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Annovis Files Three New Patents for Combination Therapies Involving Buntanetap, Trulicity, and Viagra

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Annovis Bio Inc. (NYSE: ANVS) has filed three new patents for innovative combination therapies involving its lead compound, buntanetap. These patents cover combinations of buntanetap with Trulicity (dulaglutide), Viagra (sildenafil), or a combination of all three, aimed at treating neurodegenerative diseases like Alzheimer's and Parkinson's.

Recent preclinical studies have shown that combining buntanetap with a GLP-1 agonist (like Trulicity) or PDE5 inhibitors (like Viagra) improves cognitive function in Alzheimer's mouse models beyond levels observed in healthy controls. The company's CEO, Maria Maccecchini, Ph.D., stated that early data suggests a strong synergistic effect, potentially restoring and improving cognition beyond normal levels.

As buntanetap has completed Phase 3 studies as a standalone treatment, and both Trulicity and Viagra are FDA-approved, these combinations are well-positioned for Phase 3 human trials. This development expands Annovis's pipeline and advances its mission to enhance cognition for those suffering from neurodegenerative disorders.

Annovis Bio Inc. (NYSE: ANVS) ha presentato tre nuove domande di brevetto per terapie innovative in combinazione che coinvolgono il suo composto principale, buntanetap. Questi brevetti coprono le combinazioni di buntanetap con Trulicity (dulaglutide), Viagra (sildenafil) o una combinazione di tutti e tre, mirati al trattamento di malattie neurodegenerative come l'Alzheimer e il Parkinson.

Recenti studi preclinici hanno dimostrato che combinare buntanetap con un agonista GLP-1 (come Trulicity) o inibitori della PDE5 (come Viagra) migliora la funzione cognitiva nei modelli murini di Alzheimer oltre i livelli osservati nei controlli sani. L'amministratore delegato dell'azienda, Maria Maccecchini, Ph.D., ha dichiarato che i primi dati suggeriscono un forte effetto sinergico, potenzialmente ripristinando e migliorando la cognizione oltre i livelli normali.

Poiché buntanetap ha completato gli studi di Fase 3 come trattamento autonomo e sia Trulicity che Viagra sono approvati dalla FDA, queste combinazioni sono ben posizionate per prove cliniche di Fase 3 sugli esseri umani. Questo sviluppo amplia il portafoglio di Annovis e avanza la sua missione di migliorare la cognizione per coloro che soffrono di disturbi neurodegenerativi.

Annovis Bio Inc. (NYSE: ANVS) ha presentado tres nuevas patentes para terapias innovadoras en combinación que involucran su compuesto principal, buntanetap. Estas patentes cubren combinaciones de buntanetap con Trulicity (dulaglutide), Viagra (sildenafil) o una combinación de los tres, con el objetivo de tratar enfermedades neurodegenerativas como Alzheimer y Parkinson.

Estudios preclínicos recientes han mostrado que la combinación de buntanetap con un agonista GLP-1 (como Trulicity) o inhibidores de PDE5 (como Viagra) mejora la función cognitiva en modelos de ratón con Alzheimer, superando los niveles observados en controles sanos. La CEO de la compañía, Maria Maccecchini, Ph.D., declaró que los datos iniciales sugieren un fuerte efecto sinérgico, que potencialmente podría restaurar y mejorar la cognición más allá de los niveles normales.

Dado que buntanetap ha completado estudios de Fase 3 como tratamiento independiente y tanto Trulicity como Viagra están aprobados por la FDA, estas combinaciones están bien posicionadas para ensayos clínicos en Fase 3 en humanos. Este desarrollo amplía la cartera de Annovis y avanza su misión de mejorar la cognición para quienes sufren de trastornos neurodegenerativos.

Annovis Bio Inc. (NYSE: ANVS)는 주요 화합물인 buntanetap과 관련된 혁신적인 복합 요법에 대해 세 가지 새로운 특허를 출원했습니다. 이 특허는 buntanetap과 Trulicity (dulaglutide), Viagra (sildenafil) 또는 이 셋의 조합을 포함하여 알츠하이머 및 파킨슨병과 같은 신경퇴행성 질환 치료를 목표로 하고 있습니다.

최근의 전임상 연구는 buntanetap과 GLP-1 작용제(예: Trulicity) 또는 PDE5 억제제(예: Viagra)를 조합하면 알츠하이머 쥐 모델에서 인지 기능이 건강한 대조군보다 더욱 향상된다는 것을 보여주었습니다. 회사의 CEO인 Maria Maccecchini 박사는 초기 데이터가 강력한 시너지 효과를 나타내며, 정상 이상의 인지 기능을 회복하고 개선할 가능성이 있다고 밝혔습니다.

buntanetap이 독립 치료제로 3상 연구를 완료했으며, Trulicity와 Viagra가 모두 FDA 승인을 받은 만큼, 이러한 조합은 3상 인간 시험을 위한 좋은 위치에 있습니다. 이 개발은 Annovis의 파이프라인을 확장하고 신경퇴행성 장애로 고통받는 사람들의 인지를 향상시키려는 사명을 발전시킵니다.

