major limitation of DMT and similar compounds, which are rapidly metabolized and thus not orally bioavailable. The potential for oral administration could be a game-changer in terms of patient compliance and ease of use.
However, it's important to note that these are still early-stage results. The company's accelerated timeline, aiming for an IND filing by Q3 2025 and clinical development initiation by end of 2025, is ambitious. While promising, many drug candidates fail in later stages of development, so cautious optimism is warranted.
The non-hallucinogenic nature of EB-003, if confirmed in human trials, could potentially broaden the applicability of psychedelic-inspired treatments, making them more accessible to a wider patient population. This could be a significant market differentiator for Enveric Biosciences.
The preclinical data on EB-003 presents an intriguing profile for a novel neuroplastogen. The compound's ability to penetrate the blood-brain barrier effectively, as evidenced by the favorable brain:plasma ratio, is important for its intended neuropsychiatric applications. This characteristic, combined with its oral bioavailability, sets EB-003 apart from traditional psychedelic compounds.
The stability against MAO-A is particularly significant. MAO-A is a key enzyme in the metabolism of many neurotransmitters and psychoactive compounds. EB-003's resistance to MAO-A degradation not only enables oral administration but could also potentially lead to a more consistent and prolonged therapeutic effect.
However, it's critical to remember that in vitro and rodent model results don't always translate directly to human efficacy. The upcoming in vivo animal efficacy models will be important in determining the optimal therapeutic indication and dose range. These studies will provide valuable insights into EB-003's potential efficacy and safety profile before moving into human trials.
The non-hallucinogenic nature of EB-003, if maintained in human subjects, could represent a paradigm shift in neuroplastogen-based therapies. It potentially offers the neuroplastic benefits associated with psychedelics without the perceptual alterations that can be challenging for some patients. This could significantly expand the potential patient population and treatment settings for such therapies.
Confirmation of oral bioavailability and significant brain exposure in rodent models supports expedited development of EB-003, with Investigational New Drug (IND) filing and first patient dosed expected in 2025
EB-003 exhibited good oral bioavailability and brain penetration in a mouse pharmacokinetic study, with a brain:plasma exposure ratio of ~1.5. Furthermore EB-003 demonstrated significant in vitro stability against human monoamine oxidase-A (MAO-A) as well as in mouse, rat, dog, and human liver microsomes. By contrast, DMT and similar analogs are not orally available due to rapid metabolism by MAO-A.
Based on these results, Enveric is accelerating its evaluation of EB-003 in several in vivo animal efficacy models to determine the optimal therapeutic indication for clinical development and expected dose range. Enveric now expects to file an IND application for EB-003 by the third quarter of 2025 and initiate clinical development by the end of 2025.
“We continue to believe that EB-003 is substantially differentiated from the various psychedelic-inspired compounds in development. Not only does EB-003 offer the potential to significantly reduce or eliminate the hallucinogenic side-effect common to DMT and related analogs, but we now have confirmation that EB-003 can potentially be administered orally and penetrate the brain at levels expected to elicit the desired therapeutic effect,” said Joseph Tucker, Ph.D., CEO of Enveric. “We believe these results support our decision to advance EB-003 as our lead candidate and pursue a development timeline intended to enable the initiation of a clinical program and dosing of a first patient by end of 2025.”
“Burdensome drug delivery methods, like injections, may not be appealing to patients and can result in compliance challenges, often leading to the discontinuation of treatment altogether,” said Dr. Tucker. “Confirming that EB-003 can potentially be dosed orally is an important milestone, and we believe supports our overarching, patient-centered mindset, that non-hallucinogenic treatments must have favorable pharmacological properties that support patient adherence and reduce the treatment burden as they work to improve their mental health.”
About Enveric Biosciences
Enveric Biosciences (NASDAQ: ENVB) is a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, and addiction disorders. Leveraging its unique discovery and development platform, Psybrary™, Enveric has created a robust intellectual property portfolio of new chemical entities for specific mental health indications. Enveric’s lead program, EB-003, is a first-in-class approach to the treatment of difficult-to-address mental health disorders designed to promote neuroplasticity without inducing hallucinations in the patient. Enveric is also developing EB-002, formerly EB-373, a next generation synthetic prodrug of the active metabolite, psilocin, being studied as a treatment of psychiatric disorders. Enveric is headquartered in
Forward-Looking Statements
This press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward-looking statements or information. Generally, forward-looking statements and information may be identified by the use of forward-looking terminology such as “plans,” “expects” or “does not expect,” “proposes,” “budgets,” “explores,” “schedules,” “seeks,” “estimates,” “forecasts,” “intends,” “anticipates” or “does not anticipate,” or “believes,” or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, should, would, or might occur or be achieved. Forward-looking statements may include statements regarding beliefs, plans, expectations, or intentions regarding the future and are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the ability of Enveric to: negotiate and finalize definitive agreements based on the any of its out-licensing term sheets and perform pursuant to the terms thereof; carry out successful clinical programs; achieve the value creation contemplated by technical developments; avoid delays in planned clinical trials; establish that potential products are efficacious or safe in preclinical or clinical trials; establish or maintain collaborations for the development of therapeutic candidates; obtain appropriate or necessary governmental approvals to market potential products; obtain future funding for product development and working capital on commercially reasonable terms; scale-up manufacture of product candidates; respond to changes in the size and nature of competitors; hire and retain key executives and scientists; secure and enforce legal rights related to Enveric’s products, including patent protection; identify and pursue alternative routes to capture value from its research and development pipeline assets; continue as a going concern; and manage its future growth effectively.
A discussion of these and other factors, including risks and uncertainties with respect to Enveric, is set forth in Enveric’s filings with the Securities and Exchange Commission, including Enveric’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Enveric disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240725903859/en/
Investor Relations
Tiberend Strategic Advisors, Inc.
David Irish
(231) 632-0002
dirish@tiberend.com
Media Relations
Tiberend Strategic Advisors, Inc.
Casey McDonald
(646) 577-8520
cmcdonald@tiberend.com
Source: Enveric Biosciences
FAQ
What are the key preclinical results for Enveric Biosciences' EB-003?
When does Enveric Biosciences (ENVB) expect to file an IND for EB-003?
What is the target timeline for Enveric Biosciences (ENVB) to begin clinical trials for EB-003?
How does EB-003 differ from other psychedelic-inspired compounds in development?
