Awakn Life Sciences Provides Update on R&D Programs, Progressing Novel Therapeutics for Alcohol Use Disorder and PTSD
Awakn Life Sciences (CSE: AWKN, OTC: AWKNF) provided updates on three R&D programs targeting substance use and mental health disorders:
1. AWKN-001: A Phase 3 ketamine-based combination therapy with CBT for severe Alcohol Use Disorder (AUD) in the UK, co-funded with MRC/NIHR. Awakn's costs are capped at £800,000. Targeting 8-10 years market exclusivity.
2. AWKN-002: A proprietary oral thin film esketamine formulation for moderate to severe AUD in the US. FDA confirmed 505(b)(2) NDA pathway eligibility with no additional clinical data needed before Phase 2b trials. IND submission planned for H2 2025, with Phase 2b trial application in H1 2026.
3. AWKN-SND-14: Pre-clinical serotonin, dopamine, and noradrenaline modulators for trauma-related disorders, including PTSD, designed to promote pro-social behavior with potentially improved safety profile.
Awakn Life Sciences (CSE: AWKN, OTC: AWKNF) ha fornito aggiornamenti su tre programmi di R&D mirati a disturbi legati all'uso di sostanze e alla salute mentale:
1. AWKN-001: Una terapia combinata a base di ketamina in Fase 3 con CBT per il Disturbo da Uso di Alcol (AUD) grave nel Regno Unito, co-finanziata con MRC/NIHR. I costi di Awakn sono limitati a £800.000. Si prevede un'esclusività di mercato di 8-10 anni.
2. AWKN-002: Una formulazione proprietaria di esketamina in film sottile orale per AUD moderato a grave negli Stati Uniti. La FDA ha confermato l'idoneità del percorso NDA 505(b)(2) senza necessità di ulteriori dati clinici prima delle prove di Fase 2b. La presentazione dell'IND è pianificata per la seconda metà del 2025, con la richiesta per la prova di Fase 2b nel primo semestre del 2026.
3. AWKN-SND-14: Modulatore preclinico della serotonina, dopamina e noradrenalina per disturbi legati a traumi, inclusa la PTSD, progettato per promuovere comportamenti pro-sociali con un profilo di sicurezza potenzialmente migliorato.
Awakn Life Sciences (CSE: AWKN, OTC: AWKNF) proporcionó actualizaciones sobre tres programas de I+D dirigidos a trastornos por consumo de sustancias y problemas de salud mental:
1. AWKN-001: Una terapia combinada a base de ketamina en Fase 3 con CBT para el Trastorno por Uso de Alcohol (AUD) grave en el Reino Unido, cofinanciada con MRC/NIHR. Los costos de Awakn están limitados a £800,000. Se espera una exclusividad de mercado de 8-10 años.
2. AWKN-002: Una formulación oral de película delgada de esketamina para AUD moderado a grave en los EE. UU. La FDA confirmó la elegibilidad del camino NDA 505(b)(2) sin necesidad de datos clínicos adicionales antes de los ensayos de Fase 2b. La presentación del IND está programada para la segunda mitad de 2025, con la solicitud para el ensayo de Fase 2b en la primera mitad de 2026.
3. AWKN-SND-14: Moduladores preclínicos de serotonina, dopamina y noradrenalina para trastornos relacionados con traumas, incluida la PTSD, diseñados para promover comportamientos pro-sociales con un perfil de seguridad potencialmente mejorado.
Awakn Life Sciences (CSE: AWKN, OTC: AWKNF)는 물질 사용 및 정신 건강 장애를 목표로 하는 세 가지 연구 및 개발(R&D) 프로그램에 대한 업데이트를 제공했습니다:
1. AWKN-001: 영국에서 심각한 알코올 사용 장애(AUD)를 위한 CBT와 결합한 3상 케타민 기반 요법입니다. MRC/NIHR와 공동 자금 지원을 받으며, Awakn의 비용은 £800,000로 제한됩니다. 8-10년간의 시장 독점권을 목표로 하고 있습니다.
2. AWKN-002: 미국에서 중등도에서 심각한 AUD를 위한 독점적인 경구형 얇은 필름 에스케타민 제형입니다. FDA는 추가 임상 데이터 없이 2b상 시험 전에 505(b)(2) NDA 경로 적절성을 확인했습니다. IND 제출은 2025년 하반기로 계획되어 있으며, 2b상 시험 신청은 2026년 상반기에 예정되어 있습니다.
3. AWKN-SND-14: PTSD를 포함한 외상 관련 장애를 위한 세로토닌, 도파민, 노르아드레날린 조절제의 전임상 단계를 거친 것입니다. 프로 사회적 행동을 촉진하고 잠재적으로 개선된 안전성 프로파일을 가질 수 있도록 설계되었습니다.
