Enveric Biosciences Presents Data on Lead Product Candidate, EB-003, at 7th Neuropsychiatric Drug Summit
Enveric Biosciences (NASDAQ: ENVB) presented data on its lead product candidate, EB-003, at the 7th Neuropsychiatric Drug Summit. EB-003 is a non-hallucinogenic, neuroplastogenic DMT analog that has shown positive outcomes in animal models of anxiety and depression. The presentation highlighted:
1. Preclinical data demonstrating EB-003's effectiveness in reducing anxiety and depression in mouse models.
2. Research on head twitch response (HTR), a behavioral proxy for hallucinogenic effects in humans.
3. Recent data confirming EB-003's oral bioavailability and ability to produce brain exposure at therapeutically relevant levels.
Enveric plans to file an Investigational New Drug (IND) application for EB-003 by Q3 2025 and initiate clinical development by the end of 2025. The company believes EB-003 is highly differentiated from similar drugs in development and has potential to be a significant value driver.
Enveric Biosciences (NASDAQ: ENVB) ha presentato dati sul suo principale candidato prodotto, EB-003, al 7° Neuropsychiatric Drug Summit. EB-003 è un analogo del DMT non allucinogeno e neuroplastogenico che ha mostrato risultati positivi in modelli animali di ansia e depressione. La presentazione ha messo in evidenza:
1. Dati preclinici che dimostrano l'efficacia di EB-003 nella riduzione di ansia e depressione in modelli murini.
2. Ricerca sulla risposta del movimento della testa (HTR), un indicatore comportamentale degli effetti allucinogeni negli esseri umani.
3. Dati recenti che confermano la biodisponibilità orale di EB-003 e la sua capacità di produrre esposizione cerebrale a livelli terapeuticamente rilevanti.
Enveric prevede di presentare una domanda di nuovo farmaco sperimentale (IND) per EB-003 entro il terzo trimestre del 2025 e di avviare lo sviluppo clinico entro la fine del 2025. L'azienda ritiene che EB-003 si differenzi notevolmente da farmaci simili in fase di sviluppo e abbia il potenziale per essere un significativo motore di valore.
Enveric Biosciences (NASDAQ: ENVB) presentó datos sobre su principal candidato a producto, EB-003, en la 7ª Cumbre de Medicamentos Neuropsiquiátricos. EB-003 es un análogode DMT no alucinógeno y neuroplastogénico que ha mostrado resultados positivos en modelos animales de ansiedad y depresión. La presentación destacó:
1. Datos preclínicos que demuestran la efectividad de EB-003 para reducir la ansiedad y la depresión en modelos de ratón.
2. Investigación sobre la respuesta de sacudida de cabeza (HTR), un indicador conductual de los efectos alucinógenos en humanos.
3. Datos recientes que confirman la biodisponibilidad oral de EB-003 y su capacidad para producir exposición cerebral a niveles terapéuticamente relevantes.
Enveric planea presentar una solicitud de Nuevo Medicamento en Investigación (IND) para EB-003 para el tercer trimestre de 2025 y comenzar el desarrollo clínico a finales de 2025. La empresa cree que EB-003 está altamente diferenciado de medicamentos similares en desarrollo y tiene el potencial de ser un importante generador de valor.
엔버릭 바이오사이언스(NASDAQ: ENVB)는 제7회 신경정신약물 정상 회담에서 주요 제품 후보인 EB-003에 대한 데이터를 발표했습니다. EB-003은 비환각성, 신경가소성 DMT 유사체로서 불안 및 우울증 동물 모델에서 긍정적인 결과를 보여주었습니다. 발표에서는 다음과 같은 사항이 강조되었습니다:
1. EB-003의 불안 및 우울증 감소 효능을 보여주는 전임상 데이터.
2. 인간의 환각 효과의 행동적 대리인인 머리 떨림 반응(HTR)에 대한 연구.
3. EB-003의 경구 생체이용률 및 치료적으로 관련된 수준에서 뇌 노출 생성 능력을 확인하는 최근 데이터.
엔버릭은 2025년 3분기까지 EB-003에 대한 임상시험용 신약(IND) 신청서를 제출하고 2025년 말까지 임상 개발을 시작할 계획입니다. 회사는 EB-003이 개발 중인 유사 약물과 훨씬 차별화되며, 상당한 가치 창출 잠재력이 있다고 믿고 있습니다.
