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Awakn Announces Promising Results from Aminoindane New Chemical Entity Pre-Clinical Program

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Awakn Life Sciences has announced promising initial results from a preclinical study of its aminoindane series (AW21003) conducted at the University of Nottingham. The study focuses on developing new therapeutic options for trauma-related mental health disorders, particularly PTSD.

The compound AW21003 demonstrated enhanced social interaction and information transfer capabilities while showing a favorable safety profile compared to MDMA, with no observed stereotyped behaviors like flat body posture or lateral head weaving. The research targets a significant market, with PTSD affecting approximately 13 million adults in the U.S. and 20 million across the U.S., UK, and Europe.

Following these results, Awakn plans to expand its aminoindane program by synthesizing additional compounds in collaboration with Concept Life Sciences and conducting further preclinical behavioral studies at the University of Nottingham.

Awakn Life Sciences ha annunciato risultati iniziali promettenti da uno studio preclinico della sua serie di aminoindani (AW21003) condotto presso l'Università di Nottingham. Lo studio si concentra sullo sviluppo di nuove opzioni terapeutiche per i disturbi mentali legati al trauma, in particolare il PTSD.

Il composto AW21003 ha dimostrato capacità migliorate di interazione sociale e trasferimento di informazioni, mostrando un profilo di sicurezza favorevole rispetto all'MDMA, senza comportamenti stereotipati osservati come la postura corporea piatta o il movimento laterale della testa. La ricerca targeting un mercato significativo, con il PTSD che colpisce circa 13 milioni di adulti negli Stati Uniti e 20 milioni tra Stati Uniti, Regno Unito e Europa.

Dopo questi risultati, Awakn prevede di espandere il suo programma di aminoindani sintetizzando ulteriori composti in collaborazione con Concept Life Sciences e conducendo ulteriori studi comportamentali preclinici presso l'Università di Nottingham.

Awakn Life Sciences ha anunciado resultados iniciales prometedores de un estudio preclínico de su serie de aminoindanos (AW21003) llevado a cabo en la Universidad de Nottingham. El estudio se centra en desarrollar nuevas opciones terapéuticas para los trastornos de salud mental relacionados con el trauma, en particular el TEPT.

El compuesto AW21003 demostró capacidades mejoradas de interacción social y transferencia de información, mostrando un perfil de seguridad favorable en comparación con el MDMA, sin conductas estereotipadas observadas como la postura corporal plana o el movimiento lateral de la cabeza. La investigación apunta a un mercado significativo, con el TEPT afectando a aproximadamente 13 millones de adultos en EE.UU. y 20 millones en EE.UU., Reino Unido y Europa.

Tras estos resultados, Awakn planea expandir su programa de aminoindano sintetizando compuestos adicionales en colaboración con Concept Life Sciences y llevando a cabo más estudios de comportamiento preclínico en la Universidad de Nottingham.

Awakn Life Sciences는 노팅엄 대학교에서 실시한 아미노인단(aw21003) 시리즈의 전임상 연구에서 유망한 초기 결과를 발표했습니다. 이 연구는 트라우마와 관련된 정신 건강 장애, 특히 PTSD에 대한 새로운 치료 옵션 개발에 중점을 두고 있습니다.

화합물 AW21003는 사회적 상호작용과 정보 전달 능력이 향상되었으며 MDMA에 비해 안전성이 우수한 프로필을 나타냈으며, 평평한 신체 자세나 측면 머리 흔들기와 같은 관찰된 고정 행동은 없습니다. 이 연구는 미국에서 약 1300만 명의 성인과 미국, 영국, 유럽에서 2000만 명에 달하는 PTSD의 영향을 받는 상당한 시장을 목표로 하고 있습니다.

이러한 결과에 따라 Awakn은 Concept Life Sciences와 협력하여 추가 화합물을 합성하고 노팅엄 대학교에서 추가 전임상 행동 연구를 수행하여 아미노인단 프로그램을 확장할 계획입니다.

Awakn Life Sciences a annoncé des résultats initiaux prometteurs d'une étude préclinique de sa série d'aminoindanes (AW21003) réalisée à l'Université de Nottingham. L'étude se concentre sur le développement de nouvelles options thérapeutiques pour les troubles de la santé mentale liés aux traumatismes, en particulier le PTSD.

Le composé AW21003 a démontré des capacités améliorées d'interaction sociale et de transfert d'informations tout en présentant un profil de sécurité favorable par rapport à l'MDMA, sans comportements stéréotypés observés tels qu'une posture corporelle plate ou un balancement latéral de la tête. La recherche cible un marché significatif, avec le PTSD touchant environ 13 millions d'adultes aux États-Unis et 20 millions aux États-Unis, au Royaume-Uni et en Europe.

Suite à ces résultats, Awakn prévoit d'étendre son programme d'aminoindanes en synthétisant des composés supplémentaires en collaboration avec Concept Life Sciences et en menant d'autres études comportementales précliniques à l'Université de Nottingham.

Awakn Life Sciences hat vielversprechende erste Ergebnisse einer präklinischen Studie seiner Aminoindan-Serie (AW21003) bekannt gegeben, die an der Universität Nottingham durchgeführt wurde. Die Studie konzentriert sich auf die Entwicklung neuer Therapieoptionen für traumaassoziierte psychische Erkrankungen, insbesondere für PTBS.