Awakn Life Sciences (CSE: AWKN, OTC: AWKNF) a fourni des mises à jour sur trois programmes de recherche et développement ciblant les troubles liés à l'utilisation de substances et la santé mentale :
1. AWKN-001 : Une thérapie combinée à base de kétamine en Phase 3 avec CBT pour le trouble d'utilisation d'alcool (AUD) sévère au Royaume-Uni, cofinancée avec MRC/NIHR. Les coûts d'Awakn sont plafonnés à 800 000 £. Une exclusivité de marché ciblée de 8 à 10 ans.
2. AWKN-002 : Une formulation propriétaire d'esketamine sous forme de film mince oral pour l'AUD modéré à sévère aux États-Unis. La FDA a confirmé l'éligibilité au chemin NDA 505(b)(2) sans besoin de données cliniques supplémentaires avant les essais de Phase 2b. La soumission de l'IND est prévue pour le second semestre de 2025, avec une demande d'essai de Phase 2b au premier semestre de 2026.
3. AWKN-SND-14 : Modulateurs précliniques de la sérotonine, de la dopamine et de la noradrénaline pour les troubles liés aux traumatismes, y compris le TSPT, conçus pour promouvoir un comportement pro-social avec un profil de sécurité potentiellement amélioré.
Awakn Life Sciences (CSE: AWKN, OTC: AWKNF) hat Updates zu drei F&E-Programmen gegeben, die sich auf Substanzmissbrauch und psychische Gesundheitsstörungen konzentrieren:
1. AWKN-001: Eine ketaminbasierte Kombinationstherapie der Phase 3 mit CBT für schwere Alkoholmissbrauchsstörungen (AUD) im Vereinigten Königreich, die zusammen mit MRC/NIHR kofinanziert wird. Die Kosten von Awakn sind auf 800.000 £ begrenzt. Eine Marktexklusivität von 8-10 Jahren wird angestrebt.
2. AWKN-002: Eine proprietäre orale dünne Filmformulierung von Esketamin für moderates bis schweres AUD in den USA. Die FDA hat die Eignung für den NDA-Weg 505(b)(2) bestätigt, ohne dass zusätzliche klinische Daten vor den Phase-2b-Studien erforderlich sind. Die IND-Einreichung ist für das zweite Halbjahr 2025 geplant, mit einem Antrag für die Phase-2b-Studie in der ersten Hälfte von 2026.
3. AWKN-SND-14: Vorklinische Modulatoren für Serotonin, Dopamin und Noradrenalin für traumaassoziierte Störungen, einschließlich PTSD, die darauf ausgelegt sind, prosoziales Verhalten zu fördern und ein potenziell verbessertes Sicherheitsprofil aufzuweisen.
- FDA approval for 505(b)(2) pathway for AWKN-002, expediting development process
- Secured government co-funding for AWKN-001 Phase 3 trial, limiting company costs to £800,000
- Potential for 8-10 years market exclusivity in UK for AWKN-001
- Clear regulatory pathway established for AWKN-002 with potential 5-year market exclusivity
- Phase 2b trials for AWKN-002 not starting until 2026, indicating lengthy development timeline
- AWKN-SND-14 still in early pre-clinical stage with uncertain timeline to market
Toronto, Ontario--(Newsfile Corp. - January 27, 2025) - Awakn Life Sciences Corp. (CSE: AWKN) (OTC Pink: AWKNF) (FSE: 954) ("Awakn" or the "Company"), a clinical-stage biotechnology company focused on developing therapeutics for substance use and mental health disorders, is pleased to provide an update on its research and development (R&D) programs.
Awakn currently has three main R&D programs:
1. AWKN-001
An investigational, novel combination therapy, consisting of an N-methyl-D-aspartate receptor-modulating drug (ketamine) delivered intravenously (IV) in combination with manualized relapse prevention cognitive behavioral therapy (CBT) for the treatment of severe Alcohol Use Disorder (AUD) in the UK and potentially the EU.
- Current Status: AWKN-001 is in Phase 3 in the UK. The trial is co-funded by a partnership between the UK's Medical Research Council (MRC) and the National Institute for Health and Care Research (NIHR), and Awakn Life Sciences Corp. It is managed by the University of Exeter Clinical Trials Unit. Awakn's costs for this trial are capped at GB£800,000 / CA
$1.4m .
- Regulatory Path and Exclusivity: Awakn is targeting a Regulation 52b hybrid application in the UK for AWKN-001. If successful, this could provide 8 years of market exclusivity, with an additional 2 years of supplementary protection, preventing competitors from marketing a similar product for the same indication.
2. AWKN-002
A proprietary oral thin film (OTF) formulation of esketamine for sublingual and buccal administration, developed in combination with structured alcohol education for moderate to severe Alcohol Use Disorder (AUD) in the U.S.
- Current Status: Awakn has in-licensed a Phase 1 program from LTS Lohmann Therapie-Systeme AG and completed two mechanistic studies in AUD with AWKN-002. These studies were used to file method-of-use patents. Awakn also completed a Pre-Investigational New Drug (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA), which confirmed that AWKN-002 can be reviewed under the 505(b)(2) NDA pathway. The FDA further confirmed that no additional clinical data are needed to proceed with a Phase 2b trial in patients with moderate to severe AUD.