Enveric Biosciences (NASDAQ: ENVB) a présenté des données sur son principal candidat produit, EB-003, lors du 7ème Sommet sur les Médicaments Neuropsychiatriques. EB-003 est un analogue de DMT non hallucinogène et neuroplastogène qui a montré des résultats positifs dans des modèles animaux d'anxiété et de dépression. La présentation a mis en évidence :
1. Des données précliniques démontrant l'efficacité d'EB-003 pour réduire l'anxiété et la dépression dans des modèles murins.
2. Une recherche sur la réponse de tremblement de tête (HTR), un indicateur comportemental des effets hallucinogènes chez l'homme.
3. Des données récentes confirmant la biodisponibilité orale d'EB-003 et sa capacité à produire une exposition cérébrale à des niveaux thérapeutiquement pertinents.
Enveric prévoit de soumettre une demande de nouveau médicament d'investigation (IND) pour EB-003 d'ici le troisième trimestre 2025 et de débuter le développement clinique d'ici la fin de 2025. L'entreprise estime qu'EB-003 est fortement différencié des médicaments similaires en développement et qu'il a le potentiel de devenir un moteur de valeur significatif.
Enveric Biosciences (NASDAQ: ENVB) hat Daten zu seinem Hauptproduktkandidaten, EB-003, beim 7. Neuropsychiatrischen Arzneimittelsymposium präsentiert. EB-003 ist ein nicht-halluzinogener, neuroplastogener DMT-Analoge, der positive Ergebnisse in Tiermodellen von Angstzuständen und Depressionen gezeigt hat. Der Vortrag hob hervor:
1. Präklinische Daten, die die Wirksamkeit von EB-003 bei der Reduzierung von Angstzuständen und Depressionen in Mausmodellen demonstrieren.
2. Forschung zur Kopfzuckreaktion (HTR), einem Verhaltensindikator für halluzinogene Effekte beim Menschen.
3. Neueste Daten, die die orale Bioverfügbarkeit von EB-003 und die Fähigkeit zur Gehirnexposition auf therapeutisch relevanten Ebenen bestätigen.
Enveric plant, bis zum 3. Quartal 2025 einen Antrag auf Prüfpräparat (IND) für EB-003 einzureichen und bis Ende 2025 mit der klinischen Entwicklung zu beginnen. Das Unternehmen ist der Ansicht, dass sich EB-003 signifikant von ähnlichen Wirkstoffen in der Entwicklung unterscheidet und das Potenzial hat, ein wesentlicher Werttreiber zu sein.
- EB-003 showed positive outcomes in preclinical models of anxiety and depression
- EB-003 demonstrated oral bioavailability and ability to produce brain exposure at therapeutically relevant levels
- Enveric plans to file an IND application for EB-003 by Q3 2025
- Clinical development of EB-003 is expected to begin by the end of 2025
- Clinical trials for EB-003 have not yet begun
- IND application for EB-003 is still pending
Presentation showcases the profile of EB-003, a non-hallucinogenic, neuroplastogenic DMT analog, which has shown positive outcomes in animal models of anxiety and depression
The presentation titled, “Non-hallucinogenic and neuroplastogenic DMT analog imparts positive behavioral outcomes in mice,” addresses the criteria researchers evaluated in the design and development of EB-003 as a non-hallucinogenic derivative of DMT for the treatment of neuropsychiatric disorders, including depression and anxiety. The poster highlights key preclinical data involving EB-003, including two mouse models demonstrating the effectiveness of EB-003 in reducing anxiety and depression, and research examining head twitch response (HTR), a behavioral proxy in rodents for hallucinogenic effects in humans.
This data adds to the library of research supporting the advancement of EB-003 as Enveric’s lead drug candidate. Recently, Enveric reported preclinical data confirming the oral bioavailability of EB-003 and its ability to produce brain exposure at therapeutically relevant levels. Enveric expects to file an Investigational New Drug (IND) application for EB-003 by the third quarter of 2025 and initiate clinical development by the end of 2025.
“The research being presented at the 7th Neuropsychiatric Drug Summit was foundational in our selection of EB-003 as our lead product candidate given its potential ability to treat resistant mental health disorders without the hallucinogenic effect typically associated with DMT-based molecules and related analogs,” said Joseph Tucker, Ph.D., Chief Executive Officer of Enveric. “Coupled with recent evidence demonstrating the ability of EB-003 to achieve optimal brain exposure after oral dosing, this research affirms our belief that EB-003 is highly differentiated from similar drugs in development and has the potential to be a significant value driver for Enveric and our shareholders.”
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, a next generation synthetic prodrug of the active metabolite, psilocin, being studied as a treatment for 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,” “schedules,” “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.
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Source: Enveric Biosciences
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