Annovis Bio Inc. (NYSE: ANVS) a déposé trois nouveaux brevets pour des thérapies innovantes combinées impliquant son composé principal, buntanetap. Ces brevets couvrent des combinaisons de buntanetap avec Trulicity (dulaglutide), Viagra (sildenafil) ou une combinaison des trois, visant à traiter des maladies neurodégénératives telles que la maladie d'Alzheimer et le Parkinson.

Des études précliniques récentes ont montré que la combinaison de buntanetap avec un agoniste GLP-1 (comme Trulicity) ou des inhibiteurs de la PDE5 (comme Viagra) améliore la fonction cognitive dans des modèles murins de la maladie d'Alzheimer au-delà des niveaux observés chez des témoins sains. La PDG de l'entreprise, Maria Maccecchini, Ph.D., a déclaré que les premières données suggèrent un fort effet synergique, pouvant potentiellement restaurer et améliorer la cognition au-delà des niveaux normaux.

Puisque buntanetap a terminé des études de phase 3 en tant que traitement autonome et que Trulicity et Viagra sont tous deux approuvés par la FDA, ces combinaisons sont bien placées pour des essais humains de phase 3. Ce développement élargit le portefeuille d'Annovis et fait avancer sa mission d'améliorer la cognition des personnes souffrant de troubles neurodégénératifs.

Annovis Bio Inc. (NYSE: ANVS) hat drei neue Patente für innovative Kombinationstherapien eingereicht, die ihren Hauptbestandteil, buntanetap, betreffen. Diese Patente decken Kombinationen von buntanetap mit Trulicity (Dulaglutid), Viagra (Sildenafil) oder einer Kombination aller drei ab und haben das Ziel, neurodegenerative Erkrankungen wie Alzheimer und Parkinson zu behandeln.

Jüngste präklinische Studien haben gezeigt, dass die Kombination von buntanetap mit einem GLP-1-Agonisten (wie Trulicity) oder PDE5-Hemmern (wie Viagra) die kognitive Funktion in Alzheimer-Mausmodellen über die in gesunden Kontrollen beobachteten Werte hinaus verbessert. Die CEO des Unternehmens, Maria Maccecchini, Ph.D., erklärte, dass erste Daten auf einen starken synergistischen Effekt hindeuten, der möglicherweise die Kognition über Normalwerte hinaus wiederherstellt und verbessert.

Da buntanetap die Phase-3-Studien als eigenständige Behandlung abgeschlossen hat und sowohl Trulicity als auch Viagra von der FDA zugelassen sind, sind diese Kombinationen gut für Phase-3-Studien am Menschen positioniert. Diese Entwicklung erweitert die Pipeline von Annovis und fördert die Mission, die Kognition derjenigen zu verbessern, die unter neurodegenerativen Erkrankungen leiden.

Positive
  • Filing of three new patents for combination therapies, potentially expanding treatment options
  • Preclinical studies show cognitive improvement beyond healthy control levels
  • Combination therapies well-positioned for Phase 3 human trials due to existing approvals
  • Expansion of company's pipeline and intellectual property portfolio
Negative
  • None.

Insights

This patent filing for combination therapies is a significant development in Annovis Bio's strategy to combat neurodegenerative diseases. The combination of buntanetap with Trulicity and Viagra represents a novel approach that could potentially revolutionize treatment for Alzheimer's and Parkinson's diseases.

The preclinical data suggesting cognitive improvement beyond healthy control levels is particularly intriguing. If these results translate to human trials, it could mark a paradigm shift in how we approach cognitive enhancement in neurodegenerative disorders. The use of already FDA-approved drugs (Trulicity and Viagra) in combination with buntanetap may accelerate the path to Phase 3 trials, potentially reducing development time and costs.

However, investors should note that preclinical success doesn't guarantee clinical efficacy. The complex nature of neurodegenerative diseases means that human trials may yield different results. Nevertheless, this multi-pronged approach targeting different pathways simultaneously is a promising direction in a field that has seen many setbacks.

Annovis Bio's filing of three new patents for combination therapies is a strategic move to strengthen its intellectual property portfolio and potentially create new revenue streams. This approach of combining their lead compound buntanetap with established drugs like Trulicity and Viagra is clever for several reasons:

  • It extends the potential patent life of buntanetap through new combination claims.
  • It leverages the established safety profiles of FDA-approved drugs, potentially streamlining the regulatory process.
  • It creates a barrier to entry for competitors and positions Annovis as an innovator in combination therapies for neurodegenerative diseases.