- Regulatory Path and Exclusivity: Awakn plans to submit an IND Application for AWKN-002 in H2 2025, followed by a Clinical Trial Application ("CTA") for a Phase 2b trial in H1 2026. In due course, Awakn will submit a NDA under the 505(b)(2) pathway. The reference product for Awakn's NDA will be J&J's Spravato®, which is forecast to achieve US
$1b n in sales in 2024. Subject to successful clinical trial outcomes and FDA approval, AWKN-002 could be granted up to 5 years of market exclusivity in the US for the treatment of AUD, provided its patents are granted and recognised in the US Orange Book. Awakn anticipates that the Phase 2b clinical trial application will be made in 2026.
3. AWKN-SND-14
A series of serotonin, dopamine, and noradrenaline modulators under pre-clinical investigation for trauma-related mental health disorders, including Post-Traumatic Stress Disorder (PTSD). This program was previously referred to as Awakn's aminoindane new chemical entity program.
- Program Focus: AWKN-SND-14 is designed to promote pro-social behavior with a potentially improved safety profile compared to current investigational PTSD treatments. By enhancing trust, empathy, and social bonding-critical elements in addressing PTSD-AWKN-SND-14 aims to help individuals rebuild relationships, overcome isolation, and engage more effectively in therapy.
Anthony Tennyson, CEO of Awakn, commented: "We are excited about the progress across our key R&D programs, particularly in the areas of Alcohol Use Disorder and PTSD. With the advancements we've made in AWKN-001 and AWKN-002, we're on track to deliver transformative therapies for patients in need of more effective solutions."
Prof. David Nutt, Chief Research Officer of Awakn, added: "Our ongoing work with AWKN-SND-14 is especially promising, as it targets the underlying mechanisms of PTSD. We're optimistic about its potential to offer a safer, more effective option for individuals suffering from trauma-related disorders."
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 PTSD
PTSD is a debilitating mental health condition characterized by persistent and distressing symptoms resulting from exposure to traumatic events. Individuals with PTSD often experience intrusive memories, flashbacks, nightmares, hypervigilance, and avoidance behaviors, leading to significant impairment in daily functioning and overall well-being. Despite its prevalence, with an estimated 134 million adults in the US and with the Company estimating a current affected population of 20 million in the US and key European markets affected by PTSD, the condition remains underdiagnosed and underserved. Current treatment options often fall short in providing adequate relief, leaving many individuals without effective therapeutic solutions
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 and approximately 40 million in the 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.
www.awaknlifesciences.com | LinkedIn | X (formerly Twitter)
Notice Regarding Forward-Looking Information
This news release contains certain forward-looking information and forward-looking statements, as defined in applicable securities laws (collectively referred to herein as "forward-looking statements"). Forward-looking statements reflect current expectations or beliefs regarding future events or the Company's future performance. All statements other than statements of historical fact are forward-looking statements. Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "expects", "is expected", "budget", "scheduled", "estimates", "continues", "forecasts", "projects", "predicts", "intends", "anticipates", "targets" or "believes", or variations of, or the negatives of, such words and phrases or state that certain actions, events or results "may", "could", "would", "should", "might" or "will" be taken, occur or be achieved, including statements relating the business of the Company. All forward-looking statements, including those herein are qualified by this cautionary statement.
Although the Company believes that the expectations expressed in such statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those in the statements. There are certain factors that could cause actual results to differ materially from those in the forward-looking information. These include, but are not limited to: fluctuations in general macroeconomic conditions; the business plans and strategies of the Company; the ability of the Company to comply with all applicable governmental regulations in a highly regulated business; the inherent risks in investing in target companies or projects which have limited or no operating history and are engaged in activities currently considered illegal in some jurisdictions; changes in laws; limited operating history; reliance on management; requirements for additional financing; competition; fluctuations in securities markets; inconsistent public opinion and perception regarding the medical-use of psychedelic drugs; expectations regarding the size of the addiction market; and regulatory or political change. Readers are cautioned that the foregoing list of factors is not exhaustive of the factors that may affect forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements. The forward-looking statements in this news release speak only as of the date of this news release or as of the date or dates specified in such statements.
Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking information. For more information on the Company, investors are encouraged to review the Company's public filings on SEDAR at www.sedar.com. The Company disclaims any intention or obligation to update or revise any forward- looking information, whether as a result of new information, future events or otherwise, other than as required by law.
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
4 US VA National Center for PTSD. US Department of Veterans Affairs.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/238481
FAQ
When will Awakn Life Sciences (AWKNF) submit its IND application for AWKN-002?
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How much is Awakn's (AWKNF) financial commitment for the AWKN-001 Phase 3 trial?
What regulatory pathway has the FDA approved for AWKNF's AWKN-002?
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