Awakn Announces Positive Outcome of Pre-IND Meeting with FDA for AWKN-002 in Alcohol Use Disorder
Awakn Life Sciences (CSE: AWKN, OTC: AWKNF) announces a positive Pre-IND meeting outcome with the FDA for AWKN-002, their proprietary oral thin film formulation of esketamine for Alcohol Use Disorder (AUD) treatment. The FDA meeting, held on December 16, 2024, confirmed that no additional clinical data is needed before initiating a Phase 2b trial.
The FDA agreed to review AWKN-002 under the 505(b)(2) New Drug Application pathway, allowing the use of data from an approved esketamine product once a scientific bridge between AWKN-002 and the reference product is established. The company plans to submit its IND application and begin Phase 2b clinical trials after establishing this scientific bridge.
Awakn Life Sciences (CSE: AWKN, OTC: AWKNF) annuncia un esito positivo dell'incontro Pre-IND con la FDA riguardo a AWKN-002, la loro formulazione orale a film sottile di esketamina per il trattamento del Disturbo da Uso di Alcol (AUD). L'incontro della FDA, tenutosi il 16 dicembre 2024, ha confermato che non sono necessari ulteriori dati clinici prima di avviare un trial di Fase 2b.
La FDA ha acconsentito a esaminare AWKN-002 secondo il percorso di Richiesta di Nuovo Farmaco 505(b)(2), consentendo l'uso di dati provenienti da un prodotto di esketamina approvato, una volta stabilito un ponte scientifico tra AWKN-002 e il prodotto di riferimento. L'azienda prevede di presentare la propria domanda IND e di avviare i trial clinici di Fase 2b dopo aver stabilito questo ponte scientifico.
Awakn Life Sciences (CSE: AWKN, OTC: AWKNF) anuncia un resultado positivo en la reunión Pre-IND con la FDA para AWKN-002, su formulación oral en película delgada de esketamina para el tratamiento del Trastorno por Consumo de Alcohol (AUD). La reunión con la FDA, que se celebró el 16 de diciembre de 2024, confirmó que no se necesitan datos clínicos adicionales antes de iniciar un ensayo de Fase 2b.
La FDA acordó revisar AWKN-002 bajo la ruta de Solicitud de Nuevo Medicamento 505(b)(2), permitiendo el uso de datos de un producto de esketamina aprobado una vez que se establezca un puente científico entre AWKN-002 y el producto de referencia. La empresa planea presentar su solicitud IND y comenzar los ensayos clínicos de Fase 2b después de establecer este puente científico.
Awakn Life Sciences (CSE: AWKN, OTC: AWKNF)는 AWKN-002, 알코올 사용 장애(AUD) 치료를 위한 자사의 독점적인 경구용 얇은 필름 형식의 에스케타민에 대한 FDA의 긍정적인 Pre-IND 회의 결과를 발표했습니다. 2024년 12월 16일에 개최된 FDA 회의에서 2b상 시험을 시작하기 전에 추가 임상 데이터가 필요하지 않다는 것이 확인되었습니다.
FDA는 AWKN-002를 505(b)(2) 신약 신청 경로에 따라 검토하기로 동의했으며, 이는 AWKN-002와 참조 제품 간의 과학적 연결이 확립되면 승인된 에스케타민 제품의 데이터를 사용할 수 있도록 합니다. 회사는 이 과학적 연결을 확립한 후 IND 신청서를 제출하고 2b상 임상 시험을 시작할 계획입니다.
Awakn Life Sciences (CSE: AWKN, OTC: AWKNF) annonce une issue positive de la réunion Pre-IND avec la FDA concernant AWKN-002, leur formulation orale en film fin d'esketamine pour le traitement du trouble lié à l'alcool (AUD). La réunion avec la FDA, qui a eu lieu le 16 décembre 2024, a confirmé qu'aucune donnée clinique supplémentaire n'est nécessaire avant de commencer un essai de phase 2b.
La FDA a accepté d'examiner AWKN-002 dans le cadre de la procédure de demande de nouveau médicament 505(b)(2), permettant l'utilisation des données d'un produit d'esketamine approuvé une fois qu'un pont scientifique entre AWKN-002 et le produit de référence est établi. L'entreprise prévoit de soumettre sa demande IND et de commencer les essais cliniques de phase 2b après avoir établi ce pont scientifique.
Awakn Life Sciences (CSE: AWKN, OTC: AWKNF) gibt ein positives Ergebnis des Pre-IND-Meetings mit der FDA für AWKN-002 bekannt, ihre proprietäre orale Dünnfilmformulierung von Esketamin zur Behandlung von Alkoholkonsumstörung (AUD). Das Treffen mit der FDA, das am 16. Dezember 2024 stattfand, bestätigte, dass vor Beginn einer Phase 2b-Studie keine zusätzlichen klinischen Daten erforderlich sind.