The company's market position could significantly improve if these combinations prove effective in human trials. However, investors should be aware that patent filings don't guarantee approval or market exclusivity. The success of this strategy will ultimately depend on clinical trial outcomes and the company's ability to navigate the complex landscape of pharmaceutical patents and regulatory approvals.

MALVERN, Pa., Sept. 30, 2024 (GLOBE NEWSWIRE) -- via IBN – Annovis Bio Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company developing transformative therapies for neurodegenerative disorders such as Alzheimer’s disease (AD) and Parkinson’s disease (PD), today announced the filing of three new patents for innovative combination therapies involving its lead compound, buntanetap. These patents cover combinations of buntanetap with Trulicity (dulaglutide), Viagra (sildenafil), or a combination of all three, creating a multifaceted approach to treating neurodegenerative diseases.

Buntanetap, the Company’s lead drug asset, inhibits the production of neurotoxic proteins and has been shown to improve cognition in early AD patients (NCT05686044) and halt cognitive decline in PD patients (NCT05357989). Recent preclinical studies have demonstrated that when buntanetap is combined with a GLP-1 agonist (such as Trulicity) or PDE5 inhibitors (such as Viagra), cognitive function in Alzheimer’s mouse models improves to levels beyond those observed in healthy controls. With these compelling results demonstrating strong potential for cognition-enhancing combinations, Annovis further strengthens its intellectual property portfolio through the filing of the following patents:

  • Buntanetap + Trulicity (dulaglutide, a GLP-1 agonist).
  • Buntanetap + Viagra (sildenafil, a PDE5 inhibitor).
  • Buntanetap + Trulicity + Viagra.

“Our early data suggests a strong synergistic effect from combining these drugs, resulting in significant cognitive enhancement,” said Maria Maccecchini, Ph.D., Founder, President, and CEO of Annovis Bio. “The combination of buntanetap with Trulicity and Viagra not only has the potential to restore cognition to healthy levels, but also to improve it beyond normal, offering new hope in the fight against dementia. Since buntanetap has completed Phase 3 studies as a standalone treatment, and both Trulicity and Viagra are FDA-approved, these combinations are well-positioned for Phase 3 human trials.”

By leveraging the proven efficacy of Trulicity and Viagra in combination with buntanetap, Annovis is expanding its pipeline and advancing its mission to enhance cognition for those suffering from neurodegenerative disorders.

About Annovis Bio, Inc.

Headquartered in Malvern, Pennsylvania, Annovis Bio Inc. is dedicated to addressing neurodegeneration in diseases such as AD and PD. The company’s innovative approach targets multiple neurotoxic proteins, aiming to restore brain function and improve the quality of life for patients. For more information, visit www.annovisbio.com and follow us on LinkedIn, YouTube, and X.

Investor Alerts

Interested investors and shareholders are encouraged to sign up for press releases and industry updates by registering for Email Alerts at https://www.annovisbio.com/email-alerts. Additionally, we invite you to explore our updated investor website, which provides comprehensive access to company news, financial reports, and other key information.

Forward-Looking Statements

This press release contains "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, the Company's plans related to clinical trials. Forward-looking statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Such risks and uncertainties include, but are not limited to, those related to patient enrollment, the effectiveness of Buntanetap, and the timing, effectiveness, and anticipated results of the Company's clinical trials evaluating the efficacy, safety, and tolerability of Buntanetap. Additional risk factors are detailed in the Company's periodic filings with the SEC, including those listed in the "Risk Factors" section of the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. All forward-looking statements in this press release are based on information available to the Company as of the date of this release. The Company expressly disclaims any obligation to update or revise its forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.

Contact Information:
Annovis Bio Inc.
101 Lindenwood Drive
Suite 225
Malvern, PA 19355
www.annovisbio.com

Investor Contact:
Scott McGowan
InvestorBrandNetwork (IBN)
Phone: 310.299.1717
www.annovisbio.com/investors-relations
IR@annovisbio.com


FAQ

What new patents has Annovis Bio (ANVS) filed for combination therapies?

Annovis Bio has filed three new patents for combination therapies involving buntanetap with Trulicity (dulaglutide), Viagra (sildenafil), and a combination of all three for treating neurodegenerative diseases.

What results have preclinical studies shown for Annovis Bio's (ANVS) combination therapies?

Preclinical studies have demonstrated that combining buntanetap with Trulicity or Viagra improves cognitive function in Alzheimer's mouse models beyond levels observed in healthy controls.

How does Annovis Bio's (ANVS) buntanetap work in treating neurodegenerative diseases?

Buntanetap, Annovis Bio's lead drug asset, inhibits the production of neurotoxic proteins and has been shown to improve cognition in early Alzheimer's patients and halt cognitive decline in Parkinson's patients.

What is the potential advantage of Annovis Bio's (ANVS) new combination therapies?

The combination therapies have the potential to not only restore cognition to healthy levels but also improve it beyond normal, offering new hope in the fight against dementia.

Annovis Bio, Inc.

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