Die Verbindung AW21003 zeigte verbesserte soziale Interaktionen und Informationsübertragungsfähigkeiten, während sie ein positives Sicherheitsprofil im Vergleich zu MDMA aufwies, ohne beobachtbare stereotypische Verhaltensweisen wie eine flache Körperhaltung oder seitliches Kopfschwingen. Die Forschung zielt auf einen bedeutenden Markt ab, da PTBS schätzungsweise etwa 13 Millionen Erwachsene in den USA und 20 Millionen in den USA, Großbritannien und Europa betrifft.

Basierend auf diesen Ergebnissen plant Awakn die Erweiterung seines Aminoindan-Programms, indem zusätzliche Verbindungen in Zusammenarbeit mit Concept Life Sciences synthetisiert und weitere präklinische Verhaltensstudien an der Universität Nottingham durchgeführt werden.

Positive
  • AW21003 demonstrated enhanced social interaction and information transfer capabilities
  • Showed favorable safety profile compared to MDMA with no adverse behavioral effects
  • Addresses large market opportunity with PTSD affecting 13M adults in US and 20M across US, UK, and Europe
Negative
  • Still in early preclinical stage, requiring further studies and validation
  • Test results showed complex outcomes requiring additional analysis

Toronto, Ontario--(Newsfile Corp. - December 10, 2024) - Awakn Life Sciences Corp. (CSE: AWKN) (OTCQB: AWKNF) (FSE: 954) ("Awakn" or the "Company"), a clinical-stage biotechnology company developing therapeutics for substance use and mental health disorders, today announces initial results from a preclinical study of its co-lead aminoindane series (AW21003) conducted by the University of Nottingham. This program focuses on new therapeutic options for trauma-related mental health disorders, particularly Post-Traumatic Stress Disorder (PTSD).

Aminoindanes are a class of compounds being explored in pre-clinical models by Awakn for their ability to promote pro-social behavior with a potentially improved safety profile compared to existing options under investigation for PTSD. Pro-social behavior, which includes actions that foster trust, empathy, and social bonding, is increasingly recognized as a key factor in addressing PTSD. Enhancing these behaviors could help individuals with PTSD overcome feelings of isolation, rebuild interpersonal relationships, and engage more effectively in therapeutic interventions.

Study Highlights:

  • Social Interaction and Information Transfer: AW21003 demonstrated the ability to enhance the speed at which observer animals consumed a demonstrated (correct) versus novel (incorrect) flavored diet, suggesting a positive impact on social transfer and retention of information.
  • Behavioral Safety Indicators: Unlike MDMA, the test standard, which is known to cause stereotyped behaviors such as flat body posture and lateral head weaving in similar studies, no such behaviors were observed in AW21003-treated animals. This suggests a favorable safety profile for AW21003.
  • Unique Observations: Test-standard treated animals unexpectedly showed a preference for the correct diet, suggesting baseline pro-social tendencies in the experimental design. AW21003-treated animals displayed complex outcomes in food intake preferences, warranting further analysis.

The study, announced on October 15, 2024, was led by Dr. Madeleine King, Assistant Professor in the School of Life Sciences in the Faculty of Medicine & Health Sciences at the University of Nottingham.

Awakn's aminoindane NCE program, developed in collaboration with Graft Polymer (UK) Plc, is designed to address significant unmet medical needs, including PTSD, which affects approximately 13 million adults in the U.S. and 20 million individuals across the U.S., UK, and Europe.

Next Steps

Based on these promising early results, Awakn will expand its aminoindane program to synthesize a further range of aminoindane compounds in collaboration with Concept Life Sciences. These compounds will be screened against serotonin, dopamine, and norepinephrine release. Additional preclinical behavioral studies with the University of Nottingham are also planned to further explore and validate the therapeutic potential of this class of compounds.

Dr. Madeleine King of the University of Nottingham, commented: "These findings appear extremely promising for the aminoindane new chemical entities. AW21003 showed positive effects on social transfer of information, without any of the additional unwanted behaviors induced MDMA. I am excited to continue our collaboration with Awakn as they move to the next phase of their pre-clinical program".

Professor David Nutt, Chief Research Officer of Awakn, commented: "These findings represent an important milestone in our aminoindane program. The ability to develop compounds that combine therapeutic efficacy with improved safety has transformative potential for treating PTSD and other trauma-related conditions."

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.sedarplus.ca. 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

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/233264

FAQ

What are the key findings of Awakn's (AWKNF) aminoindane study in December 2024?

The study showed AW21003 enhanced social interaction and information transfer with a better safety profile than MDMA, showing no stereotyped behaviors like flat body posture or lateral head weaving.

What is the market potential for Awakn's (AWKNF) PTSD treatment?

The treatment targets approximately 13 million adults with PTSD in the U.S. and 20 million individuals across the U.S., UK, and Europe.

What are Awakn's (AWKNF) next steps following the aminoindane study results?

Awakn plans to synthesize more aminoindane compounds with Concept Life Sciences and conduct additional preclinical behavioral studies at the University of Nottingham.

AWAKN LIFE SCIENCES CORP

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