Die FDA stimmte zu, AWKN-002 im Rahmen des 505(b)(2) New Drug Application-Verfahrens zu überprüfen, was die Verwendung von Daten aus einem genehmigten Esketaminprodukt ermöglicht, sobald eine wissenschaftliche Brücke zwischen AWKN-002 und dem Referenzprodukt hergestellt ist. Das Unternehmen plant, seinen IND-Antrag einzureichen und die klinischen Studien der Phase 2b zu beginnen, nachdem diese wissenschaftliche Brücke etabliert ist.
- FDA approval to proceed directly to Phase 2b trials without additional clinical data requirements
- Acceptance of 505(b)(2) pathway, potentially reducing development time and costs
- Clear regulatory pathway established for AWKN-002 development
- Scientific bridge to reference product still needs to be established before Phase 2b trials can begin
Toronto, Ontario--(Newsfile Corp. - January 20, 2025) - Awakn Life Sciences Corp. (CSE: AWKN) (OTC Pink: AWKNF) (FSE: 954) ("Awakn" or the "Company"), a clinical-stage biotechnology company developing therapeutics for substance use and mental health disorders, announces a positive outcome from its Pre-Investigational New Drug (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA), which took place on December 16, 2024. The meeting addressed the continued development of AWKN-002, a proprietary oral thin film (OTF) formulation of esketamine designed for sublingual and buccal administration in combination with structured alcohol education, being developed for moderate to severe alcohol use disorder (AUD).
The Pre-IND meeting provided an opportunity for the Company to discuss its Investigational New Drug (IND) development plan and receive FDA guidance on nonclinical and clinical study requirements for its new drug candidate. During the meeting, the FDA provided constructive feedback and expressed support for Awakn's proposed development strategy. Notably, the FDA confirmed that no additional clinical data are required prior to initiating a Phase 2b trial for AWKN-002 in patients with moderate to severe AUD.
The FDA also agreed that AWKN-002 can be reviewed under the 505(b)(2) New Drug Application (NDA) approval pathway, which allows the use of data from an approved esketamine product to support the development of AWKN-002 for AUD treatment once a scientific bridge between AWKN-002 and the reference product has been established.
Anthony Tennyson, Chief Executive Officer of Awakn, stated, "We are pleased with the outcome of our Pre-IND meeting with the FDA. The FDA's support for our development strategy, particularly their confirmation that we can proceed to Phase 2b once a suitable scientific bridge to the product has been established, marks a significant milestone for Awakn. This feedback provides us with a clear and efficient path forward in the development of AWKN-002, a novel treatment for AUD, an area of substantial unmet medical need."
Prof. David Nutt, Chief Research Officer of Awakn, added, "The FDA's recognition of our development strategy, and their willingness to support progression to Phase 2b, further validates the potential of AWKN-002 as a therapeutic for AUD. We look forward to continuing our work to bring this promising treatment to patients in need."
Awakn is planning to submit its IND application and initiate the Phase 2b clinical trial for AWKN-002 in patients with AUD once a scientific bridge to the reference product has been suitably established.
About AUD
Alcohol Use Disorder (AUD) is a chronic, relapsing brain health disorder characterized by compulsive alcohol use, loss of control over drinking, and negative emotional states when not using alcohol. It affects individuals across diverse demographics and can lead to a wide range of physical, psychological, and social consequences. AUD affects approximately 29 million1 adults in the US with the Company estimating a current affected population of 40 million in the US and US and key European markets. Despite this high prevalence treatment success rates are very low with up to
About Awakn Life Sciences Corp.
Awakn Life Sciences Corp. is a clinical-stage biotechnology company developing therapeutics targeting substance use and mental health disorders. Awakn has a near-term focus on AUD, a condition affecting approximately 29 million adults in the US with the Company estimating a current affected population of 40 million in the US and US and key European markets for which the current standard of care is inadequate. Our goal is to provide breakthrough therapeutics to addiction sufferers in desperate need and our strategy is focused on commercialising our R&D pipeline across multiple channels.
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Investor Enquiries:
Anthony Tennyson, CEO, Awakn Life Sciences
anthony.tennyson@awaknlifesciences.com
416-270-9566
1 Substance Abuse and Mental Health Administration, 2022 National Survey on Drug Use and Health (NSDUH).
2 Treatment rates for alcohol use disorders: a systematic review and meta-analysis, (Mekonen et al., 2021).
3 National Institute for Alcoholism and Alcohol Abuse (NIAAA), Economic Burden of Alcohol Misuse in the United States
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